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Exercise Training for PTSD
N/A
Recruiting
Led By Katherine Shepherd Hall, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will study the effects of exercise on PTSD symptoms in 188 older Veterans.
Who is the study for?
This trial is for older Veterans with PTSD who are registered at Durham VAHCS, live within 50 miles of the fitness facility, and have been diagnosed with PTSD. It's not for those with end-stage liver disease, dialysis patients, significant cognitive impairments like Alzheimer's or Dementia, severe neurological disorders or seizure history in the last 5 years, certain psychiatric disorders with psychosis in the past 5 years, uncontrolled diabetes without active management, recent suicidal ideation or hospitalization for suicidality.Check my eligibility
What is being tested?
The study tests if a supervised exercise training program can improve symptoms of PTSD and related conditions such as functional impairment and sleep quality over six months. The effects will be compared to a control group receiving Healthy Aging Attention Control (HA-ATC).See study design
What are the potential side effects?
While specific side effects aren't listed for this type of intervention since it involves exercise rather than medication, participants may experience typical exercise-related discomforts such as muscle soreness or fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinician-Administered PTSD Scale for DSM-V (CAPS-5)
Six-minute walk test
Secondary outcome measures
Patient Health Questionnaire (PHQ-9)
Pittsburgh Sleep Quality Index (PSQI)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 Intervention
Progressive, multi-component supervised exercise training group.
Group II: Healthy Aging Attention ControlActive Control1 Intervention
A health education program that addresses topics relevant to older adults.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Training
2011
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,612 Previous Clinical Trials
3,305,555 Total Patients Enrolled
Katherine Shepherd Hall, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
1 Previous Clinical Trials
54 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I live within 50 miles of the fitness facility.I have been diagnosed with PTSD.I have not had serious thoughts of suicide or been hospitalized for suicidality in the last 6 months.I have not had a neurological disorder, systemic illness affecting my brain, or seizures in the last 5 years.My diabetes is not under control, with high blood sugar levels and no current treatment.I have severe liver disease or am on dialysis.I have been diagnosed with Alzheimer's Disease or Dementia, or have significant cognitive impairment.I haven't had severe mental health issues like bipolar disorder in the last 5 years.I can't use exercise equipment due to physical disabilities, but I can use assistive devices.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise
- Group 2: Healthy Aging Attention Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being accepted into this trial?
"This study, which was first advertised on June 7th 2021 and recently revised on June 10th 2022, is presently searching for participants according to clinicaltrials.gov."
Answered by AI
What is the cohort size for this research project?
"Affirmative. Clinicaltrials.gov supports the fact that this clinical experiment, originally posted on June 7th 2021, is presently looking for volunteers. Approximately 188 participants need to be recruited from 1 medical facility."
Answered by AI
Who else is applying?
What site did they apply to?
Durham VA Medical Center, Durham, NC
What portion of applicants met pre-screening criteria?
Met criteria
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