Cerebrovascular Dysregulation in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Cerebrovascular Dysregulation in Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571605
• Other study ID #: IRB # 22-305
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: University of North Texas, Denton, TX
• Contact: Justin Sprick, PhD
• Phone: 940-565-2226
• Email: justin.sprick[@]unt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Exercise
Participants randomized to this arm will exercise on a stationary bicycle.
• Stretching
Participants randomized to this arm will perform stretching and balance exercise.

Locations

Country	Name	City	State
United States	University of North Texas	Denton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of North Texas, Denton, TX

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in dynamic cerebral autoregulation	Mean arterial pressure and middle cerebral artery blood velocity data will be subjected to transfer function analysis to derive mean arterial pressure-middle cerebral artery blood velocity transfer function phase (radians) and gain (cm/s/mmHg). These indices reflect dynamic cerebral autoregulation.	Mean arterial pressure-middle cerebral artery blood velocity transfer function phase (radians) and gain (cm/s/mmHg) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13).
Primary	change in cerebrovascular carbon dioxide reactivity	cerebrovascular carbon dioxide reactivity will be quantified as the change in middle cerebral artery blood velocity for a given change in end-tidal CO2 (cm/s/mmHg).	cerebrovascular carbon dioxide reactivity will be compared at baseline (week 0) and after completing the 12-week intervention (week 13).