Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT02714257
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Working to Increase Stability Through Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'csciamanna@pennstatehealth.psu.edu', 'phone': '717-531-4417', 'title': 'Christopher Sciamanna, MD, MPH', 'organization': 'Milton S. Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data were collected every 4 months for the full 36-month duration of study participation.', 'description': 'Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.', 'eventGroups': [{'id': 'EG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.", 'otherNumAtRisk': 569, 'deathsNumAtRisk': 569, 'otherNumAffected': 0, 'seriousNumAtRisk': 569, 'deathsNumAffected': 22, 'seriousNumAffected': 162}, {'id': 'EG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.", 'otherNumAtRisk': 570, 'deathsNumAtRisk': 570, 'otherNumAffected': 0, 'seriousNumAtRisk': 570, 'deathsNumAffected': 30, 'seriousNumAffected': 79}], 'seriousEvents': [{'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective Joint Replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation/Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Coronary Syndrome / Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke / Transient Ischemic Attack / Intracranial Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid / Electrolyte Abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Imbalance (syncope, dizziness, vertigo)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 569, 'numEvents': 65, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 570, 'numEvents': 45, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'OG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'classes': [{'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.14', 'estimateComment': 'Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'Every 4 months the investigators will call the participants asking questions about the main outcome, FF/SFI. A fall calendar will be given to the participant to record all fall events (e.g., date, location). This will help participants to recall falls during the 4 month period. In addition, this will allow medical records to be requested, using a signed authorization form (part of the consent form). The investigators will review all relevant Electronic Health Records (EHR) information, such as hospital and emergency department discharge summaries, outpatient visit notes, consultation notes, physical exam notes, dictated radiologist notes and plain film radiography.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'OG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '0.95'}, {'value': '0.84', 'groupId': 'OG001', 'lowerLimit': '0.76', 'upperLimit': '0.93'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.28', 'estimateComment': 'Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention', 'statisticalMethod': 'Regression, Negative Binomial', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'The investigators will examine the number of falls, and fall-related injuries using two questions from the BRFSS.', 'unitOfMeasure': 'falls', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'OG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.11', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'The investigators will use a self-reported health question to assess key patient centered outcomes that the intervention may improve. This question is from the NIH-supported PROMIS. The outcome is categorized as excellent/very good health vs. good/fair/poor health as reported on the single question.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'OG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'classes': [{'categories': [{'measurements': [{'value': '11.65', 'groupId': 'OG000', 'lowerLimit': '10.96', 'upperLimit': '12.33'}, {'value': '11.11', 'groupId': 'OG001', 'lowerLimit': '10.45', 'upperLimit': '11.77'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.92', 'estimateComment': 'Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'The investigators will use the 7-item version of the Falls Efficacy Scale International (FES-I), used to quantify fear of falling in 7 different scenarios. Each item is scored 1-4, with higher scores being associated with greater fear. Total sum score is reported, possible range 7-28.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '529', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'OG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}, {'value': '50.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.27', 'estimateComment': 'Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': "The investigators will use 6 questions from the NHIS at baseline and the 36 month follow-up to measure participants' activity level. Percentage of participants with a sum of moderate and vigorous minutes \\>=150 is reported.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Physical Function Using PROMIS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'OG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'classes': [{'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG000', 'lowerLimit': '8.28', 'upperLimit': '9.72'}, {'value': '8.77', 'groupId': 'OG001', 'lowerLimit': '8.08', 'upperLimit': '9.47'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.62', 'estimateComment': 'Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'The investigators will use 4 physical function questions to assess physical function subscale of PROMIS. Each item ranges 1-5. Total sum score is reported; higher scores are associated with lower levels of physical function. Total sum score range, 4-20.