search
Back to results

Cerebrovascular Dysregulation in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Stretching
Sponsored by
University of North Texas, Denton, TX
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring exercise, brain blood flow

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North TexasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exercise Training

Stretching

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
September 30, 2022
Last Updated
May 8, 2023
Sponsor
University of North Texas, Denton, TX
search

1. Study Identification

Unique Protocol Identification Number
NCT05571605
Brief Title
Cerebrovascular Dysregulation in Chronic Kidney Disease
Official Title
Cerebrovascular Dysregulation in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Texas, Denton, TX

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
exercise, brain blood flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to one of two conditions:1) aerobic exercise training on a stationary bicycle, or 2) stretching and balance training.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants randomized to this arm will exercise on a stationary bicycle.
Intervention Type
Behavioral
Intervention Name(s)
Stretching
Intervention Description
Participants randomized to this arm will perform stretching and balance exercise.
Primary Outcome Measure Information:
Title
change in dynamic cerebral autoregulation
Description
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.
Time Frame
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).
Title
change in cerebrovascular carbon dioxide reactivity
Description
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).
Time Frame
cerebrovascular carbon dioxide reactivity will be compared at baseline (week 0) and after completing the 12-week intervention (week 13).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Sprick, PhD
Phone
940-565-2226
Email
justin.sprick@unt.edu
Facility Information:
Facility Name
University of North Texas
City
Denton
State/Province
Texas
ZIP/Postal Code
76203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Sprick, PhD
Phone
940-565-2226
Email
justin.sprick@unt.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cerebrovascular Dysregulation in Chronic Kidney Disease

We'll reach out to this number within 24 hrs