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| ID | Type | Description | Link |
|---|---|---|---|
| RX003120 | Other Grant/Funding Number | VAORD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Progressive, multi-component supervised exercise training group. |
|
| Healthy Aging Attention Control | Active Comparator | A health education program that addresses topics relevant to older adults. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training | Behavioral | A multi-component group exercise intervention that emphasizes functional training. Duration is 6 months, and frequency is 3x per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-V (CAPS-5) Change Baseline to 6 Months | 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 severe PTSD symptoms. | 6 months |
| Six-minute Walk Test Change From Baseline to 6 Months | Performance-based measure of aerobic endurance. Participants are instructed to walk along a measured course for 6 minutes. The distance walked in 6 minutes 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) Change From Baseline to 6 Months | Self-report tool for assessing the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. | 6 months |
| Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to 6 Months |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Shepherd Hall, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
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.
Data will be made available immediately following publication. No end date.
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.
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The participants are explained the nature, purpose, and procedure of the study and asked to sign an informed consent that will explain the potential risks and benefits of the study participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | Progressive, multi-component supervised exercise training group. |
| FG001 | Healthy Aging Attention Control | A health education program that addresses topics relevant to older adults. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | Progressive, multi-component supervised exercise training group. |
| BG001 | Healthy Aging Attention Control | A health education program that addresses topics relevant to older adults. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinician-Administered PTSD Scale for DSM-V (CAPS-5) Change Baseline to 6 Months | 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 severe PTSD symptoms. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
Enrollment until end of follow-up (6 months)
When participants disclosed suicidal ideation on the PHQ-9 survey, the research team conducted our risk-assessment protocol to determine appropriate steps for responding and supporting participants. Some participants reported physical health symptoms during research exercise session prompting in-depth assessment by research team and follow-up with care team as indicated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | Progressive, multi-component supervised exercise training group. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant endorsed suicidal ideation on PHQ-9 survey during baseline or follow-up assessment. | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Hall | Durham VA HCS | 9192860411 | 176734 | katherine.hall3@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2023 | Feb 9, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 4, 2023 | Nov 6, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Behavioral intervention testing the effects of supervised exercise versus attention-control on PTSD symptoms and function.
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| Healthy Aging Attention Control (HA-ATC) | Other | 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. |
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|
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. |
| 6 months |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Clinician-Administered PTSD Scale for DSM-V (CAPS-5) | Scores range from 0 to 80, with higher scores reflecting more severe PTSD symptoms. | Mean | Standard Deviation | units on a scale |
|
| Pittsburgh Sleep Quality Index (PSQI) | Scores on the PSQI range from 0 to 21, with higher scores indicating poorer sleep quality. | Mean | Standard Deviation | units on a scale |
|
| Six-minute walk test | Distance walked in 6 minutes | Mean | Standard Deviation | Meters |
|
| Patient Health Questionnaire (PHQ-9) | Depressive symptoms, total score (0-27). Higher scores denote greater depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Six-minute Walk Test Change From Baseline to 6 Months | Performance-based measure of aerobic endurance. Participants are instructed to walk along a measured course for 6 minutes. The distance walked in 6 minutes 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). | 10 participants (n=2 Exercise; n=8 HAC) did not complete the 6-minute walk test at post-test and were not included in this analysis. | Posted | Mean | Standard Deviation | Meters | 6 months |
|
|
|
| Secondary | Patient Health Questionnaire (PHQ-9) Change From Baseline to 6 Months | Self-report tool for assessing the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. | 7 participants (n=5 Exercise; n=2 HAC) did not have complete data for the PHQ-9 at post-test and were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to 6 Months | 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. | 13 participants (n=7 Exercise; n=6 HAC) did not have complete data for the PSQI at post-test and were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| 41 |
| 0 |
| 41 |
| 14 |
| 41 |
| EG001 | Healthy Aging Attention Control | A health education program that addresses topics relevant to older adults. | 0 | 39 | 0 | 39 | 6 | 39 |
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment | Participant with diabetes presented to research exercise session with BG>250 mg/dL; not permitted to exercise. Participant's care team was alerted and followed up for chronic disease mgmt. |
|
| Lightheadedness during exercise | General disorders | Non-systematic Assessment | Participant reported feeling lightheaded and nauseous during exercise session. Research team assessed vital signs, all of which were in normal limits. Provided participant with water and a snack, reported cessation of all symptoms within 10 minutes. |
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