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

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924919
• Other study ID #: HM20024906
• Secondary ID: 22-01741
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Danielle Kirkman, PhD
• Phone: 804-828-1948
• Email: dlkirkman[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.
• Thermoneutral Control (CON)
Participants will remain in a room temperature environment (22°C) underneath the infrared domes for 25 minutes.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Safety of Heat Therapy	Change in urinary NGAL	Change from baseline to 90 minutes after intervention
Primary	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	Conduit artery endothelial function	Brachial artery flow-mediated dilation assessed by high-resolution duplex ultrasound.	90 minutes after intervention
Secondary	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
Secondary	Exercise Capacity	The 6-minute walk test distance.	90 minutes after intervention