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Clinical Trials/NCT05425264
NCT05425264RecruitingNot Applicable

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

VA Office of Research and Development2 sites in 1 country80 target enrollmentStarted: June 29, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
80
Locations
2
Primary Endpoint
Change in VO2peak

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)
  • 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)

Arms & Interventions

Tele-exercise

Experimental

Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.

Intervention: Tele-exercise (Other)

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)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (2)

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