Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-01-27 @ 12:57 PM
Study NCT ID:
NCT02295995
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2014-10-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exercise and PTSD in Older Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'katherine.hall@duke.edu', 'phone': '919-286-0411', 'title': 'Dr. Katherine S. Hall', 'phoneExt': '6734', 'organization': 'Durham VA HCS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The recruitment period started November 2015 and was originally planned to last 18 months, but was extended to 2 years due to various life events of the PI that caused delays in recruitment.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data were collected for 12 weeks (the duration of the intervention period).', 'eventGroups': [{'id': 'EG000', 'title': 'Exercise', 'description': 'Participants randomized to this arm were enrolled in a 12-week, supervised exercise program. 36 patients were randomized, of which 31 completed the intervention (included in analyses).', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Wait-List', 'description': 'Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks. 18 patients were randomized, of which 17 completed the study (included in analyses).', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Patient Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible Patients', 'description': 'Number of potentially eligible patients contacted to participate in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'The primary aim/outcome of this pilot study is the feasibility of recruiting older Veterans with PTSD to participate in a 12-week exercise program. The number of Veterans recruited out of the total number contacted will be determined at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '701 potentially eligible patients were identified, of which 380 were screened out. Leaving 321 eligible patients (the denominator). Of these 321, 168 declined participation, and 99 were unable to contact; leaving 54 that were enrolled/randomized (numerator).'}, {'type': 'PRIMARY', 'title': 'Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.'}, {'id': 'OG001', 'title': 'Usual Care Wait-List', 'description': 'Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '365.8', 'spread': '349.4', 'groupId': 'OG000'}, {'value': '349.4', 'spread': '122.2', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '1954.4', 'spread': '192.2', 'groupId': 'OG000'}, {'value': '675.3', 'spread': '178.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'groupDescription': "The between-group difference at 12 weeks \\[mean difference (MD) and 95% Confidence Interval\\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for physical activity in this sample was 1.37", 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': "Cohen's d calculated as the change from baseline to 12 weeks in both groups."}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'Activity levels (metabolic equivalent \\[MET\\]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire.', 'unitOfMeasure': 'metabolic equivalent (MET)-min/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'PTSD Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.'}, {'id': 'OG001', 'title': 'Usual Care Wait-List', 'description': 'Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '42.97', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '41.06', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '35.87', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '38.19', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'groupDescription': "The between-group difference at 12 weeks \\[mean difference (MD) and 95% Confidence Interval\\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for PCL-5 in this sample was 0.38", 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': "Cohen's d calculated as the change from baseline to 12 weeks in both groups."}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'PTSD symptom severity was assessed at both baseline and 12 Weeks using the PTSD Checklist for DSM-V (PCL-5). Scores on the PCL-5 range from 0 to 80, with higher scores indicating more severe PTSD symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aerobic Endurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.'}, {'id': 'OG001', 'title': 'Usual Care Wait-List', 'description': 'Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '462.1', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '465.9', 'spread': '32.0', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '531.1', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '476.0', 'spread': '21.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'groupDescription': "The between-group difference at 12 weeks \\[mean difference (MD) and 95% Confidence Interval\\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for 6-minute walk in this sample was 0.50", 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': "Cohen's d calculated as the change from baseline to 12 weeks in both groups."}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'Aerobic endurance was assessed using the 6-minute walk test (distance).', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants in the usual care (UC) condition did not complete this test at 12 weeks, and were not included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise', 'description': 'Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.'}, {'id': 'FG001', 'title': 'Usual Care Wait-List', 'description': 'Participants randomized to this arm continued to receive usual care services for PTSD through the Veterans Health Administration (VHA) for 12 weeks after which time they will be offered the physical activity program for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise', 'description': 'Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.'}, {'id': 'BG001', 'title': 'Usual Care Wait-List', 'description': 'Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '66.9', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '67.3', 'spread': '3.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PTSD Checklist DSM-V (PTSD symptoms)', 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '42.0', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This scale measures PTSD symptoms. Total scale range from 0 to 80, with higher scores indicating more severe PTSD symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '30.4', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '30.5', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-06', 'size': 174751, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-04T10:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2014-10-27', 'resultsFirstSubmitDate': '2019-12-10', 'studyFirstSubmitQcDate': '2014-11-17', 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-17', 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Patient Recruitment', 'timeFrame': 'Baseline', 'description': 'The primary aim/outcome of this pilot study is the feasibility of recruiting older Veterans with PTSD to participate in a 12-week exercise program. The number of Veterans recruited out of the total number contacted will be determined at baseline.'