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Heat Therapy vs Exercise Training for COVID-19 Recovery

N/A
Recruiting
Research Sponsored by University of Massachusetts, Amherst
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women must not be taking hormone therapy
Be older than 18 years old
Must not have
Contraindication to MRI (pacemaker, metal implants, or certain types of heart valves), or be at medical risk from undergoing an MRI examination
Orthopedic limitations that would prohibit from performing plantar-flexion or knee-extension exercise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will 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.

Who is the study for?
This trial is for adults who were hospitalized with COVID-19 and have been out of the hospital for at least two weeks. They shouldn't be on hormone therapy or involved in another rehab program, and must be able to do certain leg exercises. People with metal implants, pacemakers, or a history of blood clots, as well as those extremely overweight cannot join.
What is being tested?
The study is testing if heat therapy applied to the lower limbs at home can improve heart health and walking ability after COVID-19 better than exercise training alone. Participants will either receive heat treatment or perform specific exercises.
What are the potential side effects?
Heat therapy may cause skin irritation or burns if not properly administered. Exercise might lead to muscle soreness or strain. Both interventions could potentially exacerbate underlying conditions but are generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently on hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have an MRI due to a pacemaker, metal implants, or specific heart valves.
Select...
I cannot do certain leg exercises due to orthopedic issues.
Select...
I have had a blood clot in my lung or deep veins before.
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My BMI is under 40 and I weigh less than 400lbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gait speed
Secondary study objectives
Glucose control
Motor function
Skeletal muscle mitochondrial function
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: heat therapyExperimental Treatment1 Intervention
heat therapy (\~40C skin temperature) with a leg garment 5 times a week for 40-55 min for 8 weeks
Group II: ControlActive Control1 Intervention
Course of recovery with standard of care.
Group III: Exercise trainingActive Control1 Intervention
low resistance velocity based exercise training \~40 min, 3 times a week at home for 8 weeks

Find a Location

Who is running the clinical trial?

University of Massachusetts, AmherstLead Sponsor
81 Previous Clinical Trials
468,063 Total Patients Enrolled

Media Library

Exercise Training Clinical Trial Eligibility Overview. Trial Name: NCT04673318 — N/A
Coronavirus Research Study Groups: Control, Exercise training, heat therapy
Coronavirus Clinical Trial 2023: Exercise Training Highlights & Side Effects. Trial Name: NCT04673318 — N/A
Exercise Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04673318 — N/A
~0 spots leftby Dec 2024
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