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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Institute of Applied Life Sciences
Amherst, Massachusetts, 01003
Gwenael Layec, PhD, 413-545-1451, glayec@umass.edu
Mary Emma Searles, msearles@umass.edu
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.
- Conditions
- Covid19, Physical Disability
- 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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Course of recovery with standard of care. |
| Exercise training | Active comparator | low resistance velocity based exercise training ~40 min, 3 times a week at home for 8 weeks Receives: Behavioral: exercise training |
| heat therapy | Experimental | heat 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.
Gait speed
6-min walking distance
Measured: 8 weeks
Secondary outcomes (4)
Motor function
Short Physical Performance Battery score
Measured: 8 weeks
Glucose control
insulin and glucose levels during oral glucose tolerance test
Measured: 8 weeks
Skeletal muscle mitochondrial function
Change in phosphocreatine recovery kinetics measured by 31-PMRS
Measured: 8 weeks
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.
- First posted17 Dec 2020
- Study start26 Feb 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Rehabilitation of COVID-19 Survivors by Heat Therapy
- ClinicalTrials.gov ID
- NCT04673318
- Acronym / sponsor ID
- 2151
- Conditions
- Covid19, Physical Disability
- Keywords
- physical rehabilitation, cardio-vascular function, metabolism, heat therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Course of recovery with standard of care. |
| Exercise training | Active comparator | Behavioral: exercise traininglow resistance velocity based exercise training ~40 min, 3 times a week at home for 8 weeks |
| heat therapy | Experimental | Behavioral: heat therapyheat therapy (~40C skin temperature) with a leg garment 5 times a week for 40-55 min for 8 weeks |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heat therapyAlso: exercise trainingleg heated garments with circulating water to conduct heat therapy at home | Behavioural | heat therapy |
| exercise trainingA velocity based training program will be implemented at home using a mobile app allowing for the quantification the relative intensity. | Behavioural | Exercise training |
Primary outcome
Gait speed
Time frame: 8 weeks
6-min walking distance
4 secondary outcomes
Motor function
Time frame: 8 weeks
Glucose control
Time frame: 8 weeks
Skeletal muscle mitochondrial function
Time frame: 8 weeks
Vascular function
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.