Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Physical Disability
• Intervention / Treatment: Behavioral: exercise training; Behavioral: heat therapy

Detailed Description

The novel coronavirus (severe acute respiratory syndrome [SARS]-CoV-2), first identified in December 2019 in Wuhan, China, has since spread worldwide. Older adults and people with underlying medical conditions are at higher risk for developing serious complications and death related to SARS-CoV-2. However, another challenge is arising in regards to the long-term prognosis of COVID-19 survivors. Although limited, the available data on the medium-term outcomes of patients who survived COVID-19 all indicate prolonged symptom duration and disability in a large proportion of adults hospitalized with severe symptoms. In addition, these patients, a majority of whom were older adults or patients with pre-existing health conditions, spent ~10-15 days bedridden and under intensive treatment, which can have lasting consequences on metabolism and cardiovascular functions, mobility, and eventually lead to long-term disabilities. Upon discharge from the hospital, the main option for physical rehabilitation involves exercise training. Although, exercise training can be effective to restore physical function, it is oftentimes associated with low adherence. Considering the severe deconditioning accompanying hospitalization related to COVID-19, there is a critical need for the development of a rehabilitation strategy that is home-based and practical to individuals with diminished physical function. Accordingly, the goal of this project is to compare the benefits of home-based lower limb chronic heat therapy to exercise training on skeletal muscle metabolism, vascular function and functional capacity in older adults during their convalescence from hospitalization due to SARS-CoV-2. Late middle-age and older adults that have been discharged from a COVID-19 hospitalization will be randomly allocated to an exercise intervention group (EX, low resistance ~40 min, 3 times a week at home), a heat-treated group (HT, leg heated garments with skin temperature reaching ~40˚C, 40-55 min, 5 times a week at home), or a control group (CT) for 8 weeks. Specific Aim 1 will test the hypothesis that local heat therapy in previously hospitalized COVID-19 patients can (i) enhance functional capacity, resulting in improvements in mobility and quality of life compared to a non-treated control group, and (ii) that these changes will be similar in magnitude to an exercise intervention. Specific Aim 2 will test the hypothesis that local heat therapy in the same patients can (i) enhance insulin sensitivity as a consequence of improvements in mitochondrial and vascular function compared to a non-treated control group, and (ii) that these changes will be similar in magnitude to an exercise intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • Recruiting
      • Institute of Applied Life Sciences
      • Contact: Mary Emma Searles; Email: msearles@umass.edu
      • Contact: Gwenael Layec, PhD; Phone Number: 413-545-1451; Email: glayec@umass.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Course of recovery with standard of care.
Active Comparator: Exercise training; low resistance velocity based exercise training ~40 min, 3 times a week at home for 8 weeks	Behavioral: exercise training; A velocity based training program will be implemented at home using a mobile app allowing for the quantification the relative intensity.
Experimental: heat therapy; heat therapy (~40C skin temperature) with a leg garment 5 times a week for 40-55 min for 8 weeks	Behavioral: heat therapy; leg heated garments with circulating water to conduct heat therapy at home; Other Names: exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	6-min walking distance	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor function	Short Physical Performance Battery score	8 weeks
Glucose control	insulin and glucose levels during oral glucose tolerance test	8 weeks
Skeletal muscle mitochondrial function	Change in phosphocreatine recovery kinetics measured by 31-PMRS	8 weeks
Vascular function	Change in reactive hyperemia	8 weeks

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: metabolism; heat therapy; physical rehabilitation; cardio-vascular function
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No