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Procedure
Passive Heat Therapy for Chronic Kidney Disease
N/A
Recruiting
Led By Danielle Kirkman, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years old
Stage 2-4 CKD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes after intervention
Awards & highlights
Summary
This trial investigates the effects of far-infrared therapy on vascular & renal function in CKD patients, hypothesizing improved function & exercise capacity without kidney injury.
Who is the study for?
This trial is for adults over 18 with moderate to severe chronic kidney disease (stages 2-4). Participants should be matched in age and sex to others in the study. It's not specified who can't join, but typically those with conditions that could interfere with the treatment or skew results are excluded.
What is being tested?
The study tests if a single session of whole-body passive heat therapy using far-infrared technology can improve blood vessel function and exercise capacity without harming the kidneys more in people with chronic kidney disease.
What are the potential side effects?
While specific side effects aren't listed, passive heat therapy may cause discomfort like sweating or overheating. It's designed to be well-tolerated, so serious side effects are unlikely but monitoring for any impact on kidney health is crucial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
My kidney function is reduced but not severely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 minutes after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes after intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Renal Safety of Heat Therapy
Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception
Secondary study objectives
Conduit artery endothelial function
Exercise Capacity
Lower Limb Microvascular Function
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm: Whole-body Passive Heat Therapy (HT)Experimental Treatment1 Intervention
Heat therapy will be administered using an infrared sauna. The intervention duration will last 25 minutes at a temperature of 60°C.
Group II: Control Arm: Thermoneutral Control (CON)Active Control1 Intervention
The control arm will consist of 25 minutes in a thermoneutral environment to serve as a comparator condition. Participants will be exposed to the exact conditions as the intervention arm, however, the temperature of exposure will be 22°C.
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Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
710 Previous Clinical Trials
22,886,907 Total Patients Enrolled
Danielle Kirkman, PhDPrincipal InvestigatorVirginia Commonwealth University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.My kidney function is reduced but not severely.My age and sex match the chronic kidney disease study group.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm: Whole-body Passive Heat Therapy (HT)
- Group 2: Control Arm: Thermoneutral Control (CON)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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