REmotely monitored, Mobile health-supported Multidomain Rehabilitation Program incorporating High-intensity Interval Training for COVID-19 (REMM-HIIT-CoV): trial design and rationale.
Ashley L Artese, Kirby P Mayer, Megan Beyer, Marjan Cobbaert, E Wesley Ely, Heath Gasier, Matthew F Mart, Jeroen Molinger, Brenda T Pun, Onur M Orun, Rameela Raman, Anthony D Sung, Paul E Wischmeyer, Amy M Pastva
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引用次数: 0
Abstract
Importance: Individuals hospitalized with COVID-19 are at increased risk for prolonged physical, cognitive, and psychosocial impairments. Timely post-acute rehabilitation may reduce these sequelae and accelerate recovery.
Objective: The objective is to determine whether a REmotely monitored, Mobile health-supported Multidomain Rehabilitation Program incorporating High-intensity Interval Training (REMM-HIIT-CoV) after COVID-19 hospitalization improves functional exercise capacity.
Design: This study is a multicenter, single-blinded, attention controlled, prospective randomized controlled trial.
Setting: Five academic medical centers will enroll participants for remotely delivered and monitored rehabilitation.
Participants: The study will enroll 140 community-dwelling adults discharged within 60 days of COVID-19 hospitalization.
Intervention: Participants are randomized to either (1) a 12-week, individually tailored, structured and progressive multidomain physical rehabilitation intervention-targeting deficits in balance, mobility, strength, and endurance-delivered via videoconference and remotely monitored using activity trackers and a mobile health application; or (2) an exercise education control group without individualized exercise prescription.
Main outcomes and measures: The primary outcome is functional exercise capacity, measured by 6-min walk distance at 3 months post-randomization. Secondary outcomes include cardiorespiratory fitness (VO2peak), physical function (Short Physical Performance Battery, 30 Second Sit-to-Stand, Grip Strength), frailty (Fried Frailty Index), and cognitive function (Montreal Cognitive Assessment), self-reported quality of life (EQ-5D-5L), functional status (Duke Activity Status Index, Lawton Instrumental Activities of Daily Living), mental health (Hospital Anxiety and Depression Scale), and health-related social needs (Accountable Health Communities Health-related Social Needs Screening Tool). Exploratory outcomes include blood-derived biomarkers of inflammation and mitochondrial function, and ultrasound measures of lower extremity skeletal muscle structure.
Conclusions: REMM-HIIT-CoV is the first randomized trial to evaluate a remotely delivered, structured, and tailored multidomain rehabilitation program incorporating HIIT in post-hospitalized COVID-19 survivors.
Relevance: Findings may inform evidence-based guidelines and policy-relevant models for home-based remote rehabilitation after severe respiratory infections.
期刊介绍：
Physical Therapy (PTJ) engages and inspires an international readership on topics related to physical therapy. As the leading international journal for research in physical therapy and related fields, PTJ publishes innovative and highly relevant content for both clinicians and scientists and uses a variety of interactive approaches to communicate that content, with the expressed purpose of improving patient care. PTJ"s circulation in 2008 is more than 72,000. Its 2007 impact factor was 2.152. The mean time from submission to first decision is 58 days. Time from acceptance to publication online is less than or equal to 3 months and from acceptance to publication in print is less than or equal to 5 months.
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