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REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19 (REMM-HIIT-CoV)

Primary Purpose

COVID-19, Critical Illness, ICU Acquired Weakness

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory failure or infection requiring treatment with noninvasive ventilation (i.e., BiPap), High Flow Nasal Cannula O2, or Invasive mechanical ventilation for ≥ 48 hours with an ICU length of stay of ≥ 4 days.
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:

Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement)
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 screening 6IST (i.e., persistent oxygen saturation drop below 88-90% 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
Anticipated hospital discharge before baseline study measures could be completed
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

Sites / Locations

University of Alabama at BirminghamRecruiting
Duke University Health System
The Ohio State University Wexner Medical CenterRecruiting
Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT

Exercise education without personalized sessions or feedback

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Cardiorespiratory fitness

VO2P obtained during incremental Step Test

Secondary Outcome Measures

Change in 6 minute walk distance

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

Scores range from 0 (frailty) to 12 (robustness).

Change in 30-sec sit to stand score

Change in Fried Frailty Index Score

Score ranges from 0 (not frail) to 5 (frail).

Change in cognitive ability as measured by the MoCA Test

Scores range from 0 to 30 with a lower score indicating more cognitive impairment.

Cognitive ability as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Scores range from 40 to 160 with a lower score indicating more cognitive impairment.

Change in muscle mass obtained via MuscleSound

Diet by the GLIM criteria

Change in EQ-5D-5L Score

Scores range from -0.224 to 1, with 0, 1, and negative values corresponding to death, full health, and health states worse than death, respectively.

Change in Duke Activity Status Index (DASI) Score

DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity.

Change in PCL-5 Score

DASI scores range from 0 to 80, with a higher score indicating higher severity of PTSD symptoms.

Compare cognitive ability as measured by PROMIS

Measured by PROMIS Cognitive function

Fatigue as measured by PROMIS

Measured by PROMIS Fatigue questionnaire

Physical function as measured by PROMIS

Measured by PROMIS Physical Function questionnaire

Emotional support as measured by PROMIS

Measured by PROMIS emotional support questionnaire

Social isolation as measured by PROMIS

Measured by PROMIS social isolation questionnaire

Change in and Lawton Score

Score ranges from 0 (very dependent) to 8 (high function, independent)

Change in Katz Score

Score ranges from 0 (very dependent) to 6 (independent)

Quality of life as measured by Social determinants of health (SDOH) survey

Change in IES-R

Score ranges from 0 to 88, with a higher score indicating more affect of routine life stress, everyday traumas and acute stress

Change in Hospital Anxiety and Depression Scale (HADS) Scores

Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety

Change in Posttraumatic Stress Disorder Checklist Score (PLC-5)

Score ranges from 0 to 80, with a higher score indicating more PTSD symptoms.

Change in diet as measured by Diet History Questionnaire (DHQIII)

Quality of life as assessed by measured by financial assessment based on the FACIT COST assessment

Score ranges from 0 to 44 with a lower score indicating worse financial toxicity.

Full Information

NCT ID

NCT05218083

First Posted

January 6, 2022

Last Updated

August 17, 2023

Sponsor

Duke University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Vanderbilt University Medical Center, Ohio State University, University of Kentucky, University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT05218083

Brief Title

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

Acronym

REMM-HIIT-CoV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 23, 2023 (Actual)

Primary Completion Date

January 1, 2026 (Anticipated)

Study Completion Date

March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 Intensive Care Unit (ICU) 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.

6. Conditions and Keywords

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

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT

Arm Type

Experimental

Arm Description

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

Arm Title

Exercise education without personalized sessions or feedback

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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 Information:

Title

Change in Cardiorespiratory fitness

Description

VO2P obtained during incremental Step Test

Time Frame

Baseline to 3 month follow-up

Secondary Outcome Measure Information:

Title

Change in 6 minute walk distance

Time Frame

Baseline to 3 month follow-up

Title

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

Description

Scores range from 0 (frailty) to 12 (robustness).

Time Frame

Baseline to 3 month follow-up

Title

Change in 30-sec sit to stand score

Time Frame

Baseline to 3 month follow-up

Title

Change in Fried Frailty Index Score

Description

Score ranges from 0 (not frail) to 5 (frail).

