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

Trial Summary

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.

How is passive heat therapy different from other treatments for COPD?

Passive heat therapy is unique because it involves using heat to improve circulation and relax muscles, which may help with breathing in COPD patients. Unlike traditional treatments like home oxygen therapy or exercise programs, passive heat therapy does not require active participation or physical exertion, making it potentially beneficial for those unable to engage in regular exercise. ^{1 2 3 4 5}

What is the purpose of this trial?

People with Chronic Obstructive Pulmonary Disease (COPD) often develop high blood pressure and heart disease due to their sedentary lifestyle and difficulty exercising. The investigators will test if heating can mimic the health benefits of exercise by monitoring the increase in leg blood-flow using ultrasound during a 45-minute hot-water footbath. The patients will then undergo 6-weeks of hot-water footbaths to examine whether the changes to blood-flow lead to improvements in blood pressure and other indicators of heart disease risk.

Research Team

Neil Eves, PhD

Principal Investigator

Associate Professor

Eligibility Criteria

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 have a history of serious heart or stroke issues.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. Japan pubmed.ncbi.nlm.nih.gov

[The indication and practice of home oxygen therapy]. [2016]

2. England pubmed.ncbi.nlm.nih.gov

The effect of home oxygen therapy on hospitalization in moderate hypoxaemic COPD. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation of the patient with COPD. [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

[Home oxygen therapy and noninvasive ventilation for stable COPD]. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

[Spiroergometry in patients with severe chronic obstructive pulmonary disease confined to bed]. [2013]