Cerebrovascular Dysregulation in Chronic Kidney Disease

NCT05571605 | Completed Results

• 1 other identifier: IRB # 22-305
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Kidney Diseases

Keywords

exercise; brain blood flow

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (2)

Exercise Training

EXPERIMENTAL

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

Stretching

PLACEBO COMPARATOR

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

Interventions

Exercise BEHAVIORAL

Participants randomized to this arm will exercise on a stationary bicycle.

Exercise Training

Stretching BEHAVIORAL

Participants randomized to this arm will perform stretching and balance exercise.

Stretching

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with chronic kidney disease stages III-IV.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Texas, Denton, TX: lead

Study Sites (1)

University of North Texas

Denton, Texas, 76203, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Justin Sprick
• Organization: University of North Texas

justin.sprick@unt.edu

940-565-2226

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be assigned to one of two conditions:1) aerobic exercise training on a stationary bicycle, or 2) stretching and balance training.

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 7, 2022
• Study Start: August 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)