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Behavioural Intervention

Remote High-Intensity Interval Training for COVID-19 Recovery (REMM-HIIT-CoV Trial)

N/A

Recruiting

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

Age ≥ 18 years

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)

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ways to help people who were critically ill with COVID-19 regain physical strength.

Who is the study for?

This trial is for adults over 18 who were hospitalized with COVID-19 and can walk on their own or with a cane. They should be going home directly from the hospital, not to another care facility, and must be able to exercise and use an iPhone for mobile health coaching.

What is being tested?

The study tests a remote, mobile health-supported rehab program with high-intensity interval training (REMM-HIIT) in patients recovering from severe COVID-19. It's a randomized controlled trial involving 120 participants who complete at least one exercise session.

What are the potential side effects?

While specific side effects are not listed, high-intensity interval training may cause muscle soreness, fatigue, or exacerbate underlying conditions if present. Participants will likely be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I will be going home directly after my hospital discharge.

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I can walk by myself or with help like a cane before leaving the hospital.

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I was hospitalized due to COVID-19.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was not walking on my own before getting COVID-19, but I could use a walking aid.

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I need home oxygen or can't exercise due to my health condition.

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I do not have any health conditions that prevent me from exercising safely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 6 minute walk distance

Secondary study objectives

Change in 30-sec sit to stand score

Change in Cardiorespiratory fitness

Change in Duke Activity Status Index (DASI) Score

+8 more

Other study objectives

Change in biomarkers of aging

Change in biomarkers of inflammation

DNA, Mitochondrial

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIITExperimental Treatment1 Intervention

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

Group II: Exercise education without personalized sessions or feedbackActive Control1 Intervention

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

0 / 7Eligibility criteria met