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Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

Primary Purpose

Post-traumatic Stress Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Training

Healthy Aging Attention Control (HA-ATC)

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring Physical performance, Veterans, Aged, Exercise, HRQOL

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Veteran status
registered for care at Durham VA Health Care System (VAHCS)
live within 50 miles of fitness facility
meet diagnostic criteria for PTSD as assessed by the CAPS-5

Exclusion Criteria:

history of any psychiatric disorder with severe psychotic features in the past 5 years (e.g., bipolar disorder, mania), as indicated by ICD-10 codes F20-F29 (ICD-9 category 298.9)
prominent suicidal ideation or hospitalization for suicidality in the previous 6 months
clinically significant: neurological disorder, systemic illness affecting central nervous system (CNS) function, or history of seizure disorder in the past 5 years
uncontrolled diabetes defined as:
- Abnormal fasting plasma glucose 126 mg/dL, random plasma glucose 200 mg/dL
- no active medications for diabetes management (Metformin, insulin, etc.)
- no clinical notes in the patient's electronic health record (EHR) indicating monitoring by primary care physician (PCP) or Endo for diabetes management)
- end stage liver disease or currently receiving dialysis
- physical disabilities precluding use of exercise equipment (assistive mobility devices acceptable)
- significant cognitive impairment or diagnosis of Alzheimer's Disease or Dementia
- hospitalization or ER visit in the past 6 months for conditions contraindicated for exercise (cardiac event; physical trauma)

Sites / Locations

Durham VA Medical Center, Durham, NCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Healthy Aging Attention Control

Arm Description

Progressive, multi-component supervised exercise training group.

A health education program that addresses topics relevant to older adults.

Outcomes

Primary Outcome Measures

Clinician-Administered PTSD Scale for DSM-V (CAPS-5)

PTSD symptoms over the previous month will be assessed with the CAPS-5 clinical interview. Total symptom severity score and symptom cluster severity scores will be calculated. Scores range from 0 to 80, with higher scores reflecting more sever PTSD symptoms.

Six-minute walk test

Performance-based measure of aerobic endurance. Participants are instructed to walk along a measured course for 6 minutes. The distance walked in 6 minutes (feet) is the outcome of this assessment. There is no maximum value for this test, but the minimum value could be 0 (unable to walk any distance).

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9)

Self-report tool for assessing the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.

Pittsburgh Sleep Quality Index (PSQI)

The PSQI is a self-report tool for assessing sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with higher scores indicating poorer sleep quality.

Full Information

NCT ID

NCT04199182

First Posted

December 11, 2019

Last Updated

May 10, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT04199182

Brief Title

Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

Official Title

Exploring the Effects of Exercise Training on PTSD Symptoms and Physical Health in Older Veterans With PTSD

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 7, 2021 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Posttraumatic stress disorder (PTSD) is prevalent among military Veterans and is more than just a psychological condition; PTSD has profound negative impacts on health, function, and quality of life. Older Veterans are the largest patient population served by the Veterans Health Administration (VHA), and many have lived with PTSD for 40+ years. Veterans with PTSD engage in low levels of physical activity and spend much of their time in sedentary activities, adding to their risk of physical disability. The benefits of exercise on mental health and physical well-being in older adults are well-substantiated, but the effects of exercise training on late-life PTSD symptoms is a new area of study. This study is designed to examine the effects of 6 months of supervised exercise training on PTSD symptoms and PTSD-related conditions (e.g., functional impairment, sleep) in 188 older Veterans with PTSD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-traumatic Stress Disorder

Keywords

Physical performance, Veterans, Aged, Exercise, HRQOL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Behavioral intervention testing the effects of supervised exercise versus attention-control on PTSD symptoms and function.

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Progressive, multi-component supervised exercise training group.

Arm Title

Healthy Aging Attention Control

Arm Type

Active Comparator

Arm Description

A health education program that addresses topics relevant to older adults.

Intervention Type

Behavioral

Intervention Name(s)

Exercise Training

Intervention Description

A multi-component group exercise intervention that emphasizes functional training. Duration is 6 months, and frequency is 3x per week.

Intervention Type

Other

Intervention Name(s)

Healthy Aging Attention Control (HA-ATC)

Other Intervention Name(s)

HA-ATC

Intervention Description

Participants in the HA-ATC group will receive a health education program modeled on the "10 Keys to Healthy Aging" curriculum and the National Council on Aging's "Aging Mastery Program." HA-ATC will include an 8-week face-to-face group program followed by bi-weekly sessions for the remaining 4 months.

Primary Outcome Measure Information:

Title

Clinician-Administered PTSD Scale for DSM-V (CAPS-5)

Description

Time Frame

6 months

Title

Six-minute walk test

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Patient Health Questionnaire (PHQ-9)

Description

Self-report tool for assessing the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.

Time Frame

6 months

Title

Pittsburgh Sleep Quality Index (PSQI)

Description

The PSQI is a self-report tool for assessing sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with higher scores indicating poorer sleep quality.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Veteran status registered for care at Durham VA Health Care System (VAHCS) live within 50 miles of fitness facility meet diagnostic criteria for PTSD as assessed by the CAPS-5 Exclusion Criteria: history of any psychiatric disorder with severe psychotic features in the past 5 years (e.g., bipolar disorder, mania), as indicated by ICD-10 codes F20-F29 (ICD-9 category 298.9) prominent suicidal ideation or hospitalization for suicidality in the previous 6 months clinically significant: neurological disorder, systemic illness affecting central nervous system (CNS) function, or history of seizure disorder in the past 5 years uncontrolled diabetes defined as: Abnormal fasting plasma glucose 126 mg/dL, random plasma glucose 200 mg/dL no active medications for diabetes management (Metformin, insulin, etc.) no clinical notes in the patient's electronic health record (EHR) indicating monitoring by primary care physician (PCP) or Endo for diabetes management) end stage liver disease or currently receiving dialysis physical disabilities precluding use of exercise equipment (assistive mobility devices acceptable) significant cognitive impairment or diagnosis of Alzheimer's Disease or Dementia hospitalization or ER visit in the past 6 months for conditions contraindicated for exercise (cardiac event; physical trauma)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katherine S Hall, PhD

Phone

(919) 286-0411

Ext

176734

katherine.hall3@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katherine Shepherd Hall, PhD

Organizational Affiliation

Durham VA Medical Center, Durham, NC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Durham VA Medical Center, Durham, NC

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705-3875

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Edelman, MD MHS

Phone

(919) 286-6936

david.edelman@va.gov

First Name & Middle Initial & Last Name & Degree

Lisa J Eiben

Phone

(202) 382-2345

Lisa.Eiben@va.gov

First Name & Middle Initial & Last Name & Degree

Jean C Beckham, PhD

First Name & Middle Initial & Last Name & Degree

Katherine Shepherd Hall, PhD

First Name & Middle Initial & Last Name & Degree

Miriam C. Morey, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All of the individual participant data collected during the trial, after de-identification, will be made available. A limited dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Only de-identified (stripped of 18 HIPAA) and anonymized datasets (void of any identifying code, study or otherwise) will be shared.

IPD Sharing Time Frame

Data will be made available immediately following publication. No end date.

IPD Sharing Access Criteria

Requests for de-identified meta-data will be considered by the PI, under a data-sharing agreement that includes: 1) a commitment to using the data only for research purposes; 2) a commitment to securing data using appropriate digital technology; and 3) a commitment to destroying or returning the data after analyses are complete. Data access will be provided only to qualified researchers, with a methodologically sound proposal, fully consistent with the VA/NIH data sharing policies and applicable laws and regulations.

Learn more about this trial

Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

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