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Clinical Trials/NCT05425264
NCT05425264
Recruiting
Not Applicable

Home-Based Exercise Tele-Rehabilitation in High-Risk Veterans: Impact of COVID-19 Exposure and Socioeconomic Factors

VA Office of Research and Development1 site in 1 country80 target enrollmentJune 29, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post SARS-CoV2 (COVID-19)
Sponsor
VA Office of Research and Development
Enrollment
80
Locations
1
Primary Endpoint
Change in VO2peak
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 29, 2023
End Date
January 30, 2028
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Change in VO2peak

Time Frame: Baseline and after 12 weeks tele-exercise

physical fitness, units are ml/kg/min

Secondary Outcomes

  • chair stands(Baseline and after 12 weeks tele-exercise)
  • Change in 2-minute step test(Baseline and after 12 weeks tele-exercise)

Study Sites (1)

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