Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-04-16 @ 6:28 PM
Study NCT ID:
NCT02732366
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2016-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cmm295@pitt.edu', 'phone': '4123834603', 'title': 'Christine M. McDonough, Assistant Professor of Physical Therapy', 'organization': 'University of Pittsburgh, Department of Physical Therapy'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From baseline to 6 months from baseline', 'description': 'Although falls were expected in this study, they were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Group-based Exercise and Peer Coaching', 'description': 'This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.\n\nGroup-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 10, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual PT and Attention Control Grp Class', 'description': 'This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.\n\nUsual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 10, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'pneumonia', 'notes': 'The participant experienced pneumonia and recovered.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'spine disorder', 'notes': 'Surgery for spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'colitis', 'notes': 'experienced symptoms related to colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Falls', 'notes': 'Falls', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary tract infection', 'notes': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'heart attack', 'notes': 'The participant reported having a heart attack during the follow-up period of the study, was treated in the hospital and by physician.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary tract infection', 'notes': 'the participant was admitted to the hospital for a urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Population', 'description': 'Number screened'}], 'classes': [{'title': 'Screened', 'categories': [{'measurements': [{'value': '342', 'groupId': 'OG000'}]}]}, {'title': 'Did not meet inclusion criteria', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}]}]}, {'title': 'Met at least one exclusion criterion met', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Eligible', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}]}]}, {'title': 'Not interested', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}, {'title': 'Unable to attend sessions', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Could not be reached', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Enrolled', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'To assess feasibility of the intervention, the number of patients identified as eligible, the number who refuse to participate, and the number who enroll in the study will be collected.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '342 older adults were screened for eligibility.'}, {'type': 'PRIMARY', 'title': 'Intervention and Control Group Program Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Exercise and Peer Coaching', 'description': 'Attendance to 8 intervention sessions for 6 groups'}, {'id': 'OG001', 'title': 'Usual PT and Attention Control Grp Class', 'description': 'Attendance to 6 control group sessions for 6 groups'}], 'classes': [{'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000'}, {'value': '95.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'To assess feasibility of the intervention, the percentage of sessions attended by patients enrolled in the study will be collected.', 'unitOfMeasure': 'percentage of sessions', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Program Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Exercise and Peer Coaching', 'description': 'This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.\n\nGroup-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.'}, {'id': 'OG001', 'title': 'Usual PT and Attention Control Grp Class', 'description': 'This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.\n\nUsual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'To assess feasibility of the intervention, the number of patients who complete the program will be collected.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants that attended 6 week program (non-withdrawals).'}, {'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Exercise and Peer Coaching', 'description': 'This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.\n\nGroup-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.'}, {'id': 'OG001', 'title': 'Usual PT and Attention Control Grp Class', 'description': 'This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.\n\nUsual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).'}], 'classes': [{'title': 'Number of Participants with AEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Number of Participants with falls', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'To assess safety of the intervention, patients will be instructed to report all adverse events to the clinical investigators.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intervention and control groups'}, {'type': 'PRIMARY', 'title': 'Adverse Events - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Exercise and Peer Coaching', 'description': 'This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.\n\nGroup-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.'}, {'id': 'OG001', 'title': 'Usual PT and Attention Control Grp Class', 'description': 'This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.\n\nUsual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).'}], 'classes': [{'title': 'Falls', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'All non-fall adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of Adverse Events', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Adverse Events'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group-based Exercise and Peer Coaching', 'description': 'This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.\n\nGroup-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.'}, {'id': 'FG001', 'title': 'Usual PT and Attention Control Grp Class', 'description': 'This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.\n\nUsual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Participant', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from physician and physical therapist practices in a rural regional hospital. The intervention and control conditions were provided as 8-week programs. Recruitment was coordinated to occur approximately 4 weeks prior to a scheduled program/session, until sufficient numbers of participants were identified.', 'preAssignmentDetails': 'Two participants withdrew after consenting and before randomization. Note that randomization was done in session blocks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group-based Exercise and Peer Coaching', 'description': 'This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.\n\nGroup-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.'}, {'id': 'BG001', 'title': 'Usual PT and Attention Control Grp Class', 'description': 'This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.\n\nUsual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75.6', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '77.2', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '76.4', 'spread': '6.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'missing: 1'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], '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': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Timed Up and Go (seconds)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '16.7', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '14.65', 'spread': '6.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Timed Up and Go is a physical performance measure that measures leg strength, mobility and fall risk using stopwatch, standard arm chair, and a line marked on the floor at 3 meters/10 feet away from the front edge of the chair. The participant may use walking aid and push off of the chair to stand up. The participant begins seated in the chair. When prompted with "Go" the participant stands, walk to the mark, turns, walks back an sits down. The results are reported in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '30 Second Chair Stand', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.89', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '8.24', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '8.56', 'spread': '3.