Home-Based Exercise Tele-Rehabilitation After COVID-19

Not Applicable

Recruiting

• Conditions: Post SARS-CoV2 (COVID-19)
• Interventions: Other: Tele-exercise

• Registration Number: NCT05425264
• Lead Sponsor: VA Office of Research and Development

Brief 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. 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.

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 Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-21
• Study Start: 2023-06-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-01-30
• Study Completion: 2028-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tele-exercise	Tele-exercise	Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.

Primary Outcome Measures

Name	Time	Method
Change in VO2peak	Baseline and after 12 weeks tele-exercise	physical fitness, units are ml/kg/min

Secondary Outcome Measures

Name	Time	Method
chair stands	Baseline and after 12 weeks tele-exercise	muscular strength, units are number of times
Change in 2-minute step test	Baseline and after 12 weeks tele-exercise	physical function, units are number of times

Trial Locations

Locations (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States