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Behavioral Intervention
Passive Heat Therapy for COPD (COPD Trial)
N/A
Recruiting
Led By Neil Eves, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure: 60-minutes
Awards & highlights
COPD Trial Summary
This trial tests if hot-water footbaths can help people w/ COPD improve their heart health & reduce blood pressure, by increasing leg blood-flow.
Who is the study for?
This trial is for people over 40 with moderate-to-severe COPD who haven't smoked recently and have been stable for at least 6 weeks. It's not for those on Beta Blockers, in exercise programs, with advanced heart or brain vessel disease, uncontrolled high blood pressure, very low blood pressure, or those frequently using hot baths or saunas.Check my eligibility
What is being tested?
The study tests if Passive Heat Therapy (45-minute hot-water footbaths) can improve leg blood-flow and reduce heart disease risk in COPD patients. Over six weeks, the effects of regular footbaths are compared to Sham Immersion (a fake treatment) to see if there are benefits similar to exercising.See study design
What are the potential side effects?
Potential side effects may include discomfort from heat exposure such as sweating or dizziness during the footbath sessions. Long-term side effects are unknown but could involve changes in blood pressure.
COPD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during procedure: 60-minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure: 60-minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean 24-hour ambulatory blood pressure following chronic passive heat therapy
Secondary outcome measures
Arterial stiffness following chronic passive heat therapy
Exercise tolerance following chronic passive heat therapy
Flow mediated dilation of the superficial femoral artery following chronic passive heat therapy.
+2 moreOther outcome measures
The acute change in exercise tolerance following a single bout of PHT vs. the change with sham treatment
COPD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Passive Heat TherapyExperimental Treatment1 Intervention
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.
Group II: Sham ImmersionPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,467,086 Total Patients Enrolled
Canadian Lung AssociationIndustry Sponsor
9 Previous Clinical Trials
65,633 Total Patients Enrolled
Neil Eves, PhDPrincipal InvestigatorAssociate Professor
2 Previous Clinical Trials
83 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 40, don't smoke, and have severe COPD.I am currently taking beta blockers.I have a history of serious heart or stroke issues.My blood pressure is not higher than 160/95 mmHg.I use extra oxygen because I have low blood oxygen levels.I regularly use a hot tub, sauna, or take long hot baths more than once a week.My muscle or joint pain stops me from being able to do stationary cycling.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Immersion
- Group 2: Passive Heat Therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this clinical trial currently open?
"Clinicaltrials.gov states that this trial, which was posted on August 1st 2023 and last updated July 18th 2023, is no longer actively recruiting patients. Nevertheless, 734 other trials are currently seeking participants at the moment."
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