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Clinical Trials/NCT05924919
NCT05924919CompletedNot Applicable

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

Virginia Commonwealth University1 site in 1 country10 target enrollmentStarted: September 18, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Renal Safety of Heat Therapy

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Experimental

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

Intervention: Whole-body Passive Heat Therapy (HT) (Procedure)

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

Experimental

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

Intervention: Thermoneutral Control (CON) (Procedure)

Outcomes

Primary Outcomes

Renal Safety of Heat Therapy

Time Frame: Change from baseline to 90 minutes after intervention

Change in urinary NGAL

Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception

Time Frame: During 25 minute intervention

Self reported perception of heat using the the Thermal Sensation Scale.

Secondary Outcomes

  • Conduit artery endothelial function(90 minutes after intervention)
  • Lower Limb Microvascular Function(90 minutes after intervention)
  • Exercise Capacity(90 minutes after intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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