Recruiting

Physical Rehabilitation

Sponsor:

Duke University

Code:

NCT05218083

Conditions

COVID-19

Critical Illness

ICU Acquired Weakness

PICS

Cardiorespiratory Fitness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT05218083

Start date

Feb 23, 2023

Status verified date

May, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT

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

no intervention: Exercise education without personalized sessions or feedback

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)

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.

Primary outcome measure

  • Change in 6 minute walk distance [ Time Frame: Baseline to 3 month follow-up ]

Central Contacts and Locations

Central contacts

Marjan Cobbaert, MPH

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

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43201

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

Duke University

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-28.