COPDCOPDNCT05962164
Passive Heat Therapy for People With COPD
A study testing Passive Heat Therapy in people with COPD and Cardiovascular Diseases, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Cardiovascular Diseases
- What is being tested?
- Passive Heat Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 17 Aug 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- Have resting blood pressure > 150/95 mmHg
- On supplemental oxygen for hypoxemia.
- Musculoskeletal pain that limits their ability to perform stationary cycling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Kelowna, British Columbia, V1V2L2
Neil Eves, PhD, 250-807-9676, neil.eves@ubc.ca
About this study
Official title: The Acute and Chronic Benefits of 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.
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.
- Conditions
- COPD, Cardiovascular Diseases
- Being tested
- Passive Heat Therapy, Sham Immersion
- Keywords
- Passive Heat Therapy, Pulmonary Rehabilitation, Cardiovascular Health
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Heat TherapyBehavioural
Also called Lower-leg Hot Water Immersion, Footbath
The intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.
Sham ImmersionBehavioural
The sham intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.
| Study group | Role | What they receive |
|---|---|---|
| Passive Heat Therapy | Experimental | 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. Receives: Behavioral: Passive Heat Therapy |
| Sham Immersion | Sham comparator | 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. Receives: Behavioral: Sham Immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (5)
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.
Measured: 6 weeks
Arterial stiffness following chronic passive heat therapy
The change in pulse wave velocity (m/s) measured by applanation tonometry from baseline to post intervention.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: During procedure: 60-minutes
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.
Measured: During procedure: 60-minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start17 Aug 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel 2-Arm Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Lung Association
- Responsible party
- Principal investigator, Neil Eves, University of British Columbia
- Investigators
- Neil Eves, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962164
- Sponsor's protocol ID
- H21-01868
- Acronym
- COPD
- Status last verified
- Apr 2025
- First submitted
- 30 Jun 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute and Chronic Benefits of Passive Heat Therapy for People With COPD
- ClinicalTrials.gov ID
- NCT05962164
- Acronym / sponsor ID
- COPD / H21-01868
- Conditions
- COPD, Cardiovascular Diseases
- Keywords
- Passive Heat Therapy, Pulmonary Rehabilitation, Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Lung Association
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel 2-Arm Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Passive Heat Therapy | Experimental | Behavioral: Passive Heat TherapyPatients 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. |
| Sham Immersion | Sham comparator | Behavioral: Sham ImmersionPatients 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 may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Heat TherapyAlso: Lower-leg Hot Water Immersion, FootbathThe intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions. | Behavioural | Passive Heat Therapy |
| Sham ImmersionThe sham intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions. | Behavioural | Sham Immersion |
Primary outcome
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.
5 secondary outcomes
Flow mediated dilation of the superficial femoral artery following chronic passive heat therapy.
Time frame: 6 weeks
Arterial stiffness following chronic passive heat therapy
Time frame: 6 weeks
Exercise tolerance following chronic passive heat therapy
Time frame: 6 weeks
The acute changes in leg blood flow from a single bout of passive heat therapy
Time frame: During procedure: 60-minutes
The acute changes in superficial femoral artery shear stress from a single bout of passive heat therapy
Time frame: During procedure: 60-minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil Eves, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Heat Therapy in people with COPD and Cardiovascular Diseases, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neil Eves, PhD ((250) 807-9676, neil.eves@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 24-hour ambulatory blood pressure following chronic passive heat therapy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.