Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

• ClinicalTrials.gov Identifier: NCT04673318
• Recruitment Status: Recruiting
• First Posted: December 17, 2020
• Last Update Posted: April 28, 2021
• Sponsor: University of Massachusetts, Amherst
• Information provided by (Responsible Party): University of Massachusetts, Amherst

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Covid19; Physical Disability	Behavioral: heat therapy; Behavioral: exercise training	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Physical Rehabilitation of COVID-19 Survivors by Heat Therapy
• Actual Study Start Date: February 26, 2021
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: December 2024

Arms and Interventions

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 Name: exercise training

Outcome Measures

Primary Outcome Measures :

1. Gait speed [ Time Frame: 8 weeks ]
   6-min walking distance

Secondary Outcome Measures :

1. Motor function [ Time Frame: 8 weeks ]
   Short Physical Performance Battery score
2. Glucose control [ Time Frame: 8 weeks ]
   insulin and glucose levels during oral glucose tolerance test
3. Skeletal muscle mitochondrial function [ Time Frame: 8 weeks ]
   Change in phosphocreatine recovery kinetics measured by 31-PMRS
4. Vascular function [ Time Frame: 8 weeks ]
   Change in reactive hyperemia

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Massachusetts

Institute of Applied Life Sciences; Recruiting

Amherst, Massachusetts, United States, 01003

Contact: Gwenael Layec, PhD 413-545-1451 glayec@umass.edu

Contact: Mary Emma Searles msearles@umass.edu

Sponsors and Collaborators

University of Massachusetts, Amherst

More Information

• Responsible Party: University of Massachusetts, Amherst
• ClinicalTrials.gov Identifier: NCT04673318
• Other Study ID Numbers: 2151
• First Posted: December 17, 2020
• Last Update Posted: April 28, 2021
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Massachusetts, Amherst:

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

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases