Post SARS-CoV2 (COVID-19)BOOSTNCT05425264
Home-Based Exercise Tele-Rehabilitation After COVID-19
A study testing Tele-exercise in people with Post SARS-CoV2 (COVID-19), run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Post SARS-CoV2 (COVID-19)
- What is being tested?
- Tele-exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2023to 30 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Kristina Marcus, MS, (410) 605-7000, kristina.marcus@va.gov
Alice S. Ryan, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Post SARS-CoV2 (COVID-19)
- Being tested
- Tele-exercise
- Keywords
- Exercise, COVID-19, Cardiopulmonary
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-exerciseOther
Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.
| Study group | Role | What they receive |
|---|---|---|
| Tele-exercise | Experimental | Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely. Receives: Other: Tele-exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2peak
physical fitness, units are ml/kg/min
Measured: Baseline and after 12 weeks tele-exercise
Secondary outcomes (2)
Change in 2-minute step test
physical function, units are number of times
Measured: Baseline and after 12 weeks tele-exercise
chair stands
muscular strength, units are number of times
Measured: Baseline and after 12 weeks tele-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start29 Jun 2023
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post SARS-CoV2 (COVID-19)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exercise tele-rehabilitation
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Baltimore VA Medical Center, Salem Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Alice S. Ryan, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425264
- Sponsor's protocol ID
- F3639-R
- Acronym
- BOOST
- Status last verified
- Nov 2025
- First submitted
- 16 Jun 2022
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No