Passive Heat Therapy for People With COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COPD Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel 2-Arm Randomized Control Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinding of the participant to the condition (heat therapy or sham) is not possible. Data that needs to be analyzed (i.e. ultrasound videos for blood flow and FMD) will be coded by a team member that is not involved in data collection or analysis. The outcomes assessor will be blind to the participant, condition and time point of the file. Breaking of the code will only occur when all data analysis is complete.

Study Groups

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Passive Heat Therapy

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 Type EXPERIMENTAL

Passive Heat Therapy

Intervention Type BEHAVIORAL

The intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.

Sham Immersion

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.

Group Type SHAM_COMPARATOR

Sham Immersion

Intervention Type BEHAVIORAL

The sham intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.

Interventions

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Passive Heat Therapy

The intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.

Intervention Type BEHAVIORAL

Sham Immersion

The sham intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.

Intervention Type BEHAVIORAL

Other Intervention Names

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Lower-leg Hot Water Immersion Footbath

Eligibility Criteria

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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.

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No