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NCT Number: NCT05962164

Passive Heat Therapy for People With COPD

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Kelowna, British Columbia, V1V2L2, Canada

Location status: Recruiting

Location contact

Neil Eves, PhD

CONTACT

[email protected]

250-807-9676

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Passive Heat Therapy

Behavioral

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

Other names: Lower-leg Hot Water Immersion, Footbath

Sham Immersion

Behavioral

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

Primary outcomes

  1. Mean 24-hour ambulatory blood pressure following chronic passive heat therapy

    Time frame: 6 weeks

    The change in 24-hour ambulatory systolic, diastolic and mean arterial blood pressure from baseline to post intervention.

Secondary outcomes

  1. Flow mediated dilation of the superficial femoral artery following chronic passive heat therapy.

    Time frame: 6 weeks

    The change in the percent dilation of the superficial femoral artery (measured using ultrasound) in response to reactive hyperemia (from a 5-min supra-systolic occlusion) from baseline to post intervention.

  2. Arterial stiffness following chronic passive heat therapy

    Time frame: 6 weeks

    The change in pulse wave velocity (m/s) measured by applanation tonometry from baseline to post intervention.

  3. Exercise tolerance following chronic passive heat therapy

    Time frame: 6 weeks

    The change in constant load exercise time (seconds) at 75% of peak power from baseline to post intervention.

  4. The acute changes in leg blood flow from a single bout of passive heat therapy

    Time frame: During procedure: 60-minutes

    Superficial femoral artery blood flow (mL/min) will be measured by duplex ultrasound. Measurements will be taken every 15-min throughout immersion until 15-min following the first session of passive heat therapy or Sham treatment.

  5. The acute changes in superficial femoral artery shear stress from a single bout of passive heat therapy

    Time frame: During procedure: 60-minutes

    Superficial femoral artery shear stress (1/s) patterns will be measured by duplex ultrasound. Measurements will be taken every 15-min throughout immersion until 15-min following the first session of passive heat therapy or Sham treatment.

Other outcomes

  1. The acute change in exercise tolerance following a single bout of PHT vs. the change with sham treatment

    Time frame: ~48 hours

    Constant load exercise time to exhaustion (seconds) at 75% of Peak Power will be completed at baseline and 15-min after PHT or Sham Immersion. The change in post-PHT time to exhaustion from the baseline exercise trial will be compared with the change in post-sham time to exhaustion from the baseline exercise trial.

Study contacts

Contact information is provided by the study sponsor or research team.

Kyla Coates, MSc

CONTACT

[email protected]

(250) 661-7207

Neil Eves, PhD

CONTACT

[email protected]

(250) 807-9676

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Lung Association

Registry information

Official study title

The Acute and Chronic Benefits of Passive Heat Therapy for People With COPD

Acronym: COPD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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