Cerebrovascular Dysregulation in Chronic Kidney Disease

NCT ID: NCT05571605

Last Updated: 2025-07-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

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.

Group Type PLACEBO_COMPARATOR

Stretching

Intervention Type BEHAVIORAL

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

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Stretching

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Texas, Denton, TX

OTHER

Sponsor Role lead

Responsible Party

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Justin Sprick

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of North Texas

Denton, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB # 22-305

Identifier Type: -

Identifier Source: org_study_id

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