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Clinical Trials/NCT02295995
NCT02295995
Completed
Not Applicable

Exercise as an Adjuvant Therapy for Veterans With PTSD

VA Office of Research and Development1 site in 1 country54 target enrollmentDecember 18, 2015
ConditionsPost-traumatic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-traumatic
Sponsor
VA Office of Research and Development
Enrollment
54
Locations
1
Primary Endpoint
Physical Activity
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 18, 2015
End Date
April 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Physical Activity

Time Frame: Baseline and 12 Weeks

Activity levels (metabolic equivalent \[MET\]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire.

Feasibility of Patient Recruitment

Time Frame: Baseline

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.

PTSD Symptoms

Time Frame: Baseline and 12 Weeks

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.

Secondary Outcomes

  • Aerobic Endurance(Baseline and 12 Weeks)

Study Sites (1)

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