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REMM-HIIT for Post-COVID-19 Critical Illness (REMMHIIT-COVID Trial)

N/A
Waitlist Available
Led By Paul Wischmeyer, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-discharge, 6 months post-hospital discharge
Awards & highlights

Summary

This trial is testing the feasibility of a new rehabilitation program for people who have been critically ill with COVID-19. The program uses high intensity interval training, which is a type of exercise that involves short bursts of very intense activity, followed by a brief rest period. The program will be remotely monitored and supported by mobile health technology.

Eligible Conditions
  • Coronavirus
  • Intensive Care Unit
  • Fitness Trackers
  • High Intensity Interval Training
  • Critical Illness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-discharge, 6 months post-hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-discharge, 6 months post-hospital discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak oxygen consumption (V02P) at 3 months after hospital discharge
Secondary outcome measures
Change in 6 minute walk test distance from baseline to 3 months after hospital discharge
Change in cognition from 3 months to 6 months after hospital discharge.
Change in cognition from baseline to 3 months after hospital discharge.
+5 more
Other outcome measures
Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge

Trial Design

2Treatment groups
Experimental Treatment
Group I: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)Experimental Treatment1 Intervention
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.
Group II: ComparatorExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)
2022
N/A
~20

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,473 Total Patients Enrolled
Vanderbilt UniversityOTHER
707 Previous Clinical Trials
6,143,520 Total Patients Enrolled
Paul Wischmeyer, MDPrincipal InvestigatorDuke University
5 Previous Clinical Trials
521 Total Patients Enrolled

Media Library

Coronavirus Research Study Groups: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT), Comparator
Coronavirus Clinical Trial 2023: REMotely Monitored, Mobile Health-Supported High Intensity Interval Training Highlights & Side Effects. Trial Name: NCT04664101 — N/A
REMotely Monitored, Mobile Health-Supported High Intensity Interval Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04664101 — N/A
~4 spots leftby Jul 2025