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Tele-Exercise Rehabilitation for COVID-19 Recovery (BOOST Trial)
N/A
Recruiting
Led By Alice S. Ryan, 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
Diagnosis of 2 of the following conditions: hypertension, diabetes, cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease
Diagnosis of 1 condition and BMI > 30 kg/m2
Must not have
Myocardial infarction within 3 months
End stage renal failure (dialysis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after 12 weeks tele-exercise
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate whether a home-based, supervised, group exercise tele-rehabilitation can help Veterans recovered from COVID-19 with their cardiopulmonary and physical function.
Who is the study for?
This trial is for Veterans who had COVID-19 over 90 days ago, with a BMI over 30 and at least one comorbidity like hypertension or diabetes. It's not for those with recent heart attacks, uncontrolled health issues like severe diabetes or high blood pressure, or anyone already doing regular structured exercise.
What is being tested?
The study tests a home-based group exercise program delivered through tele-rehabilitation to improve cardiopulmonary and physical function in Veterans who have recovered from COVID-19.
What are the potential side effects?
Since the intervention involves exercise, potential side effects may include muscle soreness, fatigue, and increased risk of injury. Specific risks will depend on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with at least two of the following: high blood pressure, diabetes, heart disease, kidney disease, or COPD.
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I have a diagnosed condition and my BMI is over 30.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a heart attack in the last 3 months.
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I am on dialysis for end-stage kidney failure.
Select...
I do not have severe heart failure (my heart's pumping ability is above 20% and I am not in advanced heart failure stages).
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I haven't had cancer treatment, except for skin cancer, in the last 3 months.
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My liver is in its final stage of disease and not functioning properly.
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I don't have health issues that would stop me from doing exercise tests or training.
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My diabetes is not well-controlled.
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I experience chest pain that limits my activity.
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I have leg pain from poor circulation when I walk.
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I am at high risk of falling or have had falls or fractures.
Select...
I need help to walk due to nerve issues or weakness.
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I have severe arthritis that makes it hard for me to walk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and after 12 weeks tele-exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after 12 weeks tele-exercise
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Weight Changes
Secondary study objectives
Change in 2-minute step test
chair stands
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tele-exerciseExperimental Treatment1 Intervention
Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.
Find a Location
Who is running the clinical trial?
Baltimore VA Medical CenterFED
32 Previous Clinical Trials
3,015 Total Patients Enrolled
1 Trials studying COVID-19
150 Patients Enrolled for COVID-19
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,786 Total Patients Enrolled
15 Trials studying COVID-19
748,764 Patients Enrolled for COVID-19
Baltimore Veterans Affairs Medical CenterUNKNOWN
4 Previous Clinical Trials
386 Total Patients Enrolled
1 Trials studying COVID-19
150 Patients Enrolled for COVID-19
Salem Veterans Affairs Medical CenterFED
5 Previous Clinical Trials
542 Total Patients Enrolled
Alice S. Ryan, PhDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
6 Previous Clinical Trials
651 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack in the last 3 months.I am on dialysis for end-stage kidney failure.You had COVID-19 more than 90 days ago and it was documented by a doctor.I do not have severe heart failure (my heart's pumping ability is above 20% and I am not in advanced heart failure stages).I haven't had cancer treatment, except for skin cancer, in the last 3 months.You do regular, structured aerobic exercise more than three times per week.My liver is in its final stage of disease and not functioning properly.I have been diagnosed with at least two of the following: high blood pressure, diabetes, heart disease, kidney disease, or COPD.I don't have health issues that would stop me from doing exercise tests or training.My diabetes is not well-controlled.I experience chest pain that limits my activity.I have a diagnosed condition and my BMI is over 30.Your blood pressure is too high and not under control.I have leg pain from poor circulation when I walk.You have been diagnosed with dementia.Your EKG shows signs of heart problems like blockages or abnormal heart rhythms.I am at high risk of falling or have had falls or fractures.I need help to walk due to nerve issues or weakness.I have severe arthritis that makes it hard for me to walk.I do not have severe lung problems needing home oxygen or hospital visits in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Tele-exercise
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.