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

Not Applicable

Recruiting

• Conditions: Cardiorespiratory Fitness; PICS; COVID-19; Critical Illness; ICU Acquired Weakness
• Interventions: Behavioral: REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)

• Registration Number: NCT05218083
• Lead Sponsor: Duke University

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.

Detailed Description

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) to improve recovery after hospital discharge in patients with COVID-19 will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, mobile health-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with COVID-19 and have been discharged home from the hospital.

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-01
• Study Start: 2023-02-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-08-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in 6 minute walk distance	Baseline to 3 month follow-up	distance walked in m

Secondary Outcome Measures

Name	Time	Method
Change in physical function measured by Short Physical Performance Battery (SPPB) score.	Baseline to 3 month follow-up	Scores range from 0 (frailty) to 12 (robustness).
Change in 30-sec sit to stand score	Baseline to 3 month follow-up	Number of times the patient comes to a full standing position in 30 seconds
Change in Fried Frailty Index Score	Baseline to 3 month follow-up	Score ranges from 0 (not frail) to 5 (frail).
Change in cognitive ability as measured by the MoCA Test	Baseline to 3 months follow-up	Scores range from 0 to 30 with a lower score indicating more cognitive impairment.
Change in muscle mass obtained via MuscleSound	Baseline to 3 month follow-up	Change in IMAT index as measured by MuscleSound
Change in EQ-5D-5L Score	Baseline to 6 month follow-up	Scores range from -0.59 to 1. 1 is the best possible health state. Negative values represent health states perceived as worse than death, which is equal to 0
Change in Duke Activity Status Index (DASI) Score	Baseline to 6 month follow-up	DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity.
Change in and Lawton Score	Baseline to 6 month follow-up	Score ranges from 0 (very dependent) to 8 (high function, independent)
Change in Hospital Anxiety and Depression Scale (HADS) Scores	Baseline to 6 month follow-up	Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety
Change in Cardiorespiratory fitness	Baseline to 3 month follow-up	VO2P obtained during incremental Step Test
Compare social determinants of health between intervention and control group	6 months	Completion of the Accountable Health Communities Health-Related Social Needs Screening Tool. A higher score indicates a higher Health-related social need.

Trial Locations

Locations (4)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States