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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02145702
• Other study ID #: STUDY00000284
• Status: Terminated
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Subject compliance with exercise training	Up to 26 Weeks
Secondary	Cognitive function	Measured using a standard battery of neuropsychological tests.	Baseline, within1 week before and within 1 week after exercise intervention
Secondary	Markers of inflammation	Markers of inflammation will be evaluated before and after exercise intervention	Baseline, within 1 week before and within 1 week after exercise intervention