Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

NCT ID: NCT04673318

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Covid19; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

Course of recovery with standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise training

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

Group Type: ACTIVE_COMPARATOR

exercise training

Intervention Type: BEHAVIORAL

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

heat therapy

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

Group Type: EXPERIMENTAL

heat therapy

Intervention Type: BEHAVIORAL

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

Interventions

heat therapy

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

Intervention Type: BEHAVIORAL

exercise training

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

Intervention Type: BEHAVIORAL

Other Intervention Names

exercise training

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Massachusetts, Amherst

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Applied Life Sciences

Amherst, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Gwenael Layec, PhD

Role: primary

glayec@umass.edu

413-545-1451

Mary Emma Searles

Role: backup

msearles@umass.edu

Other Identifiers

2151

Identifier Type: -

Identifier Source: org_study_id