Passive Heat Therapy for People With COPD

Cardiovascular Diseases Clinical Trial

— COPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962164
• Other study ID #: H21-01868
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of British Columbia
• Contact: Neil Eves, PhD
• Phone: (250) 807-9676
• Email: neil.eves[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• COPD

Intervention

Behavioral:
• Passive Heat Therapy
The intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.
• Sham Immersion
The sham intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.

Locations

Country	Name	City	State
Canada	University of British Columbia	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	~48 hours
Primary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	Arterial stiffness following chronic passive heat therapy	The change in pulse wave velocity (m/s) measured by applanation tonometry from baseline to post intervention.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	During procedure: 60-minutes
Secondary	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.	During procedure: 60-minutes