Heat Therapy for Post-COVID Syndrome

(HEAL Trial)

Overseen By Gwenael Layec, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Pregnancy, Hormone therapy, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

99 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is heat therapy safe for humans?

While there is no specific safety data on heat therapy for post-COVID syndrome, exercise programs for post-COVID patients have been well tolerated with no adverse events reported. It's important to have medical examinations beforehand and regularly evaluate individual responses to ensure safety. ^{1 2 3 4 5}

How does heat therapy differ from other treatments for post-COVID syndrome?

Heat therapy is unique because it uses warmth to potentially alleviate symptoms, which is different from other treatments like acupuncture or eHealth interventions that focus on physical activity or digital management. This approach may offer a novel way to address the multisystem nature of post-COVID syndrome by promoting relaxation and improving circulation. ^{3 6 7 8 9}

What is the purpose of this trial?

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".

Research Team

Gwenael Layec, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for late-middle aged and older adults who have had COVID-19 and are now experiencing long-term effects, known as 'long COVID'. Participants should be interested in trying heat therapy at home to improve their mobility and overall health. Specific eligibility details are not provided.

Inclusion Criteria

I have had Covid-19 and still feel tired or weaker than usual for 2 months or more.

I am between 50 and 90 years old.

I can perform leg exercises without any orthopedic issues.

Exclusion Criteria

I am unable to sign a consent form.

Claustrophobia

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo home-based lower body heat therapy, thermoneutral therapy, or a walking intervention for 8 weeks

8 weeks

5 sessions per week (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Heat therapy

Trial Overview The study is testing if lower-body heat therapy can help people with long COVID get better at moving around and feeling healthier. It also looks at how this might affect their metabolism and blood vessels compared to a sham control group.

Participant Groups

Group I: Heat Therapy Experimental Treatment 1 Intervention

At home heat therapy 5 times (40-55 min) per week for 8 weeks.

Group II: Walking Intervention Using Wearable Technology Active Control 1 Intervention

+1,500-3000 steps per day 3-5 days a week for 8 weeks.

Group III: Control Therapy Placebo Group 1 Intervention

Sham at home thermoneutral therapy 5 times (40-55 min) per week for 8 weeks.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

A study involving 57 patients with persistent fatigue post-COVID showed that a 4-week supervised exercise program significantly improved their maximal exercise capacity (VO2peak) compared to usual care, with no adverse events reported.

While both exercise and usual care groups experienced improvements in fatigue and quality of life over time, the exercise group engaged in significantly more physical activity during the follow-up period, suggesting that exercise is a safe option for enhancing recovery in post-COVID patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise as a treatment for persisting symptoms post-COVID infection: review of ongoing studies and prospective randomized controlled training study. Kogel, A., Machatschek, M., Scharschmidt, R., et al.[2023]

A 50-year-old woman with post-COVID syndrome experienced significant symptom relief, including resolution of chest pressure and palpitations, after just one acupuncture treatment, followed by complete recovery after a total of seven sessions combined with symptom-titrated physical activity.

The case suggests that acupuncture may be a beneficial component of a multidisciplinary approach to treating post-COVID syndrome, although further research is needed to isolate its effects from concurrent therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture in Multidisciplinary Treatment for Post-COVID-19 Syndrome. Trager, RJ., Brewka, EC., Kaiser, CM., et al.[2022]

In a study involving 10 individuals recently discharged after severe COVID-19, all participants safely completed three different high-intensity interval training (HIIT) protocols without any adverse events, indicating that HIIT can be tolerated post-hospitalization.

The study found that while all HIIT protocols achieved high exercise intensities, they differed in the duration spent at maximum heart rate, suggesting that different HIIT formats can be effectively utilized for rehabilitation in COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fidelity, tolerability and safety of acute high-intensity interval training after hospitalisation for COVID-19: a randomised cross-over trial. Foged, F., Rasmussen, IE., Bjørn Budde, J., et al.[2023]

Exercise interventions for non-hospitalized individuals with Post COVID-19 Syndrome (PCS) have been shown to improve aerobic fitness, physical function, and reduce symptoms like dyspnea, fatigue, and depression, based on a review of seven studies involving 935 participants.

The exercise programs were well tolerated with no reported adverse events, but safety measures such as medical evaluations and monitoring individual responses are crucial, especially for patients with post-exertional malaise or chronic fatigue syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training in Non-Hospitalized Patients with Post-COVID-19 Syndrome-A Narrative Review. Sick, J., König, D.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Post-COVID Conditions. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Physical exercise as a treatment for persisting symptoms post-COVID infection: review of ongoing studies and prospective randomized controlled training study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Acupuncture in Multidisciplinary Treatment for Post-COVID-19 Syndrome. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Fidelity, tolerability and safety of acute high-intensity interval training after hospitalisation for COVID-19: a randomised cross-over trial. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise Training in Non-Hospitalized Patients with Post-COVID-19 Syndrome-A Narrative Review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Acceptance, drivers, and barriers to use eHealth interventions in patients with post-COVID-19 syndrome for management of post-COVID-19 symptoms: a cross-sectional study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Systematic review of post-COVID-19 syndrome rehabilitation guidelines. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Post COVID-19 neuropsychiatric complications and therapeutic role for TNF-α inhibitors: a case series study. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Mobile primary healthcare for post-COVID patients in rural areas: a proof-of-concept study. [2023]