Reduction of Mortality Prior to and During the First 90 Days of Dialysis Through a Renal Rehabilitation Program

Not Applicable

Completed

• Conditions: Cardiovascular Disease; End Stage Kidney Disease; Chronic Kidney Disease
• Interventions: Behavioral: exercise training

• Registration Number: NCT00792454
• Lead Sponsor: MaineHealth

Brief Summary

The mortality rate of treated patients with end stage renal disease(ESRD)is 22 deaths patient-years at risk in 2006. Incident patients with ESRD are most vulnerable within the first 90 days of dialysis, with an annualized mortality rate of 50 deaths/100 patient years. The vast majority of these deaths are due to cardiovascular causes. As cardiac rehabilitation programs have shown a 20% reduction in one year overall mortality rate post myocardial infarction the investigator proposes that a similar type of rehabilitation program will also have a benificial effect on morbidity and mortality in patients with chronic kidney disease(CKD)and ESRD.The overall goal of this project is to study whether a renal rehabilitation program based on guided exercise implemented in patients with stage III and stage IV CKD can influence the mortality rate of these patients prior to and during the first 90 days of dialysis

Hypothesis:The application of a guided exercise program (renal rehabilitation) instituted in patients with stage III or Stage IV CKD will decrease the mortality rate prior to the initiation of renal replacement therapy.

Hypothesis:The application of renal rehabilitation during the late stages of CKD will decrease the mortality risk during the first 90 days of renal rehabilitation therapy.

Hypothesis:A guided exercise program will have an immediate and prolonged effect on activity levels, mental health and adaption to chronic illness in patients with advanced CKD.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• greater than 18 yo
• stage III CKD (GFR<60ml/min)
• stage IV CKD (GFR<30ml/min)

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Exclusion Criteria

• active angina pectoris
• lower extremity amputation with no prosthesis
• orthopedic disorder severly exacerbated by activity
• chronic lung disease resulting in significant shortness of breath or oxygen de-saturation at rest
• cerebro cascular disease manifested by ongoing TIAs
• malignant carcinoma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise training/renal rehabilitation	exercise training	Experimental arm will undergo 12 weeks of training in exercise, meditation, and nutrition education.

Primary Outcome Measures

Name	Time	Method
Mortality prior to and During the First 90 Days of Dialysis	5 years

Secondary Outcome Measures

Name	Time	Method
Measurement of physical fitness and quality of life	5 years

Trial Locations

Locations (1)

Maine Nephrology Associates; 🇺🇸 Portland, Maine, United States