NCT05924919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

May 25, 2023

Last Update Submit

October 7, 2024

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (2)

  • Renal Safety of Heat Therapy

    Change in urinary NGAL

    Change from baseline to 90 minutes after intervention

  • 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 Outcomes (3)

  • Conduit artery endothelial function

    90 minutes after intervention

  • Lower Limb Microvascular Function

    90 minutes after intervention

  • Exercise Capacity

    90 minutes after intervention

Study Arms (1)

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.

Procedure: Whole-body Passive Heat Therapy (HT)Procedure: Thermoneutral Control (CON)

Interventions

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.

Experimental Arm: Whole-body Passive Heat Therapy (HT)
Thermoneutral Control (CON)PROCEDURE

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23220, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Danielle Kirkman, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 29, 2023

Study Start

September 18, 2023

Primary Completion

March 19, 2024

Study Completion

March 19, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)