Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 1:37 PM
Study NCT ID:
NCT04278560
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2020-02-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Modulating Brain Activity to Improve Goal-directed Physical Activity in Older Adults
Sponsor:
Organization:
Raw JSON
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Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.", 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 10, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mole excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Opthalmic migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bed bug infestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergy to chemicals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blepharoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral T-cell lymphoma unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Daily Step Counts From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'OG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'classes': [{'title': 'Week 3-4', 'categories': [{'measurements': [{'value': '842', 'spread': '281', 'groupId': 'OG000'}, {'value': '194', 'spread': '219', 'groupId': 'OG001'}]}]}, {'title': 'Week 5-6', 'categories': [{'measurements': [{'value': '1099', 'spread': '405', 'groupId': 'OG000'}, {'value': '408', 'spread': '443', 'groupId': 'OG001'}]}]}, {'title': 'Week 7-8', 'categories': [{'measurements': [{'value': '1299', 'spread': '439', 'groupId': 'OG000'}, {'value': '721', 'spread': '284', 'groupId': 'OG001'}]}]}, {'title': 'Week 9-10', 'categories': [{'measurements': [{'value': '1476', 'spread': '519', 'groupId': 'OG000'}, {'value': '866', 'spread': '448', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '385.3', 'pValueComment': 'Repeated Measures Two-Way ANOVA: Group, Time, Group x Time, and controlled by Baseline Step Counts', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3-4, Week 5-6, Week 7-8, and Week 9-10.', 'description': 'Absolute change in averaged daily step counts from two-week baseline (first two weeks, week 1-2). The specific periods are 1) absolute change in averaged daily step counts in week 3 and 4 from baseline, 2) absolute change in averaged daily step counts at week 5 and 6, from baseline, 3) absolute change in averaged daily step counts in week 7 and 8 from baseline, and 4) absolute change in averaged daily step counts in week 9 and 10 from baseline.', 'unitOfMeasure': 'Steps per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Motivation - External Regulation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'OG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': "External Regulation Score was calculated from the Exercise Self-Regulation Questionnaire (SQR-E). External regulation refers to motivation based on external sources such as incentives or coercion. Introjected regulation refers to motivation from an internalized, pressuring voice that was not accepting it as one's own. The External Regulation Score ranges from 4 to 28. The higher scores mean a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Timed Up-and-Go (TUG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'OG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '11.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '10.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.19', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'We used change from baseline for the analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'A common field test of mobility', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Trail Making Test (TMT) - A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'OG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '36.3', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '29.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '39.8', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '32.4', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '38.4', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'Trail making test (TMT) A is a neuropsychological test of visual attention. The test requires the patient to connect randomly positioned numbered circles in numeric order as quickly as possible. It provides information about visual search speed and speed of processing. The test reliability for TMT A is 0.82. Time is measured in seconds.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Trail Making Test (TMT) - B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'OG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '101.6', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '106.2', 'spread': '11.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '101.4', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '122.4', 'spread': '19.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '86.7', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '113.0', 'spread': '19.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '9.94', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'Trail Making Test (TMT) - B is a neuropsychological test of task switching. The test requires the participants to connect the circles in numeric and alphabetic order as quickly as possible, alternating between numbers and letters. It provides information about executive function. The test reliability for TMT-B is 0.93. Time is measured in seconds.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Montreal Cognitive Assessment (MoCA) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'OG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '24.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '24.