Time Frame

Baseline to 3 month follow-up

Title

Change in cognitive ability as measured by the MoCA Test

Description

Scores range from 0 to 30 with a lower score indicating more cognitive impairment.

Time Frame

Baseline to 3 months follow-up

Title

Cognitive ability as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Description

Scores range from 40 to 160 with a lower score indicating more cognitive impairment.

Time Frame

6 month follow-up

Title

Change in muscle mass obtained via MuscleSound

Time Frame

Baseline to 3 month follow-up

Title

Diet by the GLIM criteria

Time Frame

6 month follow-up

Title

Change in EQ-5D-5L Score

Description

Scores range from -0.224 to 1, with 0, 1, and negative values corresponding to death, full health, and health states worse than death, respectively.

Time Frame

Baseline to 6 month follow-up

Title

Change in Duke Activity Status Index (DASI) Score

Description

DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity.

Time Frame

Baseline to 6 month follow-up

Title

Change in PCL-5 Score

Description

DASI scores range from 0 to 80, with a higher score indicating higher severity of PTSD symptoms.

Time Frame

Baseline to 6 month follow-up

Title

Compare cognitive ability as measured by PROMIS

Description

Measured by PROMIS Cognitive function

Time Frame

6 month follow-up

Title

Fatigue as measured by PROMIS

Description

Measured by PROMIS Fatigue questionnaire

Time Frame

6 month follow-up

Title

Physical function as measured by PROMIS

Description

Measured by PROMIS Physical Function questionnaire

Time Frame

6 month follow-up

Title

Emotional support as measured by PROMIS

Description

Measured by PROMIS emotional support questionnaire

Time Frame

6 month follow-up

Title

Social isolation as measured by PROMIS

Description

Measured by PROMIS social isolation questionnaire

Time Frame

6 month follow-up

Title

Change in and Lawton Score

Description

Score ranges from 0 (very dependent) to 8 (high function, independent)

Time Frame

Baseline to 6 month follow-up

Title

Change in Katz Score

Description

Score ranges from 0 (very dependent) to 6 (independent)

Time Frame

Baseline to 6 month follow-up

Title

Quality of life as measured by Social determinants of health (SDOH) survey

Time Frame

6 month follow-up

Title

Change in IES-R

Description

Score ranges from 0 to 88, with a higher score indicating more affect of routine life stress, everyday traumas and acute stress

Time Frame

Baseline to 6 month follow-up

Title

Change in Hospital Anxiety and Depression Scale (HADS) Scores

Description

Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety

Time Frame

Baseline to 6 month follow-up

Title

Change in Posttraumatic Stress Disorder Checklist Score (PLC-5)

Description

Score ranges from 0 to 80, with a higher score indicating more PTSD symptoms.

Time Frame

Baseline to 6 month follow-up

Title

Change in diet as measured by Diet History Questionnaire (DHQIII)

Time Frame

6 month follow-up

Title

Quality of life as assessed by measured by financial assessment based on the FACIT COST assessment

Description

Score ranges from 0 to 44 with a lower score indicating worse financial toxicity.

Time Frame

6 month follow-up

Other Pre-specified Outcome Measures:

Title

Change in mitochondrial function

Description

blood collection

Time Frame

Baseline and 6 months post-hospital discharge

Title

Change in biomarkers of inflammation

Description

blood collection

Time Frame

Baseline and 6 months post-hospital discharge

Title

Change in biomarkers of aging

Description

blood collection

Time Frame

Baseline and 6 months post-hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 > 30 days Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted) Functional impairment resulting in inability to exercise at baseline (including need for home oxygen requirement) 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 screening 6IST (i.e., persistent oxygen saturation drop below 88-90% 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 Anticipated hospital discharge before baseline study measures could be completed 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

Central Contact Person:

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

Marjan Cobbaert, MPH

Phone

919-668-9740

marjan.cobbaert@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Wischmeyer, MD

Organizational Affiliation

Duke Clinical Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Morris, MD

Facility Name

Duke University Health System

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amy Pastva, PT, PhD

Facility Name

The Ohio State University Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathan Brummel, MD

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

E Wesley Ely, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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