RECRUITING

REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19

Conditions

COVID-19 Critical Illness ICU Acquired Weakness PICS Cardiorespiratory Fitness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Multicenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session.

Official Title

REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19

Quick Facts

Study Start:2023-02-23

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05218083

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Primary diagnosis of COVID-19 requiring hospital admission * Discharged or expected to be discharged directly home from the hospital (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital) * Able to ambulate with or without a gait aid prior to hospital discharge * Age ≥ 18 years	* Hospital discharge \> 60 days unless readmitted to hospital in first 30 days, then 60 day window restarts and new exclusion is last hospital discharge \> 60 days * Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted) * Functional impairment resulting in inability to exercise at baseline * Inability or unwillingness to comply with the study requirements or unable or unwilling to follow coaching via mobile-health iPhone interaction * Any absolute contraindications to exercise, including but not limited to: * Recent (\< 5 days) acute primary cardiac event * Unstable Angina * Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise * Uncontrolled hypertension over 255 mmHg Systolic or 155 diastolic blood pressure * Symptomatic aortic stenosis * Uncontrolled symptomatic heart failure * Acute myocarditis or pericarditis * Suspected or known dissecting aneurysm * Any adverse changes during GXT (i.e., persistent oxygen saturation drop below 88% while on prescribed oxygen therapy or significant hypotension such as mean arterial blood pressure \< 60 mmHg on 2 consecutive readings within 1 minute) * High risk for non-adherence as determined by screening evaluation * Any condition, including cognitive impairment, that, in the judgment of the investigator, precludes participation because it could affect subject safety or ability of subject to complete the study * Pregnant

Inclusion Criteria

Exclusion Criteria

* Primary diagnosis of COVID-19 requiring hospital admission
* Discharged or expected to be discharged directly home from the hospital (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
* Able to ambulate with or without a gait aid prior to hospital discharge
* Age ≥ 18 years

* Hospital discharge \> 60 days unless readmitted to hospital in first 30 days, then 60 day window restarts and new exclusion is last hospital discharge \> 60 days
* Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
* Functional impairment resulting in inability to exercise at baseline
* Inability or unwillingness to comply with the study requirements or unable or unwilling to follow coaching via mobile-health iPhone interaction
* Any absolute contraindications to exercise, including but not limited to:
* Recent (\< 5 days) acute primary cardiac event
* Unstable Angina
* Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
* Uncontrolled hypertension over 255 mmHg Systolic or 155 diastolic blood pressure
* Symptomatic aortic stenosis
* Uncontrolled symptomatic heart failure
* Acute myocarditis or pericarditis
* Suspected or known dissecting aneurysm
* Any adverse changes during GXT (i.e., persistent oxygen saturation drop below 88% while on prescribed oxygen therapy or significant hypotension such as mean arterial blood pressure \< 60 mmHg on 2 consecutive readings within 1 minute)
* High risk for non-adherence as determined by screening evaluation
* Any condition, including cognitive impairment, that, in the judgment of the investigator, precludes participation because it could affect subject safety or ability of subject to complete the study
* Pregnant

Contacts and Locations

Study Contact

Marjan Cobbaert, MPH

CONTACT

919-668-9740

marjan.cobbaert@duke.edu

Principal Investigator

Paul Wischmeyer, MD

PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Duke University Health System

Durham, North Carolina, 27710

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43201

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: Duke University

Paul Wischmeyer, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-23

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2023-02-23

Study Completion Date2026-11-01

Terms related to this study

Additional Relevant MeSH Terms

COVID-19
Critical Illness
ICU Acquired Weakness
PICS
Cardiorespiratory Fitness