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CompletedNCT05924919Updated Oct 10, 2024

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

An interventional study of Whole-body Passive Heat Therapy (HT) and Thermoneutral Control (CON) in Renal Insufficiency, Chronic, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 10 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age > 18 years old
  • Stage 2-4 CKD

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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) · Procedure: Thermoneutral Control (CON)

Interventions

  • ProcedureWhole-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.

  • ProcedureThermoneutral Control (CON)

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

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What researchers measure

Primary outcomes

  1. Renal Safety of Heat Therapy

    Change in urinary NGAL

    Time frame: Change from baseline to 90 minutes after intervention

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

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

    Time frame: During 25 minute intervention

Secondary outcomes

  1. Conduit artery endothelial function

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

    Time frame: 90 minutes after intervention

  2. Lower Limb Microvascular Function

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

    Time frame: 90 minutes after intervention

  3. Exercise Capacity

    The 6-minute walk test distance.

    Time frame: 90 minutes after intervention

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Study locations

1 site
  • Virginia Commonwealth University
    Richmond, Virginia 23220, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05924919
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Jun 29, 2023
Start date
Sep 18, 2023
Primary completion
Mar 19, 2024
Completion
Mar 19, 2024
Last update
Oct 10, 2024

Study contacts

Danielle Kirkman, PhD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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