Passive Heat Therapy for COPD

(COPD Trial)

Overseen By Kyla Coates, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Beta blockers

Disqualifiers: Advanced cardiac, Cerebrovascular, Hypertension, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether sitting with legs in hot water can improve blood flow in individuals with Chronic Obstructive Pulmonary Disease (COPD), potentially lowering blood pressure and reducing heart disease risk. Participants will either sit in hot water or a regular warm water footbath to determine if the heat provides benefits similar to exercise. This trial may suit non-smoking individuals over 40 with stable, moderate-to-severe COPD who do not regularly exercise or have certain heart conditions. As an unphased trial, it offers a unique opportunity to explore innovative, non-drug interventions for COPD management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking beta blockers.

What prior data suggests that passive heat therapy is safe for people with COPD?

Past studies have shown that passive heat therapy improves heart health and blood flow in older adults, even those with chronic illnesses. Research indicates that this therapy, such as using a hot-water footbath, is generally well-tolerated. No major reports of serious side effects have been linked to this therapy. Evidence from studies on Finnish saunas, another form of passive heat therapy, also suggests they can reduce the risk of certain health issues, supporting the idea that passive heat is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for COPD involve medications like bronchodilators or corticosteroids that help open airways and reduce inflammation. However, passive heat therapy stands out by immersing patients' lower legs in a hot water bath, which is thought to improve circulation and reduce symptoms through heat exposure. This non-invasive approach offers a unique delivery method that might enhance blood flow and oxygenation without the need for pharmaceuticals. Researchers are excited about its potential to offer relief without medication-related side effects, making it a promising alternative or complementary option for managing COPD.

What evidence suggests that passive heat therapy might be an effective treatment for COPD?

Research shows that passive heat therapy, which participants in this trial may receive, can enhance heart and blood vessel health. Studies have found it lowers blood pressure and improves artery health, particularly in older adults, by increasing blood flow. For individuals with chronic health conditions, passive heat therapy has been linked to improved exercise capacity and quality of life. Some research also suggests it can help reduce high blood pressure in the lungs during exercise. These findings indicate that passive heat therapy might offer similar benefits to people with COPD (a lung disease that makes breathing difficult) by improving heart health and blood flow. ^{1 2 3 4 5}

Who Is on the Research Team?

Neil Eves, PhD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

This trial is for people over 40 with moderate-to-severe COPD who haven't smoked recently and have been stable for at least 6 weeks. It's not for those on Beta Blockers, in exercise programs, with advanced heart or brain vessel disease, uncontrolled high blood pressure, very low blood pressure, or those frequently using hot baths or saunas.

Inclusion Criteria

I am over 40, don't smoke, and have severe COPD.

Exclusion Criteria

Having hypotension (<110/60 mmHg)

I am currently taking beta blockers.

I use extra oxygen because I have low blood oxygen levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Phase

Participants undergo a single 45-minute session of hot-water footbath to measure acute changes in leg blood flow and exercise tolerance

1 week

1 visit (in-person)

Treatment

Participants undergo 6 weeks of hot-water footbaths to examine chronic changes in blood flow, blood pressure, and exercise tolerance

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Passive Heat Therapy

Trial Overview The study tests if Passive Heat Therapy (45-minute hot-water footbaths) can improve leg blood-flow and reduce heart disease risk in COPD patients. Over six weeks, the effects of regular footbaths are compared to Sham Immersion (a fake treatment) to see if there are benefits similar to exercising.

How Is the Trial Designed?

Group I: Passive Heat Therapy Experimental Treatment 1 Intervention

Patients with COPD assigned to passive heat therapy will have their lower legs immersed in a circulating hot water (\~42°C) footbath for 45 min per session.

Group II: Sham Immersion Placebo Group 1 Intervention

Patients with COPD assigned to the sham condition will have their lower legs immersed in a circulating thermoneutral (\~36°C) footbath for 45 min per session.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Lung Association

Industry Sponsor

Trials

10

Recruited

65,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05962164

NCT05962164 | Passive Heat Therapy for People With COPD The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. ctv.veeva.com ctv.veeva.com/study/passive-heat-therapy-for-people-with-copd

Passive Heat Therapy for People With COPD A novel way to reduce blood pressure and enhance arterial health is with passive heat therapy (PHT).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10989710/

The multifaceted benefits of passive heat therapies for ... Four weeks of Waon therapy has been shown to improve pulmonary hypertension during exercise, exercise tolerance, and the quality of life in patients with severe ...

4. journals.physiology.org journals.physiology.org/doi/full/10.1152/japplphysiol.00701.2023

Passive heat therapy: a promising preventive measure for ... Passive heat therapy improves cardiovascular function and health in middle-aged and older adults living with or without chronic diseases.

5. withpower.com withpower.com/trial/phase-cardiovascular-diseases-7-2023-ecc8e

Passive Heat Therapy for COPD (COPD Trial) Trial Overview The study tests if Passive Heat Therapy (45-minute hot-water footbaths) can improve leg blood-flow and reduce heart disease risk in COPD patients ...