An interventional study of heat therapy and exercise training in Covid19 and Physical Disability, sponsored by University of Massachusetts, Amherst. Status unknown at 1 site in United States. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University of Massachusetts, Amherst · Not applicable, Interventional, and Basic science
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 87 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
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Exclusion Criteria:
Course of recovery with standard of care.
low resistance velocity based exercise training \~40 min, 3 times a week at home for 8 weeks
Behavioral: exercise training
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
Also known as: exercise training
A velocity based training program will be implemented at home using a mobile app allowing for the quantification the relative intensity.
Gait speed
6-min walking distance
Time frame: 8 weeks
Motor function
Short Physical Performance Battery score
Time frame: 8 weeks
Glucose control
insulin and glucose levels during oral glucose tolerance test
Time frame: 8 weeks
Skeletal muscle mitochondrial function
Change in phosphocreatine recovery kinetics measured by 31-PMRS
Time frame: 8 weeks
Vascular function
Change in reactive hyperemia
Time frame: 8 weeks
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Amherst