Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

Conditions
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Covid19, Physical Disability

Intervention / Treatment
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* Behavioral: heat therapy
* Behavioral: exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical rehabilitation, cardio-vascular function, metabolism, heat therapy