Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

Covid19 Clinical Trial

Official title:

Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04673318
• Other study ID #: 2151
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: December 2024

Study information

• Verified date: October 2020
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Physical Disability

Intervention

Behavioral:
• heat therapy
leg heated garments with circulating water to conduct heat therapy at home
• exercise training
A velocity based training program will be implemented at home using a mobile app allowing for the quantification the relative intensity.

Locations

Country	Name	City	State
United States	Institute of Applied Life Sciences	Amherst	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed	6-min walking distance	8 weeks
Secondary	Motor function	Short Physical Performance Battery score	8 weeks
Secondary	Glucose control	insulin and glucose levels during oral glucose tolerance test	8 weeks
Secondary	Skeletal muscle mitochondrial function	Change in phosphocreatine recovery kinetics measured by 31-PMRS	8 weeks
Secondary	Vascular function	Change in reactive hyperemia	8 weeks