Passive Heat Therapy for People With COPD

NCT05962164 | Recruiting

• 1 other identifier: H21-01868
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Cardiovascular Diseases

Keywords

Passive Heat Therapy; Pulmonary Rehabilitation; Cardiovascular Health

Outcome Measures

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.

  6 weeks

Secondary Outcomes (5)

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

  6 weeks

• Arterial stiffness following chronic passive heat therapy

  6 weeks

• Exercise tolerance following chronic passive heat therapy

  6 weeks

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

  During procedure: 60-minutes

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

  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

  ~48 hours

Study Arms (2)

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.

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.

Behavioral: Sham Immersion

Interventions

Passive Heat Therapy BEHAVIORAL

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

Passive Heat Therapy

Sham Immersion BEHAVIORAL

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

Sham Immersion

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Have resting blood pressure \> 150/95 mmHg
• On supplemental oxygen for hypoxemia.
• Musculoskeletal pain that limits their ability to perform stationary cycling.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Lung Association: collaborator

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V2L2, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neil Eves, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Eves, PhD

CONTACT

(250) 807-9676; neil.eves@ubc.ca

Kyla Coates, MSc

CONTACT

(250) 661-7207; kyla.coates@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of the participant to the condition (heat therapy or sham) is not possible. Data that needs to be analyzed (i.e. ultrasound videos for blood flow and FMD) will be coded by a team member that is not involved in data collection or analysis. The outcomes assessor will be blind to the participant, condition and time point of the file. Breaking of the code will only occur when all data analysis is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel 2-Arm Randomized Control Trial

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 27, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)