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Home-Based Exercise Tele-Rehabilitation After COVID-19 (BOOST)

Primary Purpose

Post SARS-CoV2 (COVID-19)

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tele-exercise

About this trial

This is an interventional treatment trial for Post SARS-CoV2 (COVID-19) focused on measuring Exercise, COVID-19, Cardiopulmonary

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tele-exercise

Arm Description

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

Outcomes

Primary Outcome Measures

Change in VO2peak

physical fitness, units are ml/kg/min

Secondary Outcome Measures

Change in 2-minute step test

physical function, units are number of times

chair stands

muscular strength, units are number of times

Full Information

NCT ID

NCT05425264

First Posted

June 16, 2022

Last Updated

June 30, 2023

Sponsor

VA Office of Research and Development

Collaborators

Baltimore VA Medical Center, Salem Veterans Affairs Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05425264

Brief Title

Home-Based Exercise Tele-Rehabilitation After COVID-19

Acronym

BOOST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 29, 2023 (Actual)

Primary Completion Date

January 30, 2027 (Anticipated)

Study Completion Date

January 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

Collaborators

Baltimore VA Medical Center, Salem Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post SARS-CoV2 (COVID-19)

Keywords

Exercise, COVID-19, Cardiopulmonary

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Exercise tele-rehabilitation

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tele-exercise

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Tele-exercise

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in VO2peak

Description

physical fitness, units are ml/kg/min

Time Frame

Baseline and after 12 weeks tele-exercise

Secondary Outcome Measure Information:

Title

Change in 2-minute step test

Description

physical function, units are number of times

Time Frame

Baseline and after 12 weeks tele-exercise

Title

chair stands

Description

muscular strength, units are number of times

Time Frame

Baseline and after 12 weeks tele-exercise

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alice S Ryan, PhD

Phone

(410) 605-7851

Alice.Ryan@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alice S. Ryan, PhD

Organizational Affiliation

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristina Marcus, MS

Phone

410-605-7000

kristina.marcus@va.gov

First Name & Middle Initial & Last Name & Degree

Alice S. Ryan, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Home-Based Exercise Tele-Rehabilitation After COVID-19

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