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'Global cognitive function. The range for this test is 0-30, with higher score representing better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Geriatric Depression Scale (15-item)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'OG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.07', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'Number of depressive symptoms. The range for this test is 0-15, with lower score representing better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Completion Rate for Brain Stimulation Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'OG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'spread': '1', 'groupId': 'OG000'}, {'value': '99', 'spread': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Ten stimulation sessions were planned for each participant over two weeks. This outcome presents the percentage of the completed brain stimulation sessions.', 'unitOfMeasure': 'percentage of comleted sessions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Completion Rate for Behavior Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'OG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'spread': '2', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 10', 'description': 'Four bi-weekly behaviors sessions were planned for each participant over two months. This outcome presents the percentage of the completed behavior sessions.', 'unitOfMeasure': 'percentage of comleted sessions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'FG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Two participants signed the informed consent at the in-person screening but withdrew prior to the baseline assessment and were never randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Intervention Plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.\n\nTranscranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.'}, {'id': 'BG001', 'title': 'Behavioral Intervention Plus Sham Stimulation', 'description': "This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.\n\nSham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.\n\nBehavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.1', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '81.2', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '78.6', 'spread': '7.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-11', 'size': 204989, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-27T13:48', 'hasProtocol': True}, {'date': '2023-10-27', 'size': 539205, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-13T14:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2020-02-18', 'resultsFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-14', 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Daily Step Counts From Baseline', 'timeFrame': 'Week 3-4, Week 5-6, Week 7-8, and Week 9-10.', 'description': 'Absolute change in averaged daily step counts from two-week baseline (first two weeks, week 1-2). The specific periods are 1) absolute change in averaged daily step counts in week 3 and 4 from baseline, 2) absolute change in averaged daily step counts at week 5 and 6, from baseline, 3) absolute change in averaged daily step counts in week 7 and 8 from baseline, and 4) absolute change in averaged daily step counts in week 9 and 10 from baseline.'}], 'secondaryOutcomes': [{'measure': 'Motivation - External Regulation Score', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': "External Regulation Score was calculated from the Exercise Self-Regulation Questionnaire (SQR-E). External regulation refers to motivation based on external sources such as incentives or coercion. Introjected regulation refers to motivation from an internalized, pressuring voice that was not accepting it as one's own. The External Regulation Score ranges from 4 to 28. The higher scores mean a better outcome."}, {'measure': 'Timed Up-and-Go (TUG)', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'A common field test of mobility'}, {'measure': 'Trail Making Test (TMT) - A', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'Trail making test (TMT) A is a neuropsychological test of visual attention. The test requires the patient to connect randomly positioned numbered circles in numeric order as quickly as possible. It provides information about visual search speed and speed of processing. The test reliability for TMT A is 0.82. Time is measured in seconds.'}, {'measure': 'Trail Making Test (TMT) - B', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'Trail Making Test (TMT) - B is a neuropsychological test of task switching. The test requires the participants to connect the circles in numeric and alphabetic order as quickly as possible, alternating between numbers and letters. It provides information about executive function. The test reliability for TMT-B is 0.93. Time is measured in seconds.'}, {'measure': 'Montreal Cognitive Assessment (MoCA) Total Score', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'Global cognitive function. The range for this test is 0-30, with higher score representing better outcome.'}, {'measure': 'Geriatric Depression Scale (15-item)', 'timeFrame': 'Baseline; Week 4; Week 10', 'description': 'Number of depressive symptoms. The range for this test is 0-15, with lower score representing better outcome.'}, {'measure': 'Completion Rate for Brain Stimulation Sessions', 'timeFrame': 'Week 4', 'description': 'Ten stimulation sessions were planned for each participant over two weeks. This outcome presents the percentage of the completed brain stimulation sessions.'