Cerebrovascular Dysregulation in Chronic Kidney Disease

The purpose of this study is to test whether or not regular exercise training may improve brain blood flow regulation in patients with chronic kidney disease (CKD).

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Stretching

Detailed Description

Prior research has shown that CKD patients have an increased risk of stroke and that impairments in brain blood flow regulation predict stroke in other chronic disease states. This study will test whether exercise training can improve brain blood flow regulation via improved dynamic cerebral autoregulation and cerebrovascular carbon dioxide reactivity in CKD. Participants will undergo exercise training on a stationary bicycle, or stretching exercises, 3 times per week for 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Denton, Texas, United States, 76203
      • University of North Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals with chronic kidney disease stages III-IV.

Exclusion Criteria:

• Heart failure
• Chronic obstructive pulmonary disease
• Uncontrolled hypertension or hypotension
• Pregnancy or plans to become pregnant
• Inability to exercise on a stationary bicycle
• Current participation in exercise more than 20 minutes twice per week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Training; Participants will exercise 3 times a week on a stationary bicycle. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) and increase as tolerated to a maximum of 80% of maximal heart rate reserve. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes per session.	Behavioral: Exercise; Participants randomized to this arm will exercise on a stationary bicycle.
Placebo Comparator: Stretching; Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes.	Behavioral: Stretching; Participants randomized to this arm will perform stretching and balance exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Phase (Radians)	Mean arterial pressure was measured via finger photoplethysmography. Middle cerebral artery blood velocity was measured via transcranial Doppler ultrasound. A transfer function analysis was performed on the mean arterial pressure and middle cerebral artery blood velocity data to derive mean arterial pressure-middle cerebral artery blood velocity very low frequency phase (radians)	Mean arterial pressure-middle cerebral artery blood velocity transfer function phase (radians) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13).
Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Gain (cm/s/mmHg)	Mean arterial pressure was measured via finger photoplethysmography. Middle cerebral artery blood velocity data was measured via transcranial Doppler ultrasound. A transfer function analysis was performed on the mean arterial pressure and middle cerebral artery blood velocity data to derive mean arterial pressure-middle cerebral artery blood velocity gain (cm/s/mmHg).	Mean arterial pressure-middle cerebral artery blood velocity transfer function gain (cm/s/mmHg) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13).

Collaborators and Investigators

• Sponsor: University of North Texas, Denton, TX

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: exercise; brain blood flow
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: IRB # 22-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No