}, {'measure': 'Physical Activity', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'Activity levels (metabolic equivalent \\[MET\\]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire.'}, {'measure': 'PTSD Symptoms', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'PTSD symptom severity was assessed at both baseline and 12 Weeks using the PTSD Checklist for DSM-V (PCL-5). Scores on the PCL-5 range from 0 to 80, with higher scores indicating more severe PTSD symptoms.'}], 'secondaryOutcomes': [{'measure': 'Aerobic Endurance', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'Aerobic endurance was assessed using the 6-minute walk test (distance).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aged', 'Exercise', 'Veterans', 'Adherence', 'Clinical Trials, Randomized'], 'conditions': ['Post-traumatic']}, 'referencesModule': {'references': [{'pmid': '29632895', 'type': 'BACKGROUND', 'citation': 'Hall KS, Morey MC, Beckham JC, Bosworth HB, Pebole MM, Pieper CF, Sloane R. The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. Transl J Am Coll Sports Med. 2018 Mar 15;3(6):43-51. doi: 10.1249/TJX.0000000000000056.'}, {'pmid': '31057332', 'type': 'RESULT', 'citation': 'Pebole MM, Hall KS. Physical activity promotion in women with PTSD: What we need for progress. Psychol Sport Exerc. 2019 Mar;41:127-129.'}, {'pmid': '31264055', 'type': 'RESULT', 'citation': 'Hall KS, Morey MC, Bosworth HB, Beckham JC, Pebole MM, Sloane R, Pieper CF. Pilot randomized controlled trial of exercise training for older veterans with PTSD. J Behav Med. 2020 Aug;43(4):648-659. doi: 10.1007/s10865-019-00073-w. Epub 2019 Jul 1.'}], 'seeAlsoLinks': [{'url': 'https://www.research.va.gov/currents/0418-Older-Veterans-with-PTSD-take-part-in-exercise-program.cfm', 'label': 'Click here for more information about this study: Exercise as an Adjuvant Therapy for Veterans with PTSD'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether posttraumatic stress disorder (PTSD) symptoms impact adherence to a 12-week physical activity program and whether exercise can help improve PTSD symptoms and health outcomes in older Veterans. Veterans over the age of 60 with PTSD were be recruited to participate in a 12-week physical activity program consisting of aerobic and strengthening activities. 54 participants were randomized to an intervention arm (n=36) or usual care wait-list control (n=18).', 'detailedDescription': "There is substantial evidence that physical inactivity contributes to poorer physical health outcomes in older adults. There is a paucity of work examining physical activity in Veterans with PTSD. Consequently, the efficacy of exercise as a beneficial adjunctive therapy in the treatment for PTSD symptoms and related health sequelae has not been established. Methods: Approximately 50 Veterans 60 years and older with PTSD will be recruited to participate in a 12-week physical activity program consisting of aerobic and strength-training activities. Participants will be randomized to an intervention arm or usual care wait-list control. Outcomes: Changes in physical function, PTSD symptom severity, and aerobic endurance will be assessed between the two study arms. Summary: This pilot trial will extend the investigators' understanding of the physical and psychological benefits of physical activity in Veterans with PTSD. The results from this study will be used to be used to develop a larger, randomized controlled exercise trial for Veterans with PTSD. Once new, effective exercise therapies for Veterans with PTSD are established, we can augment traditional PTSD therapy with exercise therapy to promote the prevention and treatment of chronic diseases common in this vulnerable population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet diagnostic criteria for current PTSD,\n* live within 50 miles of Durham VA Medical Center (VAMC) and have reliable transportation,\n* registered for care at the Durham VAMC,\n* independently mobile (assistive devices acceptable),\n* speak and write fluent conversational English\n\nExclusion Criteria:\n\n* Active substance dependence other than nicotine,\n* cognitive impairment, uncontrolled psychotic symptoms,\n* clinical history of cardiovascular disease (CVD) occurring within the past 3 months,\n* uncontrolled hypertension,\n* renal disease or currently receiving dialysis,\n* psychotropic medication initiated within 6 weeks prior to enrollment\n* proliferative retinopathy'}, 'identificationModule': {'nctId': 'NCT02295995', 'briefTitle': 'Exercise and PTSD in Older Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Exercise as an Adjuvant Therapy for Veterans With PTSD', 'orgStudyIdInfo': {'id': 'D1316-W'}, 'secondaryIdInfos': [{'id': '5IK2RX001316-02', 'link': 'https://reporter.nih.gov/quickSearch/5IK2RX001316-02', 'type': 'NIH'}, {'id': '1IK2RX001316-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1IK2RX001316-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Activity', 'description': 'Participants randomized to this arm will be enrolled in a 12-week physical activity program.', 'interventionNames': ['Behavioral: Exercise as an Adjuvant Therapy for Veterans with PTSD']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Wait-List', 'description': 'Participants randomized to this arm will continue to receive usual care services for PTSD through the Veterans Health Administration (VHA) for 12 weeks after which time they will be offered the physical activity program for 12 weeks.'}], 'interventions': [{'name': 'Exercise as an Adjuvant Therapy for Veterans with PTSD', 'type': 'BEHAVIORAL', 'description': 'Methods: Approximately 50 Veterans 60 years and older with PTSD will be recruited to participate in a 12-week physical activity program consisting of aerobic and strength-training activities. Participants will be randomized to an intervention arm or usual care wait-list control. Outcomes: Changes in physical function, PTSD symptom severity, and aerobic endurance will be assessed between the two study arms. Secondary outcomes include compliance with the intervention, pain, sleep, and psychological well-being.', 'armGroupLabels': ['Physical Activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Katherine Shepherd Hall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA Medical Center, Durham, NC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}