Exercise and PTSD in Older Veterans

January 17, 2020 updated by: VA Office of Research and Development

Exercise as an Adjuvant Therapy for Veterans With PTSD

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center, Durham, NC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Physical Activity
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
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.
NO_INTERVENTION: Usual Care Wait-List
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?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline and 12 Weeks
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.
Baseline and 12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Aerobic Endurance
Time Frame: Baseline and 12 Weeks
Aerobic endurance was assessed using the 6-minute walk test (distance).
Baseline and 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1316-W
  • 5IK2RX001316-02 (NIH)
  • 1IK2RX001316-01A2 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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