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RecruitingNCT05962164COPDUpdated Apr 4, 2025

Passive Heat Therapy for People With COPD

An interventional study of Passive Heat Therapy and Sham Immersion in COPD and Cardiovascular Diseases, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COPD
  • Cardiovascular Diseases

Keywords

  • Passive Heat Therapy
  • Pulmonary Rehabilitation
  • Cardiovascular Health
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 32 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Passive Heat Therapy

  • Sham comparator
    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.

    Behavioral: Sham Immersion

Interventions

  • BehavioralPassive Heat Therapy

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

    Also known as: Lower-leg Hot Water Immersion, Footbath

  • BehavioralSham Immersion

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 6 weeks

Secondary outcomes

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

    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.

    Time frame: 6 weeks

  2. Arterial stiffness following chronic passive heat therapy

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

    Time frame: 6 weeks

  3. Exercise tolerance following chronic passive heat therapy

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

    Time frame: 6 weeks

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

    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.

    Time frame: During procedure: 60-minutes

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

    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.

    Time frame: During procedure: 60-minutes

Other outcomes

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

    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.

    Time frame: ~48 hours

07

Study locations

1 of 1 sites recruiting
  • University of British Columbia
    Kelowna, British Columbia V1V2L2, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05962164
Lead sponsor
University of British Columbia
Collaborators
Canadian Lung Association
Responsible party
Neil Eves (Professor, University of British Columbia) — Principal investigator
First posted
Jul 27, 2023
Start date
Aug 17, 2023
Primary completion
May 31, 2026 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Apr 4, 2025

Study contacts

Neil Eves, PhD
Contact
neil.eves@ubc.ca
(250) 807-9676
Kyla Coates, MSc
Contact
kyla.coates@ubc.ca
(250) 661-7207
Neil Eves, PhD
principal investigator · Associate Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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