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Exercise and PTSD in Older Veterans

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ClinicalTrials.gov Identifier: NCT02295995
Recruitment Status : Completed
First Posted : November 20, 2014
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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).

Condition or disease Intervention/treatment Phase
Post-traumatic Behavioral: Exercise as an Adjuvant Therapy for Veterans with PTSD Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise as an Adjuvant Therapy for Veterans With PTSD
Actual Study Start Date : December 18, 2015
Actual Primary Completion Date : May 8, 2018
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Aerobic Endurance [ Time Frame: Baseline and 12 Weeks ]
    Aerobic endurance was assessed using the 6-minute walk test (distance).


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295995


Locations
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United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Katherine Shepherd Hall, PhD Durham VA Medical Center, Durham, NC
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol and Statistical Analysis Plan  [PDF] August 6, 2019

More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02295995    
Other Study ID Numbers: D1316-W
5IK2RX001316-02 ( U.S. NIH Grant/Contract )
1IK2RX001316-01A2 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2014    Key Record Dates
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Aged
Exercise
Veterans
Adherence
Clinical Trials, Randomized