Exercise and PTSD in Older Veterans

NCT ID: NCT02295995

Last Updated: 2020-01-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-18

Study Completion Date

2019-04-15

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.

Conditions

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Post-traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Physical Activity

Participants randomized to this arm will be enrolled in a 12-week physical activity program.

Group Type EXPERIMENTAL

Exercise as an Adjuvant Therapy for Veterans with PTSD

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine Shepherd Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

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Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Hall KS, Morey MC, Beckham JC, Bosworth HB, Pebole MM, Pieper CF, Sloane R. The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. Transl J Am Coll Sports Med. 2018 Mar 15;3(6):43-51. doi: 10.1249/TJX.0000000000000056.

Reference Type BACKGROUND
PMID: 29632895 (View on PubMed)

Pebole MM, Hall KS. Physical activity promotion in women with PTSD: What we need for progress. Psychol Sport Exerc. 2019 Mar;41:127-129.

Reference Type RESULT
PMID: 31057332 (View on PubMed)

Hall KS, Morey MC, Bosworth HB, Beckham JC, Pebole MM, Sloane R, Pieper CF. Pilot randomized controlled trial of exercise training for older veterans with PTSD. J Behav Med. 2020 Aug;43(4):648-659. doi: 10.1007/s10865-019-00073-w. Epub 2019 Jul 1.

Reference Type RESULT
PMID: 31264055 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Related Links

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https://www.research.va.gov/currents/0418-Older-Veterans-with-PTSD-take-part-in-exercise-program.cfm

Click here for more information about this study: Exercise as an Adjuvant Therapy for Veterans with PTSD

Other Identifiers

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5IK2RX001316-02

Identifier Type: NIH

Identifier Source: secondary_id

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1IK2RX001316-01A2

Identifier Type: NIH

Identifier Source: secondary_id

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D1316-W

Identifier Type: -

Identifier Source: org_study_id

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