An interventional study of Heat therapy and Sham Control in Long COVID, sponsored by University of Nebraska. Recruiting at 1 site in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
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".
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.
604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.
This study's planned enrollment of 99 is above the median of 60 across 416 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 28, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At home heat therapy 5 times (40-55 min) per week for 8 weeks.
Behavioral: Heat therapy
Sham at home thermoneutral therapy 5 times (40-55 min) per week for 8 weeks.
Behavioral: Sham Control
+1,500-3000 steps per day 3-5 days a week for 8 weeks.
Behavioral: Walking
At home lower body heat therapy
Sham Thermoneutral
Walking intervention
6 min walking distance
Distance covered during 6 min of walking
Time frame: 8 weeks
Short Physical Performance Battery Test
Test of physical functional capacity
Time frame: 8 weeks
Arterial stiffness
Pulse Wave velocity
Time frame: 8 weeks
Plan to share: Yes — 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)
Supporting information: Study protocol
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.
Access criteria: Data will be deposited on open access platform and we will use standard rights waivers established by Open Data Commons (ODC).
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Post-Acute COVID-19 Syndrome →