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

Sponsor

MaineHealth (Other)

Overall Status

Completed

CT.gov ID

NCT00792454

Collaborator

(none)

116

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease End Stage Kidney Disease Cardiovascular Disease	Behavioral: exercise training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: exercise training/renal rehabilitation Experimental arm will undergo 12 weeks of training in exercise, meditation, and nutrition education.	Behavioral: exercise training Subjects will undergo renal rehabilitation in the form of guided exercises 2 times per week for 3 months. Subjects will be encouraged to walk for 1 hour on their own a third day of the week.Subjects will receive recommendations for cardiovascular, weight training and stretching exercises. Cardiovascular and strength capabilities of all subjects will be evaluated at the initial session in order to prescribe the appropriate exercise regimen. An exercise physiologist will conduct these evaluations using the Perceived Level of Exertion Subjects will also receive education and practice in mindful meditation and a heart healthy diet. Subjects will be encouraged to continue exercises, meditation, and healthy eating habits after the 3-month in-center program. Subjects will receive follow-up phone calls at 3-month intervals to encourage ongoing exercise, meditation, and healthy diet.
No Intervention: control Control co-hort will receive usual chronic kidney disease care and no exercise, meditation or dietary education intervention.

Arm

Intervention/Treatment

Experimental: exercise training/renal rehabilitation

Experimental arm will undergo 12 weeks of training in exercise, meditation, and nutrition education.

Behavioral: exercise training

Subjects will undergo renal rehabilitation in the form of guided exercises 2 times per week for 3 months. Subjects will be encouraged to walk for 1 hour on their own a third day of the week.Subjects will receive recommendations for cardiovascular, weight training and stretching exercises. Cardiovascular and strength capabilities of all subjects will be evaluated at the initial session in order to prescribe the appropriate exercise regimen. An exercise physiologist will conduct these evaluations using the Perceived Level of Exertion Subjects will also receive education and practice in mindful meditation and a heart healthy diet. Subjects will be encouraged to continue exercises, meditation, and healthy eating habits after the 3-month in-center program. Subjects will receive follow-up phone calls at 3-month intervals to encourage ongoing exercise, meditation, and healthy diet.

No Intervention: control

Control co-hort will receive usual chronic kidney disease care and no exercise, meditation or dietary education intervention.

Outcome Measures

Primary Outcome Measures

Mortality prior to and During the First 90 Days of Dialysis [5 years]

Secondary Outcome Measures

Measurement of physical fitness and quality of life [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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