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Depression Using PROMIS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'OG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'classes': [{'categories': [{'measurements': [{'value': '5.62', 'groupId': 'OG000', 'lowerLimit': '5.21', 'upperLimit': '6.03'}, {'value': '5.52', 'groupId': 'OG001', 'lowerLimit': '5.12', 'upperLimit': '5.91'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.34', 'estimateComment': 'Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'The investigators will use 4 depression questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.', 'unitOfMeasure': 'score on a scale of 4-20, higher=worse', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Anxiety Using PROMIS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'OG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'classes': [{'categories': [{'measurements': [{'value': '6.21', 'groupId': 'OG000', 'lowerLimit': '5.79', 'upperLimit': '6.64'}, {'value': '6.07', 'groupId': 'OG001', 'lowerLimit': '5.66', 'upperLimit': '6.48'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.38', 'estimateComment': 'Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'The investigators will use 4 anxiety questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.', 'unitOfMeasure': 'score on a scale of 4-20, higher=worse', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Loneliness Using PROMIS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'OG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'classes': [{'categories': [{'measurements': [{'value': '4.19', 'groupId': 'OG000', 'lowerLimit': '3.92', 'upperLimit': '4.46'}, {'value': '4.12', 'groupId': 'OG001', 'lowerLimit': '3.86', 'upperLimit': '4.38'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.22', 'estimateComment': 'Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'The investigators will use 3 loneliness questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.', 'unitOfMeasure': 'score on a scale of 3-9, higher=worse', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'FG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '569'}, {'groupId': 'FG001', 'numSubjects': '570'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '559'}, {'groupId': 'FG001', 'numSubjects': '549'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enhanced Usual Care - Control Group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'id': 'BG001', 'title': 'Enhanced Usual Care Plus Exercise Coaching Intervention', 'description': "Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.\n\nEnhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '73.2', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '73.2', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '73.2', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '479', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '961', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '517', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1025', 'groupId': 'BG002'}]}]}, {'title': 'Black or African-American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'More than One Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education Level', 'classes': [{'title': 'Less than high school', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': 'College, 1-3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}]}, {'title': 'College, 4 or more years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '323', 'groupId': 'BG001'}, {'value': '614', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Married/Living with partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '594', 'groupId': 'BG002'}]}]}, {'title': 'Divorced/Separated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}, {'title': 'Widowed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}]}, {'title': 'Never married', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '553', 'groupId': 'BG000'}, {'value': '557', 'groupId': 'BG001'}, {'value': '1110', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.6', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '28.6', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are missing for 29 participants, 13 in the exercise group and 16 in the control group.'}, {'title': 'Systolic Blood Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '129.7', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '129.4', 'spread': '17.8', 'groupId': 'BG001'}, {'value': '129.5', 'spread': '17.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'History of Osteoporosis', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '531', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '587', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Any fall in past year', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '561', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '283', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '545', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-04', 'size': 720943, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-09T16:12', 'hasProtocol': True}, {'date': '2018-10-17', 'size': 310323, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-09T16:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2016-02-22', 'resultsFirstSubmitDate': '2024-08-15', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-03', 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)', 'timeFrame': '36 months', 'description': 'Every 4 months the investigators will call the participants asking questions about the main outcome, FF/SFI. A fall calendar will be given to the participant to record all fall events (e.g., date, location). This will help participants to recall falls during the 4 month period. In addition, this will allow medical records to be requested, using a signed authorization form (part of the consent form). The investigators will review all relevant Electronic Health Records (EHR) information, such as hospital and emergency department discharge summaries, outpatient visit notes, consultation notes, physical exam notes, dictated radiologist notes and plain film radiography.'}], 'secondaryOutcomes': [{'measure': 'Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)', 'timeFrame': '36 months', 'description': 'The investigators will examine the number of falls, and fall-related injuries using two questions from the BRFSS.'}, {'measure': 'Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': '36 months', 'description': 'The investigators will use a self-reported health question to assess key patient centered outcomes that the intervention may improve. This question is from the NIH-supported PROMIS. The outcome is categorized as excellent/very good health vs. good/fair/poor health as reported on the single question.'}, {'measure': 'Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)', 'timeFrame': '36 months', 'description': 'The investigators will use the 7-item version of the Falls Efficacy Scale International (FES-I), used to quantify fear of falling in 7 different scenarios. Each item is scored 1-4, with higher scores being associated with greater fear. Total sum score is reported, possible range 7-28.'}, {'measure': 'Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)', 'timeFrame': '36 months', 'description': "The investigators will use 6 questions from the NHIS at baseline and the 36 month follow-up to measure participants' activity level. Percentage of participants with a sum of moderate and vigorous minutes \\>=150 is reported."