}, {'measure': 'Completion Rate for Behavior Sessions', 'timeFrame': 'Week 10', 'description': 'Four bi-weekly behaviors sessions were planned for each participant over two months. This outcome presents the percentage of the completed behavior sessions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'Although the majority of older adults are aware of the compelling evidence that regular exercise is critical to the maintenance of health into old age, most do not meet recommendations for daily exercise. This lack of engagement in \'goal-directed\' physical activity stems from numerous interrelated factors including lack of motivation, depressed mood, and cognitive "executive" impairments that diminish one\'s ability to regulate behavior over time. Intriguingly, each of these factors has been linked to the function of brain networks that include the left dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a noninvasive and safe means of modulating the excitability of specific brain regions and their connected neural networks. tDCS designed to facilitate the excitability of the left dlPFC has been shown to improve motivation, mood, and multiple aspects of executive function in healthy adults. The investigators thus hypothesize that tDCS holds promise to increase goal-directed physical activity in older adults. This project aims to conduct a pilot randomized controlled trial on the feasibility and effects of a 2-week, 10-session tDCS intervention targeting the left dlPFC, combined with behavioral intervention aimed at increases daily physical activity, on physical activity over a two-month follow-up period, in relatively sedentary older adults without overt illness or disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must live within subsidized housing in the Boston area\n* Self-report of exercising, on average, less than 150 minutes of at least moderate-intensity exercise per week, as determined by phone-screen completion of the International Physical Activity Questionnaire-Short Form (IPAQ short)\n\nExclusion Criteria:\n\n* An inability to ambulate without the assistance of another person (canes or walkers allowed)\n* Self-report of physician-diagnosed dementia, more than moderate cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score \\<21, or an inability to understand the study protocol as determined by study staff\n* A clinical history of stroke, Parkinson's disease or parkinsonian syndromes, multiple sclerosis, normal pressure hydrocephalus or other movement disorder affecting gait\n* Any report of severe lower-extremity arthritis or physician-diagnosis of peripheral neuropathy\n* Use of antipsychotics, anti-seizure, benzodiazepines, or other neuroactive medications\n* Severe depression defined by a Geriatric Depression Scale score greater than 11\n* Any report or physician-diagnosis of schizophrenia, bipolar disorder or other psychiatric illness\n* Any unstable medical condition\n* Resting systolic blood pressure is higher than 180 mmHg\n* Contraindications tor tDCS, including reported seizure within the past two years, use of neuro-active drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp"}, 'identificationModule': {'nctId': 'NCT04278560', 'acronym': 'Stim-Fit', 'briefTitle': 'Modulating Brain Activity to Improve Goal-directed Physical Activity in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Hebrew SeniorLife'}, 'officialTitle': 'Modulating Brain Activity to Improve Goal-directed Physical Activity in Older Adult', 'orgStudyIdInfo': {'id': 'IRB-2019-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral intervention plus tDCS', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.', 'interventionNames': ['Device: Transcranial direct current stimulation (tDCS)', 'Behavioral: Behavioral intervention to increase physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral intervention plus sham stimulation', 'description': 'This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.', 'interventionNames': ['Device: Sham stimulation', 'Behavioral: Behavioral intervention to increase physical activity']}], 'interventions': [{'name': 'Transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'description': 'tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.', 'armGroupLabels': ['Behavioral intervention plus tDCS']}, {'name': 'Sham stimulation', 'type': 'DEVICE', 'description': "An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.", 'armGroupLabels': ['Behavioral intervention plus sham stimulation']}, {'name': 'Behavioral intervention to increase physical activity', 'type': 'BEHAVIORAL', 'description': "Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.", 'armGroupLabels': ['Behavioral intervention plus sham stimulation', 'Behavioral intervention plus tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02131', 'city': 'Roslindale', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Hebrew Rehabilitation Center', 'geoPoint': {'lat': 42.29121, 'lon': -71.1245}}], 'overallOfficials': [{'name': 'Brad Manor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebrew SeniorLife'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'The investigators will make the data and associated documentation available once summary data are published or otherwise made available, starting six months after publication.', 'ipdSharing': 'YES', 'description': 'The HSL Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, physiologic, and brain imaging data, from all participants.\n\nAll data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.', 'accessCriteria': 'The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using data only for research purposes and not to identify any particular participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed. The availability of data will be advertised over the Internet through websites maintained by Hebrew SeniorLife and Harvard Medical School.\n\nAll investigators wishing to access the data will submit a brief proposal describing their research project, data needs, regulatory approvals, and mechanisms to assure patient confidentiality. Upon affirmative review by the Principal Investigator and co-investigators of this study, a data-sharing agreement will be signed and the requesting investigators will be given a working data file and appropriate documentation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebrew SeniorLife', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}