Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease

March 27, 2019 updated by: Aditi Gupta, MD, University of Kansas Medical Center
The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in patients with end stage renal disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients with end stage renal disease have higher cognitive impairment than general population. They also have decreased physical and functional capacity. Exercise has shown to improve cognition in general population. This study will evaluate if exercise improves cognition in dialysis patients. It will also evaluate whether exercise affects performance in daily activities, mood or depression and inflammatory markers in the blood.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with ESRD on dialysis
  • Age greater than 20 years
  • Have means of transportation to and from the exercise session
  • Speak English (as the neuropsychological tests will be performed in English)

Exclusion Criteria:

  • Recent myocardial infarction (within 6 weeks), unstable angina, uncontrolled arrhythmias, congestive heart failure (> NYHA grade II)
  • History of stroke in the last 2 months
  • Active respiratory disease
  • Uncontrolled hypertension
  • Severe uncontrolled diabetes
  • Persistent predialysis hyperkalemia
  • Active decompensated liver disease
  • Symptomatic peripheral vascular disease
  • Musculoskeletal abnormalities that will be prohibit their participation in the exercise program
  • Health conditions needing frequent hospitalizations
  • Other health conditions causing inability to follow exercise program correctly
  • Unwillingness to participate in structured exercise program
  • Current use of antipsychotics or anti-epileptics
  • Inability to hear, read or write which will limit their ability to perform the cognitive tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Group
Subjects randomized to this group will start 12 weeks of supervised aerobic exercise after baseline testing.
Other: Aerobic Exercise
Each exercise session will be conducted at the KUMC Exercise and Cardiovascular Health (REACH) Laboratory. Exercise sessions will include a warm-up period, exercise period and a cool down period. Exercise intervention individualized based on health of participant. Subject will be asked to completed two exercise sessions per week for 12 weeks.
Experimental: Control Group
Subjects randomized to this group will continue with 12 weeks of Standard Care. After 12 weeks, the subjects will cross over to the exercise arm and undergo baseline testing again and then start 12 weeks of exercise intervention.
Other: Aerobic Exercise
Each exercise session will be conducted at the KUMC Exercise and Cardiovascular Health (REACH) Laboratory. Exercise sessions will include a warm-up period, exercise period and a cool down period. Exercise intervention individualized based on health of participant. Subject will be asked to completed two exercise sessions per week for 12 weeks.
Procedure: Standard Care Dialysis
12 weeks of standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: Up to 26 Weeks
Subject compliance with exercise training
Up to 26 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Baseline, within1 week before and within 1 week after exercise intervention
Measured using a standard battery of neuropsychological tests.
Baseline, within1 week before and within 1 week after exercise intervention
Markers of inflammation
Time Frame: Baseline, within 1 week before and within 1 week after exercise intervention
Markers of inflammation will be evaluated before and after exercise intervention
Baseline, within 1 week before and within 1 week after exercise intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Aditi Gupta, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 17, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000284

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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