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Exercise Training for HIV/AIDS (FIT-VET Trial)
N/A
Recruiting
Led By Kris Ann K Oursler, MD
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
Veteran living with HIV and under care at VAMC
50 years of age and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
FIT-VET Trial Summary
This trial will test a circuit exercise program that can be done over video call, to see if it can help HIV+ Veterans aged 50+ stay fit and independent.
Who is the study for?
This trial is for Veterans over 50 living with HIV, under care at VAMC, on stable antiretroviral therapy, and have a low viral load. It's not for those who already exercise regularly or have severe health issues like uncontrolled diabetes, recent heart attacks, certain lung diseases, dementia, or are on specific medications that affect exercise.Check my eligibility
What is being tested?
The study tests a circuit exercise program designed to slow aging in Veterans with HIV. The exercises don't need special equipment and are delivered via video teleconferencing (VTEL), aiming to improve life-long fitness and independence without going to a facility.See study design
What are the potential side effects?
Since the intervention involves physical exercise training through telehealth sessions, potential side effects may include typical workout-related issues such as muscle soreness or strain. However, the program is tailored to avoid major risks.
FIT-VET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran with HIV receiving care at a Veterans Affairs Medical Center.
Select...
I am 50 years old or older.
FIT-VET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline VO2peak to after 12-week exercise intervention
Secondary outcome measures
Change from Baseline DNA Methylation to after 12-week exercise intervention
Other outcome measures
VTEL Exercise Training Feasibility
FIT-VET Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: exercise groupExperimental Treatment1 Intervention
High-intensity circuit exercise training will be performed 3 times weekly for 12 weeks in a group setting. Circuit training is an exercise modality consisting of a series of exercises at different stations. Exercise training will be delivered by VTEL broadcast from the Salem VAMC to participants at the Atlanta VAMC and Baltimore VAMC. Rooms will be equipped with steps, hand and ankle weights, dumbbells, chairs and bands. No stationary exercise equipment will be used in either AEX or RT.
Group II: control groupActive Control1 Intervention
Sedentary activity (confirmed at eligibility no more than 1 structured physical activity/week) will be continued in participants randomized to the control group. Participants have the option after 12-week intervention phase to enter ?delayed? exercise training to assure that all participants can receive exercise training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
exercise training
2012
Completed Phase 4
~1120
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,204 Total Patients Enrolled
Baltimore VA Medical CenterFED
32 Previous Clinical Trials
3,045 Total Patients Enrolled
Atlanta VA Medical CenterFED
26 Previous Clinical Trials
69,355 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on dialysis for chronic kidney failure.I have severe lung problems needing home oxygen or hospital visits in the last month.I have not used steroids or growth hormones in the last 6 months.I have no health issues that prevent me from doing exercise tests or training.I am a veteran with HIV receiving care at a Veterans Affairs Medical Center.I have not been treated for any cancer except skin cancer in the last 3 months.I am 50 years old or older.I have been on the same HIV medication for at least 3 months.I have not had a heart attack in the last 3 months.I have leg pain from poor blood flow when I walk.My liver is in its final stage of illness and not functioning properly.Your blood pressure is very high and not well controlled.My diabetes has been poorly controlled in the last month.I experience chest pain that limits my activity.I have severe heart failure.I have taken beta blockers or calcium channel blockers in the last month.I have COPD or emphysema and struggle with severe breathlessness.I have not had an AIDS defining illness in the last 6 months.You have a condition called dementia, which affects your memory and thinking abilities.I need help to walk due to a neurological condition.I have severe arthritis that makes it hard for me to walk.You have been regularly doing structured aerobic exercise more than three times a week within the past month.
Research Study Groups:
This trial has the following groups:- Group 1: exercise group
- Group 2: control group
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 there still openings for this research project?
"Affirmative. Clinicaltrials.gov indicates that this investigation is currently enrolling 80 individuals from 3 sites, having initially been posted on March 10th 2020 and last modified on February 15th 2022."
Answered by AI
What is the magnitude of individuals engaged in this experiment?
"This medical trial necessitates 80 patients meeting the inclusion requirements. Participants may come from multiple locations such as Baltimore VA Medical Center VA Maryland Health Care System, located in Baltimore, MD and Salem VA Medical Center located in Salem, Virginia."
Answered by AI
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