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Completed

NCT Number: NCT02295995

Exercise and PTSD in Older Veterans

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).

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise as an Adjuvant Therapy for Veterans with PTSD

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Aerobic Endurance

    Time frame: Baseline and 12 Weeks

    Aerobic endurance was assessed using the 6-minute walk test (distance).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Exercise as an Adjuvant Therapy for Veterans With PTSD

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Nov 20, 2014
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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