REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)

Covid19 Clinical Trial

— REMMHIIT-COVID  

Official title:

REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664101
• Other study ID #: Pro00105798
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)

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 (REMM-HIIT-ICU-COVID) will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, Mhealth-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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >= 18 years

2. ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory failure or infection requiring intubation and mechanical ventilation for > 48 hours with an ICU length of stay of = 4 days.

3. Ability to ambulate with or without a gait aid prior to hospital discharge

4. Expected hospital discharge directly back to patient's residence (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)

Exclusion Criteria:

1. Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)

2. Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement)

3. Unable or unwilling to follow coaching via mobile-health iPhone interaction

4. Any absolute contraindications to exercise (as outlined in the American Thoracic Society Guidelines for Cardiopulmonary Exercise Testing), including but not limited to:

1. Recent (< 5 days) acute primary cardiac event

2. Unstable Angina

3. Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise

4. Symptomatic aortic stenosis

5. Uncontrolled symptomatic heart failure

6. Acute myocarditis or pericarditis

7. Suspected or known dissecting aneurysm

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Critical Illness
• Fitness Trackers
• High Intensity Interval Training
• ICU
• Intensive Care Units

Intervention

Behavioral:
• REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) The intervention consists of high intensity interval training, consisting of a 30-minute exercise session that includes 10 x 1-minute intervals of high intensity 3x/week (e.g., Monday, Wednesday, Friday) and supplemented with 2 sessions per week of strength, balance, and mobility exercises (e.g., Tuesday, Thursday). Exercise will be supported by an activity tracker, which will allow study personnel to track patient heart rates during exercise on a daily basis, allowing them to provide individualized feedback and coaching.

Other:
• Comparator
Patients randomized to the control arm will receive the same technology platform and education on exercise options, including HIIT, but will return home to exercise as they see fit without personalized instruction and coaching. They will be remotely monitored, but will not receive feedback unless any adverse events are noted

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge	Measured by peripheral blood mononuclear cell (PBMC)	Hospital discharge (baseline), 3 months post-discharge
Other	Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge	Measured by plasma	Hospital discharge (baseline), 3 months post-discharge
Primary	Peak oxygen consumption (V02P) at 3 months after hospital discharge		3 months post-discharge
Secondary	Change in 6 minute walk test distance from baseline to 3 months after hospital discharge	distance walked in 6 minutes	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in muscle mass from baseline to 3 months after hospital discharge	Measured by muscle sound	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in muscle strength from baseline to 3 months after hospital discharge	Measured by Fried Frailty (includes Hand Grip strength)	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in muscle strength from baseline to 3 months after hospital discharge	Measured by quadriceps strength (Quadricep muscle dynamometry)	Hospital discharge (baseline), 3 months post-discharge
Secondary	Cognition at 3 months after hospital discharge	Measured by Repeatable Battery for Assessment of Neuropsychological Status (RBANS)	3 months post-discharge
Secondary	Change in cognition from baseline to 3 months after hospital discharge.	Measured by Montreal Cognitive Assessment (MOCA)	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in cognition from baseline to 3 months after hospital discharge.	Measured by Hayling Sentence Completion	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in cognition from baseline to 3 months after hospital discharge.	Measured by PROMIS Cognitive function	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in cognition from 3 months to 6 months after hospital discharge.	Measured by PROMIS Cognitive function	3 months post-discharge, 6 months post-hospital discharge
Secondary	Change in quality of life from baseline to 3 months after hospital discharge.	Measured by Sociodemographic survey	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in quality of life from baseline to 3 months after hospital discharge.	Measured by Employment Survey	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in quality of life from baseline to 3 months after hospital discharge.	Measured by EQ-5D-5L	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in quality of life from baseline to 3 months after hospital discharge.	Measured by Katz ADL/ Lawton IADL	Hospital discharge (baseline), 3 months post-discharge
Secondary	Change in quality of life from baseline to 3 months to 6 months after hospital discharge.	Measured by Sociodemographic Survey	3 months post-discharge, 6 months post-hospital discharge
Secondary	Change in quality of life from baseline to 3 months to 6 months after hospital discharge.	Measured by Employment Survey	3 months post-discharge, 6 months post-hospital discharge
Secondary	Change in quality of life from baseline to 3 months to 6 months after hospital discharge.	Measured by EQ-5D-5L	3 months post-discharge, 6 months post-hospital discharge
Secondary	Change in quality of life from baseline to 3 months to 6 months after hospital discharge.	Measured by Katz ADL/ Lawton IADL	3 months post-discharge, 6 months post-hospital discharge