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is a performance-based measure. The equipment needed includes a chair with a straight back without arm rests (seat 17 inches high) and a stopwatch. The participant sits in the chair, places hands on opposite shoulders crossed at the wrists with feet on the floor with back straight. On the verbal prompt "GO" the participant rises to a full standing position, sits back down, and repeats as many times as possible within 30 seconds. Age and gender-stratified thresholds have been established for fall risk.', 'unitOfMeasure': 'number of stands', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'There were 7 withdrawals from the study between randomization and baseline testing/program start. Therefore the baseline analysis population is 39.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-25', 'size': 370986, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-26T22:44', 'hasProtocol': True}, {'date': '2016-05-20', 'size': 128127, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-26T22:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2016-03-24', 'resultsFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2016-04-04', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-04', 'studyFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment', 'timeFrame': '6 months', 'description': 'To assess feasibility of the intervention, the number of patients identified as eligible, the number who refuse to participate, and the number who enroll in the study will be collected.'}, {'measure': 'Intervention and Control Group Program Attendance', 'timeFrame': '6 weeks', 'description': 'To assess feasibility of the intervention, the percentage of sessions attended by patients enrolled in the study will be collected.'}, {'measure': 'Program Completion', 'timeFrame': '6 weeks', 'description': 'To assess feasibility of the intervention, the number of patients who complete the program will be collected.'}, {'measure': 'Adverse Events', 'timeFrame': '6 months', 'description': 'To assess safety of the intervention, patients will be instructed to report all adverse events to the clinical investigators.'}, {'measure': 'Adverse Events - Number of Events', 'timeFrame': '6 months', 'description': 'Number of Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aged [MeSH term]', 'exercise [MeSH term]'], 'conditions': ['Accidental Falls']}, 'referencesModule': {'references': [{'pmid': '17018668', 'type': 'BACKGROUND', 'citation': 'Stevens JA, Corso PS, Finkelstein EA, Miller TR. The costs of fatal and non-fatal falls among older adults. Inj Prev. 2006 Oct;12(5):290-5. doi: 10.1136/ip.2005.011015.'}, {'pmid': '22868837', 'type': 'BACKGROUND', 'citation': 'Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204. doi: 10.7326/0003-4819-157-3-201208070-00462.'}], 'seeAlsoLinks': [{'url': 'http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5545a1.htm', 'label': 'Fatalities and injuries from falls among older adults - US 1993-2003 and 2001-2005. Morbidity and mortality weekly report. 2006'}, {'url': 'http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5709a1.htm', 'label': 'Self-reported falls and fall-related injuries among persons aged \\>65 years - US, 2006. Morbidity and mortality weekly report. 2008'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the feasibility and preliminary efficacy of a group-based fall prevention program for older adults.', 'detailedDescription': 'Falls are the leading cause of non-fatal and fatal injuries in older adults. The number of fall-related older adult deaths in 2005 reached 15,802. Overall, thirty percent of adults over the age of 65 fall every year, and the risk for falls increases dramatically with age. Direct medical costs related to falls reached $19 billion in 2000. In 2006 a national study found that 5.8 million older adults (16%) reported a fall in the prior 3 month period and 1.8 million had been injured. Falls and fall-related injuries have an important impact on mobility, functioning, and the quality of life of older adults, and for many, result in catastrophic mobility decline, loss of independence and institutionalization. The trends in falls and aging in the population make this a critical problem for our time.\n\nCurrent evidence and guidelines recommend assessment of several important risk factors and providing individualized intervention for older adults at increased risk of falls. Strength, balance and gait training are among the most potent intervention elements. Evidence shows that fall risk benefits gained from exercise are completely lost within 12 weeks if exercise is not continued. Therefore, persistence with exercise and physical activity are critical to the long-term success of fall prevention treatments. The proposed project tests the feasibility and preliminary efficacy of an innovative group-based fall prevention program called Living In Fitness Together (LIFT). The program consists of group-based physical therapy for strength, balance, mobility and flexibility training, an individualized home program including walking for physical activity, and training of the group members to support and coach each other toward meeting their exercise and physical activity goals. It consists of 8 group sessions over 6 weeks plus one group booster session delivered by a physical therapist, occupational therapist and trained staff. The program is designed to deliver progressive, tailored, and challenging exercise intervention for older adults at risk for falls and empower older adults to meet their goals for exercise and physical activity through training in self-management, and peer-coaching within the exercise group. The aim of this project is to test the feasibility of implementing the fall prevention program with peer-coaching in the context of physical therapy practice, and to assess its safety and initial efficacy. The results of this study will be the foundation of a formal clinical trial of a novel program of exercise and peer- coaching for exercise adherence. This program has potential to be incorporated into physical therapy practice and disseminated widely, and to have an important impact on the number of falls and fall-related injuries that occur in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adults aged 65 and over\n* at risk for falls as identified by health care provider\n* able to participate in group exercise with upper extremity support for balance (e.g. chair)\n\nExclusion Criteria:\n\n* active vertigo, postural hypotension, unstable cardiac conditions\n* major neurological disorders such as Parkinson's disease, recent major cerebrovascular event, multiple sclerosis, amyotrophic lateral sclerosis"}, 'identificationModule': {'nctId': 'NCT02732366', 'acronym': 'LIFT', 'briefTitle': 'Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention Program', 'orgStudyIdInfo': {'id': 'PRO18020039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group-based exercise and peer coaching', 'description': 'This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.', 'interventionNames': ['Behavioral: Group-based exercise and peer coaching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual PT and attention control grp class', 'description': 'This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.', 'interventionNames': ['Other: Usual PT and attention control grp class']}], 'interventions': [{'name': 'Group-based exercise and peer coaching', 'type': 'BEHAVIORAL', 'description': 'Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.', 'armGroupLabels': ['Group-based exercise and peer coaching']}, {'name': 'Usual PT and attention control grp class', 'type': 'OTHER', 'description': 'The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).', 'armGroupLabels': ['Usual PT and attention control grp class']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05089', 'city': 'Windsor', 'state': 'Vermont', 'country': 'United States', 'facility': 'Mount Ascutney Hospital and Health Center', 'geoPoint': {'lat': 43.48035, 'lon': -72.38481}}], 'overallOfficials': [{'name': 'Christine M McDonough, PT, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Department of Physical Therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mt. Ascutney Hospital and Health Center', 'class': 'OTHER'}, {'name': 'Foundation for Physical Therapy, Inc.', 'class': 'INDUSTRY'}, {'name': 'Boston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Physical Therapy', 'investigatorFullName': 'Christine McDonough', 'investigatorAffiliation': 'University of Pittsburgh'}}}}