Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

NCT04673318 | Unknown

• 1 other identifier: 2151
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Older adults and people with underlying medical conditions are at higher risk for developing serious complications related to SARS-CoV-2 resulting in prolonged sequelae. The goal of this proposal is to compare the benefits of home-based lower limb heat therapy to exercise training on cardio-metabolic function and mobility in older adults during their convalescence from hospitalization due to SARS-CoV-2.

Conditions

Covid19; Physical Disability

Keywords

physical rehabilitation; cardio-vascular function; metabolism; heat therapy

Outcome Measures

Primary Outcomes (1)

• Gait speed

  6-min walking distance

  8 weeks

Secondary Outcomes (4)

• Motor function

  8 weeks

• Glucose control

  8 weeks

• Skeletal muscle mitochondrial function

  8 weeks

• Vascular function

  8 weeks

Study Arms (3)

Control

NO INTERVENTION

Course of recovery with standard of care.

Exercise training

ACTIVE COMPARATOR

low resistance velocity based exercise training \~40 min, 3 times a week at home for 8 weeks

Behavioral: exercise training

heat therapy

EXPERIMENTAL

heat therapy (\~40C skin temperature) with a leg garment 5 times a week for 40-55 min for 8 weeks

Behavioral: heat therapy

Interventions

heat therapy BEHAVIORAL

leg heated garments with circulating water to conduct heat therapy at home

Also known as: exercise training

heat therapy

exercise training BEHAVIORAL

A velocity based training program will be implemented at home using a mobile app allowing for the quantification the relative intensity.

Exercise training

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women must not be taking hormone therapy
• Must have been hospitalized for, at least, 5 days for a COVID-19 related infection
• Must have been discharged from the hospital for, at least, 14 days

You may not qualify if:

• Orthopedic limitations that would prohibit from performing plantar-flexion or knee-extension exercise
• Contraindication to MRI (pacemaker, metal implants, or certain types of heart valves), or be at medical risk from undergoing an MRI examination
• Enrolled in a rehabilitation program
• BMI \<40 kg/m2 and weigh \<400lbs
• prior history of pulmonary embolism or deep vein thrombosis

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead

Study Sites (1)

Institute of Applied Life Sciences

Amherst, Massachusetts, 01003, United States

RECRUITING

MeSH Terms

Conditions

COVID-19; Hyperthermia

Interventions

Diathermy; Exercise

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; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: December 17, 2020
• Study Start: February 26, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 28, 2021

Record last verified: 2020-10

Locations

US (1)