Passive Heat Therapy for People With COPD (COPD)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; COPD
• Intervention / Treatment: Behavioral: Passive Heat Therapy; Behavioral: Sham Immersion

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neil Eves, PhD; Phone Number: (250) 807-9676; Email: neil.eves@ubc.ca
• Study Contact Backup: Name: Kyla Coates, MSc; Phone Number: (250) 661-7207; Email: kyla.coates@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V2L2
      • Recruiting
      • University of British Columbia
      • Contact: Neil Eves, PhD; Phone Number: 250-807-9676; Email: neil.eves@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; The intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.; Other Names: Footbath; Lower-leg Hot Water Immersion
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; The sham intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Lung Association
• Investigators: Principal Investigator: Neil Eves, PhD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation; Cardiovascular Health; Passive Heat Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: H21-01868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No