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

NCT ID: NCT02145702

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-12-31

Brief Summary

The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in patients with end stage renal disease.

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.

Conditions

Cognitive Impairment; End-Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Group

Subjects randomized to this group will start 12 weeks of supervised aerobic exercise after baseline testing.

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: OTHER

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.

Standard Care Dialysis

Intervention Type: PROCEDURE

12 weeks of standard of care.

Interventions

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.

Intervention Type: OTHER

Standard Care Dialysis

12 weeks of standard of care.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Aditi Gupta, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aditi Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00000284

Identifier Type: -

Identifier Source: org_study_id