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

NCT05218083 | Recruiting DMC

• 2 other identifiers: Pro001096441R01HD107103
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

COVID-19; Critical Illness; ICU Acquired Weakness; PICS; Cardiorespiratory Fitness

Outcome Measures

Primary Outcomes (1)

• Change in 6 minute walk distance

  distance walked in m

  Baseline to 3 month follow-up

Secondary Outcomes (20)

• Change in Cardiorespiratory fitness

  Baseline to 3 month follow-up

• Change in physical function measured by Short Physical Performance Battery (SPPB) score.

  Baseline to 3 month follow-up

• Change in 30-sec sit to stand score

  Baseline to 3 month follow-up

• Change in Fried Frailty Index Score

  Baseline to 3 month follow-up

• Change in cognitive ability as measured by the MoCA Test

  Baseline to 3 months follow-up

Study Arms (2)

REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT

EXPERIMENTAL

Patients will receive our REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training Program (REMM-HIIT) with iWatch/iPhone.

Behavioral: REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)

Exercise education without personalized sessions or feedback

NO INTERVENTION

Patients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching.

Interventions

REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT) BEHAVIORAL

REmotely Monitored, Mobile health-supported, High Intensity Interval Training consists of remotely monitored tailored, structured, progressive multidomain physical rehabilitation \& personalized instruction \& coaching. Patients complete 3 structured exercise sessions/week consisting of HIIT, strength, balance, and mobility exercises. Following warmup, patients increase workload at a heart rate corresponding to 95% VO2peak for 1-minute before returning to warm-up speed for 1-minute at a heart rate corresponding to 60% VO2peak. Strength includes functional strengthening exercises for lower extremities \& general resistance exercises for major muscle groups. Balance incorporates static \& dynamic exercises, including progressively narrowing base of support with eyes open or closed, reaching forward \& backward starting within base of support \& progressing to outside base of support. Mobility rehabilitation includes dynamic start/stop while walking and changing direction while walking.

REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: collaborator
• University of Kentucky: collaborator
• University of Alabama at Birmingham: collaborator
• Florida Atlantic University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Duke University: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43201, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

COVID-19; Critical Illness

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paul Wischmeyer, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjan Cobbaert, MPH

CONTACT

919-668-9740; marjan.cobbaert@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 1, 2022
• Study Start: February 23, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)