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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05924919
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Whole-body Passive Heat Therapy (HT)
  • Procedure: Thermoneutral Control (CON)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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.
Active Comparator: Control Arm: Thermoneutral Control (CON)

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.

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

Outcome Measures

Primary Outcome Measures

  1. Renal Safety of Heat Therapy [Change from baseline to 90 minutes after intervention]

    Change in urinary NGAL

  2. Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception [During 25 minute intervention]

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

Secondary Outcome Measures

  1. Conduit artery endothelial function [90 minutes after intervention]

    Brachial artery flow-mediated dilation assessed by high-resolution duplex ultrasound.

  2. Lower Limb Microvascular Function [90 minutes after intervention]

    Lower limb microvascular function will be assessed with high-resolution duplex ultrasound during passive leg movement (PLM) technique.

  3. Exercise Capacity [90 minutes after intervention]

    The 6-minute walk test distance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23220

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT05924919
Other Study ID Numbers:
  • HM20024906
  • 22-01741
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

Study Results

No Results Posted as of Jun 29, 2023