Clinical trial NCT05962164: Passive Heat Therapy for People With COPD
Official title: The Acute and Chronic Benefits of Passive Heat Therapy for People With COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Cardiovascular Diseases
Keywords: Passive Heat Therapy
Pulmonary Rehabilitation
Cardiovascular Health
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Lung Association
First posted: 2023-07-27
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel 2-Arm Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: People with COPD are at higher risk of developing cardiovascular disease (CVD). While exercise training is a potent therapy for CVD, people with COPD have a low tolerance for exercise due to dyspnea and premature muscle fatigue. Thus, there is a need to develop more effective strategies to improve CVD risk in people with COPD. A novel way to reduce blood pressure and enhance arterial health is with passive heat therapy (PHT). An acute 45-min bout of lower limb hot-water immersion has been shown to increase leg blood flow and reduce blood pressure in healthy older adults, suggesting that PHT could have similar hypotensive and anti-atherosclerotic effects as exercise. Augmenting leg blood flow with PHT may also have functional benefits by reducing peripheral muscle fatigue and improving exercise tolerance. No study to date has looked at the acute and chronic hemodynamic and vascular responses to PHT in people with COPD, nor whether it can acutely or chronically improve exercise tolerance.

Eligibility criteria: Inclusion Criteria:

* Non-smoking individuals
* \>40 years of age
* Stable (exacerbation free for \>6 weeks), moderate-to-severe COPD (post bronchodilator FEV1/FVC \<lower limit of normal and FEV1 z-score \<2.51)

Exclusion Criteria:

* Performing structured exercise training (i.e. pulmonary rehabilitation)
* Have advanced cardiac or cerebrovascular disease (i.e. a history of heart failure, previous stroke or myocardial infarction)
* Have uncontrolled hypertension (\>160/95 mmHg at rest)
* Have hypotension (\<110/60 mmHg)
* Are taking Beta Blockers
* Regularly (\>1/week) have hot baths (\>30 min) or use a hot tub or sauna.

Exclusion Criteria for exercise outcomes:

* Have resting blood pressure \> 150/95 mmHg
* On supplemental oxygen for hypoxemia.
* Musculoskeletal pain that limits their ability to perform stationary cycling.

Primary outcomes:
measure: Mean 24-hour ambulatory blood pressure following chronic passive heat therapy
timeFrame: 6 weeks
Secondary outcomes:
measure: Flow mediated dilation of the superficial femoral artery following chronic passive heat therapy.
timeFrame: 6 weeks
measure: Arterial stiffness following chronic passive heat therapy
timeFrame: 6 weeks
measure: Exercise tolerance following chronic passive heat therapy
timeFrame: 6 weeks
measure: The acute changes in leg blood flow from a single bout of passive heat therapy
timeFrame: During procedure: 60-minutes
measure: The acute changes in superficial femoral artery shear stress from a single bout of passive heat therapy
timeFrame: During procedure: 60-minutes
Other outcomes:
measure: The acute change in exercise tolerance following a single bout of PHT vs. the change with sham treatment
timeFrame: ~48 hours
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Associate Professor
name: Neil Eves, PhD
role: PRINCIPAL_INVESTIGATOR
References: