Heat thErapy And mobiLity in COVID-19 Survivors (HEAL)

October 21, 2025 updated by: University of Nebraska

Physical Rehabilitation of Long COVID by Heat Therapy

Post-acute sequelae of SARS-CoV-2 infection (PASC) is becoming a major risk factor for chronic diseases, with older adults and those with underlying health conditions at risk of developing persistent mobility limitations and disabilities. Although exercise intervention is a common strategy to restore functional capacity, it may not be feasible or enticing to many people with PASC. This clinical trial seeks to establish the tolerability and efficacy of at home lower-body heat therapy for improving functional capacity along with metabolic and vascular health in late-middle aged and older adults with PASC, also known as "long COVID".

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Post-acute sequelae of SARS-CoV-2 infection (PASC) affects 5 out of 10 patients hospitalized for the coronavirus disease 2019 (COVID-19) and ~11% of all adults infected by SARS-CoV-2, which makes this condition a growing public health concern. It is associated with important disabilities, cognitive dysfunction, and increased risks for cardiovascular and metabolic diseases. Although exercise-based intervention is a promising rehabilitation strategy, participation rates are commonly low in clinical population. In addition, post-exertional malaise, a common symptom with PASC, is a major safety concern in these patients, which may prevent a significant proportion of these individuals to receive adequate rehabilitation. In this context, there is a critical need to develop well-tolerated and effective strategies at home that ameliorates health and functional capacity in individuals with PASC. One promising approach that offers numerous health benefits is whole-body heat therapy. Whether this intervention is effective when confined to the lower body and well tolerated at home in people with PASC is, however, unknown.

The overall objective of this project is to determine the safety, tolerability, and efficacy of home-based lower body heat therapy in late middle-age and older adults with PASC. Investigators will test the central hypothesis that home-based lower body heat therapy is safe, well adhered, and can improve functional capacity and several surrogate markers for metabolic and vascular health in late-middle age and older adults with PASC. Specific Aim 1 will test the hypothesis that lower body heat therapy at home is safe, well adhered, and improve both cognitive and physical function in middle-age and older adults with PASC. Selected participants will be randomly allocated to perform 8 weeks of home-based lower body heat therapy (HT, skin temperature 38-40˚C, 40-55 min, 5 per week at home), a thermoneutral condition (CT, skin temperature 33˚C, same duration and frequency), or a walking intervention using wearable technology (WT, 1,500-3,000 additional steps from baseline, 3-5 days per week). We will compare the 6 min walking distance, the short physical performance battery test score, gait speed, cognitive function, incidence of adverse events, and participant's adherence to intervention between groups. Specific Aim 2 will test the hypothesis that heat therapy will attenuate inflammation, which will then decrease arterial stiffness, and improve both vascular endothelial function and muscle intracellular oxygen availability in participants with PASC. Investigators will use in vitro assays on blood samples and Doppler ultrasound techniques to assess changes in inflammation, redox status, pulse-wave velocity, and flow-mediated dilation. Muscle intracellular oxygen availability will be measured by magnetic resonance spectroscopy in vivo. Specific Aim 3 will test the hypothesis that lower body heat therapy will improve glucose control as a result of enhanced mitochondrial function. All these effects will not be statistically inferior to the WT group. The proposed research is highly significant as it is easily translatable and is expected to guide future rehabilitation strategies to mitigate long-term disabilities in patients with PASC.

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68182
        • Recruiting
        • University of Nebraska Omaha
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between the ages of 50 and 90 years
  • Free from orthopedic limitations that would prohibit performing leg exercise
  • BMI < 40 kg/m2 and weigh < 400lbs
  • Previously contracted Covid-19 and have persistent symptoms such as a fatigue or decline in physical function, for at least 2 months following SARS-CoV-2 infection

Exclusion Criteria:

  • Unable to give written informed consent
  • Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months
  • Women who are taking hormone therapy
  • Claustrophobia
  • Orthopedic limitations that would prohibit them from walking
  • Currently enrolled in an exercise-based or respiratory muscle rehabilitation program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heat Therapy
At home heat therapy 5 times (40-55 min) per week for 8 weeks.
Behavioral: Heat therapy
At home lower body heat therapy
Sham Comparator: Control Therapy
Sham at home thermoneutral therapy 5 times (40-55 min) per week for 8 weeks.
Behavioral: Sham Control
Sham Thermoneutral
Active Comparator: Walking Intervention Using Wearable Technology
+1,500-3000 steps per day 3-5 days a week for 8 weeks.
Behavioral: Walking
Walking intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 min walking distance
Time Frame: 8 weeks
Distance covered during 6 min of walking
8 weeks
Short Physical Performance Battery Test
Time Frame: 8 weeks
Test of physical functional capacity
8 weeks
Arterial stiffness
Time Frame: 8 weeks
Pulse Wave velocity
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Gwenael Layec, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0550-24-FB
  • R01AG089307 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified data will be deposited into a Data Repository specific to biomedical sciences using standard rights waivers as those established by Open Data Commons (ODC)

IPD Sharing Time Frame

The research community will have access to data at the end of the grant award or when a publication has been submitted, whichever comes first.

IPD Sharing Access Criteria

Data will be deposited on open access platform and we will use standard rights waivers established by Open Data Commons (ODC).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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