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Status unknownNCT04673318Updated Apr 28, 2021

Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

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

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19
  • Physical Disability

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Keywords

  • physical rehabilitation
  • cardio-vascular function
  • metabolism
  • heat therapy
03

In context

COVID-19

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.

Browse COVID-19 studies →

Lead sponsor

University of Massachusetts, Amherst is the lead sponsor of 45 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
87 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Behavioralheat therapy

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

    Also known as: exercise training

  • Behavioralexercise training

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

06

What researchers measure

Primary outcomes

  1. Gait speed

    6-min walking distance

    Time frame: 8 weeks

Secondary outcomes

  1. Motor function

    Short Physical Performance Battery score

    Time frame: 8 weeks

  2. Glucose control

    insulin and glucose levels during oral glucose tolerance test

    Time frame: 8 weeks

  3. Skeletal muscle mitochondrial function

    Change in phosphocreatine recovery kinetics measured by 31-PMRS

    Time frame: 8 weeks

  4. Vascular function

    Change in reactive hyperemia

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Institute of Applied Life Sciences
    Amherst, Massachusetts 01003, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04673318
Lead sponsor
University of Massachusetts, Amherst
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Feb 26, 2021
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Apr 28, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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