- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05425264
Home-Based Exercise Tele-Rehabilitation After COVID-19 (BOOST)
November 5, 2025 updated by: VA Office of Research and Development
Home-Based Exercise Tele-Rehabilitation in High-Risk Veterans: Impact of COVID-19 Exposure and Socioeconomic Factors
The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in catastrophic infections and fatalities across the nation.
Many older Veterans with comorbidities are especially vulnerable to complications and poor recovery.
This award will investigate the effect of a novel, home-based, supervised, group exercise tele-rehabilitation in Veterans recovered from COVID-19 on cardiopulmonary and physical function.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
There is an urgent need to understand the lasting impact of COVID-19 on the cardiopulmonary system to improve physical function and prevent long-lasting disability.
Pertinent knowledge gaps regarding the post-recovery physiology driving any impairments need to be addressed to improve the quality of life in Veterans with prior SARS-CoV-2 infection.
Further, it is important to devise successful rehabilitation strategies that can be safely conducted in a Veteran's home.
Hence, the investigators propose to utilize VA Video Connect to deliver a home based, supervised group exercise program to Veteran COVID-19 survivors.
The objective of this exercise trial is to determine the influence of COVID-19 on cardiorespiratory fitness, pulmonary and physical function and to investigate the effect of a home-based exercise tele-rehabilitation on these outcomes.
The study design includes rural and urban sites and investigators with a history of VA rehabilitation collaboration.
Moreover, the investigators will explore healthcare disparities related to COVID-19 which are associated with functional decline and may affect sustainability of exercise rehabilitation strategies deployed, if necessary, under social distancing restrictions.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alice S Ryan, PhD
- Phone Number: (410) 605-7851
- Email: Alice.Ryan@va.gov
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
Principal Investigator:
- Alice S. Ryan, PhD
-
Contact:
- Kristina Marcus, MS
- Phone Number: (410) 605-7000
- Email: kristina.marcus@va.gov
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Veteran
- documented COVID-19 > 90 days ago
- diagnosis of 2 of following conditions: hypertension, diabetes, cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease OR 1 condition and BMI > 30 kg/m2
Exclusion Criteria:
- myocardial infarction (within 3 months)
- exertional or unstable angina (chest pain that limits activity)
- severe congestive heart failure (EF < 20% in last year or NYHA Classification III or IV)
- uncontrolled hypertension (SBP >180 &/or DBP > 110 mm Hg at screening)
- screening EKG with ischemia, complex arrhythmia, or high-grade block (per Minnesota Code)
- poorly controlled diabetes mellitus (FBS>200 mg/dl, RBS > 299 mg/dl, or HbA1C > 10)
- treatment for cancer except skin cancer (within 3 months)
- peripheral vascular disease with claudication
- severe arthritis limiting ambulation
- neurologic disease limiting ambulation (weakness requiring assist device; severe neuropathy)
- end stage liver disease (decompensated liver disease)
- End stage renal failure (dialysis)
- severe pulmonary disease (home O2, admission for dyspnea or pneumonia within 1 month)
- high fall risk (history of falls, bone fracture)
- dementia (based on Evaluation to Consent)
- signs or symptoms of any medical comorbidity that would preclude exercise testing or training
- exercises on routine basis (structured aerobic exercise > 3 time per week)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tele-exercise
Exercise training 2x/week at home.
Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.
|
Exercise training 2x/week at home.
Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in VO2peak
Time Frame: Baseline and after 12 weeks tele-exercise
|
physical fitness, units are ml/kg/min
|
Baseline and after 12 weeks tele-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 2-minute step test
Time Frame: Baseline and after 12 weeks tele-exercise
|
physical function, units are number of times
|
Baseline and after 12 weeks tele-exercise
|
|
chair stands
Time Frame: Baseline and after 12 weeks tele-exercise
|
muscular strength, units are number of times
|
Baseline and after 12 weeks tele-exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2023
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
January 30, 2028
Study Registration Dates
First Submitted
June 16, 2022
First Submitted That Met QC Criteria
June 16, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Estimated)
November 7, 2025
Last Update Submitted That Met QC Criteria
November 5, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F3639-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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