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The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease

Primary Purpose

Renal Insufficiency, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole-body Passive Heat Therapy (HT)
Thermoneutral Control (CON)
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for participants with CKD: Age > 18 years old Stage 2-4 CKD Inclusion Criteria for healthy participants: Age > 18 years old Matched in age and sex to the CKD sample Exclusion Criteria for participants with CKD: Unstable medical conditions characterized by frequent or unpredictable biological, chemical, or psychological changes Uncontrolled hypertension Current fluid restrictions End stage kidney disease or currently on dialysis treatment Body weight < 40kg Exhibits any contraindications to exercise as per ACSM guidelines Regular tobacco and/or nicotine use History of heat-related illness Participates in regular exercise and/or sauna use Current hormone replacement therapy Pacemaker or electro-medical implant Persons with or at risk of intestinal disorders including gastroporesis History of diverticula Persons who have undergone surgical procedures in the GI tract Swallowing disorders Chron's disease Current pregnancy Inability to provide informed consent Exclusion Criteria for healthy participants: Current chronic disease Current hormone replacement therapy Body weight < 40kg Exhibits any contraindications to exercise as per ACSM guidelines History of heat-related illness Pacemaker or electro-medical implant Persons with or at risk of intestinal disorders including gastroporesis History of diverticula Persons who have undergone surgical procedures in the GI tract Swallowing disorders Chron's disease Current pregnancy Inability to provide informed consent

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm: Whole-body Passive Heat Therapy (HT)

Control Arm: Thermoneutral Control (CON)

Arm Description

Heat therapy will be administered using an infrared sauna. The intervention duration will last 25 minutes at a temperature of 60°C.

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.

Outcomes

Primary Outcome Measures

Renal Safety of Heat Therapy
Change in urinary NGAL
Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception
Self reported perception of heat using the the Thermal Sensation Scale.

Secondary Outcome Measures

Conduit artery endothelial function
Brachial artery flow-mediated dilation assessed by high-resolution duplex ultrasound.
Lower Limb Microvascular Function
Lower limb microvascular function will be assessed with high-resolution duplex ultrasound during passive leg movement (PLM) technique.
Exercise Capacity
The 6-minute walk test distance.

Full Information

First Posted
May 25, 2023
Last Updated
August 29, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05924919
Brief Title
The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease
Official Title
The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this proposal is to investigate the acute effects of whole-body passive heat therapy using far-infrared technology on vascular function, exercise capacity, and renal function in CKD patients. The central hypothesis is that an acute bout of whole-body passive heat therapy will be well-tolerated and lead to acute improvements in large blood vessel (macrovascular) function, small blood vessel (microvascular) function, and exercise capacity without significantly altering markers of acute kidney injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm: Whole-body Passive Heat Therapy (HT)
Arm Type
Experimental
Arm Description
Heat therapy will be administered using an infrared sauna. The intervention duration will last 25 minutes at a temperature of 60°C.
Arm Title
Control Arm: Thermoneutral Control (CON)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Whole-body Passive Heat Therapy (HT)
Intervention Description
The whole-body passive heat therapy (HT) intervention will consist of an acute bout of infrared sauna for 25 minutes at 60°C. Participants will lie supine on a memory foam pad.
Intervention Type
Procedure
Intervention Name(s)
Thermoneutral Control (CON)
Intervention Description
Participants will remain in a room temperature environment (22°C) underneath the infrared domes for 25 minutes.
Primary Outcome Measure Information:
Title
Renal Safety of Heat Therapy
Description
Change in urinary NGAL
Time Frame
Change from baseline to 90 minutes after intervention
Title
Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception
Description
Self reported perception of heat using the the Thermal Sensation Scale.
Time Frame
During 25 minute intervention
Secondary Outcome Measure Information:
Title
Conduit artery endothelial function
Description
Brachial artery flow-mediated dilation assessed by high-resolution duplex ultrasound.
Time Frame
90 minutes after intervention
Title
Lower Limb Microvascular Function
Description
Lower limb microvascular function will be assessed with high-resolution duplex ultrasound during passive leg movement (PLM) technique.
Time Frame
90 minutes after intervention
Title
Exercise Capacity
Description
The 6-minute walk test distance.
Time Frame
90 minutes after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for participants with CKD: Age > 18 years old Stage 2-4 CKD Inclusion Criteria for healthy participants: Age > 18 years old Matched in age and sex to the CKD sample Exclusion Criteria for participants with CKD: Unstable medical conditions characterized by frequent or unpredictable biological, chemical, or psychological changes Uncontrolled hypertension Current fluid restrictions End stage kidney disease or currently on dialysis treatment Body weight < 40kg Exhibits any contraindications to exercise as per ACSM guidelines Regular tobacco and/or nicotine use History of heat-related illness Participates in regular exercise and/or sauna use Current hormone replacement therapy Pacemaker or electro-medical implant Persons with or at risk of intestinal disorders including gastroporesis History of diverticula Persons who have undergone surgical procedures in the GI tract Swallowing disorders Chron's disease Current pregnancy Inability to provide informed consent Exclusion Criteria for healthy participants: Current chronic disease Current hormone replacement therapy Body weight < 40kg Exhibits any contraindications to exercise as per ACSM guidelines History of heat-related illness Pacemaker or electro-medical implant Persons with or at risk of intestinal disorders including gastroporesis History of diverticula Persons who have undergone surgical procedures in the GI tract Swallowing disorders Chron's disease Current pregnancy Inability to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Kirkman, PhD
Phone
804-828-1948
Email
dlkirkman@vcu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico Chavez, MS
Phone
208-219-4012
Email
chavezda@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Kirkman, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Kirkman, PhD
Phone
804-828-1948
Email
dkirkman@vcu.edu
First Name & Middle Initial & Last Name & Degree
Danielle Kirkman, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease

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