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

NCT04664101 | Completed

• 1 other identifier: Pro00105798
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Covid19; Critical Illness; High Intensity Interval Training; ICU; Intensive Care Units; Fitness Trackers

Keywords

critical care; Covid19; ICU; high intensity interval training; intensive care unit; critical illness; fitness trackers

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (V02P) at 3 months after hospital discharge

  3 months post-discharge

Secondary Outcomes (17)

• Change in 6 minute walk test distance from baseline to 3 months after hospital discharge

  Hospital discharge (baseline), 3 months post-discharge

• Change in muscle mass from baseline to 3 months after hospital discharge

  Hospital discharge (baseline), 3 months post-discharge

• Change in muscle strength from baseline to 3 months after hospital discharge

  Hospital discharge (baseline), 3 months post-discharge

• Change in muscle strength from baseline to 3 months after hospital discharge

  Hospital discharge (baseline), 3 months post-discharge

• Cognition at 3 months after hospital discharge

  3 months post-discharge

Other Outcomes (2)

• Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge

  Hospital discharge (baseline), 3 months post-discharge

• Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge

  Hospital discharge (baseline), 3 months post-discharge

Study Arms (2)

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)

EXPERIMENTAL

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.

Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)

Comparator

OTHER

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

Other: Comparator

Interventions

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) BEHAVIORAL

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.

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)

Comparator OTHER

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

Comparator

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years
• 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.
• Ability to ambulate with or without a gait aid prior to hospital discharge
• Expected hospital discharge directly back to patient's residence (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)

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 hospital discharge (including need for home oxygen requirement)
• Unable or unwilling to follow coaching via mobile-health iPhone interaction
• Any absolute contraindications to exercise (as outlined in the American Thoracic Society Guidelines for Cardiopulmonary Exercise Testing), including but not limited to:
• Recent (\< 5 days) acute primary cardiac event
• Unstable Angina
• Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
• Symptomatic aortic stenosis
• Uncontrolled symptomatic heart failure
• Acute myocarditis or pericarditis
• Suspected or known dissecting aneurysm

Sponsors & Collaborators

• Duke University: lead
• Vanderbilt University: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

COVID-19; Critical Illness

Interventions

Telemedicine

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)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Paul Wischmeyer, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 11, 2020
• Study Start: March 2, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)