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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Duke University
Study ID
NCT05218083
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 23, 2023
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT
    Patients will receive our REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training Program (REMM-HIIT) with iWatch/iPhone.
  • No Intervention: Exercise education without personalized sessions or feedback
    Patients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching.

Primary Outcome Measure

Change in 6 minute walk distance [ Time Frame: Baseline to 3 month follow-up ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Peter Morris, MD
University of KentuckyLexingtonKentucky40536
Kirby Mayer, PT, DPT, PhD
Duke University Health SystemDurhamNorth Carolina27710
Amy Pastva, PT, PhD
The Ohio State University Wexner Medical CenterColumbusOhio43201
Nathan Brummel, MD
Vanderbilt University Medical CenterNashvilleTennessee37203
E Wesley Ely, MD

Find similar trials in Birmingham, AL

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of Kentucky· Lexington, KYDuke University Health System· Durham, NCThe Ohio State University Wexner Medical Center· Columbus, OHVanderbilt University Medical Center· Nashville, TN

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