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Covid19NCT04673318

Physical Rehabilitation of COVID-19 Survivors by Heat Therapy

A study testing heat therapy and exercise training in people with Covid19 and Physical Disability, run by University of Massachusetts, Amherst at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 55 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Covid19, Physical Disability
What is being tested?
heat therapy and exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteUnited States
Study dates
26 Feb 2021to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Institute of Applied Life Sciences

    Amherst, Massachusetts, 01003

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

    Mary Emma Searles, msearles@umass.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
heat therapy, exercise training
Keywords
physical rehabilitation, cardio-vascular function, metabolism, heat therapy
Medical subject headings
COVID-19, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • heat therapyBehavioural

    Also called exercise training

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

  • exercise trainingBehavioural

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

Study groups in NCT04673318
Study groupRoleWhat they receive
ControlNo interventionCourse of recovery with standard of care.
Exercise trainingActive comparatorlow resistance velocity based exercise training ~40 min, 3 times a week at home for 8 weeks
Receives: Behavioral: exercise training
heat therapyExperimentalheat therapy (~40C skin temperature) with a leg garment 5 times a week for 40-55 min for 8 weeks
Receives: Behavioral: heat therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait speed

    6-min walking distance

    Measured: 8 weeks

Secondary outcomes (4)
  1. Motor function

    Short Physical Performance Battery score

    Measured: 8 weeks

  2. Glucose control

    insulin and glucose levels during oral glucose tolerance test

    Measured: 8 weeks

  3. Skeletal muscle mitochondrial function

    Change in phosphocreatine recovery kinetics measured by 31-PMRS

    Measured: 8 weeks

  4. Vascular function

    Change in reactive hyperemia

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start26 Feb 2021
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673318
Sponsor's protocol ID
2151
Status last verified
Oct 2020
First submitted
23 Oct 2020
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing heat therapy and exercise training in people with Covid19 and Physical Disability, run by University of Massachusetts, Amherst at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait speed (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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