Passive Heat Therapy for People With COPD

Sponsor
University of British Columbia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05962164
Collaborator
Canadian Lung Association (Industry)
32
1
2
17
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Passive Heat Therapy
  • Behavioral: Sham Immersion
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel 2-Arm Randomized Control TrialParallel 2-Arm Randomized Control Trial
Masking:
Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
The Acute and Chronic Benefits of Passive Heat Therapy for People With COPD
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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:
  • Lower-leg Hot Water Immersion
  • Footbath
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Mean 24-hour ambulatory blood pressure following chronic passive heat therapy [6 weeks]

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

    Secondary Outcome Measures

    1. Flow mediated dilation of the superficial femoral artery following chronic passive heat therapy. [6 weeks]

      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.

    2. Arterial stiffness following chronic passive heat therapy [6 weeks]

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

    3. Exercise tolerance following chronic passive heat therapy [6 weeks]

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

    4. The acute changes in leg blood flow from a single bout of passive heat therapy [During procedure: 60-minutes]

      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.

    5. The acute changes in superficial femoral artery shear stress from a single bout of passive heat therapy [During procedure: 60-minutes]

      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.

    Other Outcome Measures

    1. The acute change in exercise tolerance following a single bout of PHT vs. the change with sham treatment [~48 hours]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of British Columbia Kelowna British Columbia Canada V1V2L2

    Sponsors and Collaborators

    • University of British Columbia
    • Canadian Lung Association

    Investigators

    • Principal Investigator: Neil Eves, PhD, Associate Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Neil Eves, Professor, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT05962164
    Other Study ID Numbers:
    • H21-01868
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Neil Eves, Professor, University of British Columbia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2023