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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Procedure: Whole-body Passive Heat Therapy (HT); Procedure: Thermoneutral Control (CON)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for participants with CKD:

• Age > 18 years old
• Stage 2-4 CKD

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm: Whole-body Passive Heat Therapy (HT); Heat therapy will be administered using an infrared sauna. The intervention duration will last 25 minutes at a temperature of 60°C.	Procedure: Whole-body Passive Heat Therapy (HT); 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.; Procedure: Thermoneutral Control (CON); Participants will remain in a room temperature environment (22°C) underneath the infrared domes for 25 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal Safety of Heat Therapy	Change in urinary NGAL	Change from baseline to 90 minutes after intervention
Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception	Self reported perception of heat using the the Thermal Sensation Scale.	During 25 minute intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conduit artery endothelial function	Brachial artery flow-mediated dilation assessed by high-resolution duplex ultrasound.	90 minutes after intervention
Lower Limb Microvascular Function	Lower limb microvascular function will be assessed with high-resolution duplex ultrasound during passive leg movement (PLM) technique.	90 minutes after intervention
Exercise Capacity	The 6-minute walk test distance.	90 minutes after intervention

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Danielle Kirkman, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Actual): March 19, 2024
• Study Completion (Actual): March 19, 2024

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: HM20024906; 22-01741 (Other Grant/Funding Number: American College of Sports Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No