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Completed

NCT Number: NCT05924919

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.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole-body Passive Heat Therapy (HT)

Procedure

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)

Procedure

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

Primary outcomes

  1. Renal Safety of Heat Therapy

    Time frame: 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

    Time frame: During 25 minute intervention

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

Secondary outcomes

  1. Conduit artery endothelial function

    Time frame: 90 minutes after intervention

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

  2. Lower Limb Microvascular Function

    Time frame: 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

    Time frame: 90 minutes after intervention

    The 6-minute walk test distance.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2023
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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