}, {'measure': 'Assessment of Physical Function Using PROMIS', 'timeFrame': '36 months', 'description': 'The investigators will use 4 physical function questions to assess physical function subscale of PROMIS. Each item ranges 1-5. Total sum score is reported; higher scores are associated with lower levels of physical function. Total sum score range, 4-20.'}, {'measure': 'Assessment of Depression Using PROMIS', 'timeFrame': '36 months', 'description': 'The investigators will use 4 depression questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.'}, {'measure': 'Assessment of Anxiety Using PROMIS', 'timeFrame': '36 months', 'description': 'The investigators will use 4 anxiety questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.'}, {'measure': 'Assessment of Loneliness Using PROMIS', 'timeFrame': '36 months', 'description': 'The investigators will use 3 loneliness questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fractures, Bone']}, 'descriptionModule': {'briefSummary': 'The investigators propose a 36-month multi-center randomized effectiveness trial to compare the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching (Exercise), on Fragility Fractures and Serious Fall-Related Injuries (FF/SFRI) in patients with a previous fragility fracture (FF).\n\nThe investigators will also examine the impact of the intervention on several secondary outcomes like: loneliness, physical function, and bone strength. The investigators will do this by following a Pragmatic trial design: 1) limiting exclusions to increase representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting measures to those practicable for use in usual care.', 'detailedDescription': 'The intervention will be held in churches, community centers, and senior residential facilities. Investigators will work with the exercise sites to recruit up to 125 individuals (5 per exercise site location) to serve as the Group leaders at each site location. Group leaders will be trained on the exercises and leadership roles to help lead the group. The investigators will ask them to come at least once per week, so the time commitment is minimal.\n\nThe investigators will be recruiting 1130 patients who have suffered a fragility fracture and will randomly assign them to one of two conditions: (A) Control Group - Enhanced Usual Care and (B) Intervention Group - Enhanced usual care plus Exercise coaching that includes in-person and phone coach contacts to encourage and support strength, balance and walking activities.\n\n\\*Due to the COVID-19 pandemic, the in-person intervention was stopped in March of 2020 and a Zoom-based virtual intervention was introduced in April of 2020. Participants that join the zoom-based virtual intervention are lead by staffed exercise coaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 65 years old\n* Previous Fragility Fracture (FF) in past 10 years.\n* Able to speak and understand English.\n* Participants will need to be willing to try exercising and agree to annual follow-up measurements.\n\nExclusion Criteria:\n\nIf the answer to the following questions are "yes", the investigators will exclude the participant from the study Do you feel pain in your chest, neck, jaw, or arms at rest, during your daily activities of living, OR when you do physical activity? Have you ever been told by a health professional that you should not exercise OR exercise only when supervised by a professional?\n\nIf the answer to the following questions are "yes", the investigators will contact physician for permission Do you experience unpleasant awareness of a forceful or rapid heart rate? Do you experience unreasonable breathlessness? Do you experience dizziness fainting or blackouts? Do you experience ankle swelling? Do you have burning or cramping sensation on your lower legs when walking short distances? Do you have diabetes?\n\nHas a doctor, nurse or health professional ever told you that you had any of the following? Weak or failing kidneys? A heart attack, also called a myocardial infarction? Angina or coronary heart disease? A stroke? Any kind of heart condition or heart disease other than the ones I just asked about?\n\nUnable to obtain primary care provider consent (if required based on questions above)\n\nIf the participant answer "NO" to the following question: Is it ok if the investigators contact your primary care provider?\n\nIf the participant answer "YES" to the following question:Have you been hospitalized for psychiatric problem in past year?\n\nIf the participant is planning on moving out of the area in the next 36 months\n\nIf currently participates in the Band Together exercise program\n\nPositive Callahan cognition screener: If participant fails 2 questions, research coordinator will explain study in detail and ask read-back questions. The participant will be excluded if failed read-back.'}, 'identificationModule': {'nctId': 'NCT02714257', 'acronym': 'WISE', 'briefTitle': 'Working to Increase Stability Through Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Integrating Patient-Centered Exercise Coaching Into Primary Care to Reduce Fragility Fracture', 'orgStudyIdInfo': {'id': 'IRB-3576'}, 'secondaryIdInfos': [{'id': 'PCS-1406-18325-EXT', 'type': 'OTHER', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Enhanced Usual Care - control group', 'description': "Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure."}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Usual Care plus Exercise Coaching Intervention', 'description': "Participants will receive the three printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress.", 'interventionNames': ['Behavioral: Enhanced Usual Care plus Exercise Coaching']}], 'interventions': [{'name': 'Enhanced Usual Care plus Exercise Coaching', 'type': 'BEHAVIORAL', 'description': 'For month one of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.\n\nEvery month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.\n\nFor the individuals exercising at home, the investigators will distribute the exercise Digital Versatile Disc (DVDs) every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.', 'armGroupLabels': ['Enhanced Usual Care plus Exercise Coaching Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Christopher Sciamanna, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'Temple University', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Medicine and Public Health Sciences, Division Chief Population Health Research and Development', 'investigatorFullName': 'Christopher Sciamanna, MD, MPH', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}