Exercise and PTSD in Older Veterans

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Exercise as an Adjuvant Therapy for Veterans With PTSD

Conditions
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Post-traumatic

Intervention / Treatment
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* Behavioral: Exercise as an Adjuvant Therapy for Veterans with PTSD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet diagnostic criteria for current PTSD, live within 50 miles of Durham VA Medical Center (VAMC) and have reliable transportation, registered for care at the Durham VAMC, independently mobile (assistive devices acceptable), speak and write fluent conversational English Exclusion Criteria: Active substance dependence other than nicotine, cognitive impairment, uncontrolled psychotic symptoms, clinical history of cardiovascular disease (CVD) occurring within the past 3 months, uncontrolled hypertension, renal disease or currently receiving dialysis, psychotropic medication initiated within 6 weeks prior to enrollment proliferative retinopathy

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity<br>Participants randomized to this arm will be enrolled in a 12-week physical activity program. | Behavioral: Exercise as an Adjuvant Therapy for Veterans with PTSD<br>* 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.<br>|
| No Intervention: Usual Care Wait-List<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Patient Recruitment | 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. | Baseline | 
| Physical Activity | Activity levels (metabolic equivalent [MET]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire. | Baseline and 12 Weeks | 
| PTSD Symptoms | 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. | Baseline and 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic Endurance | Aerobic endurance was assessed using the 6-minute walk test (distance). | Baseline and 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged, Exercise, Veterans, Adherence, Clinical Trials, Randomized