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

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792454
• Other study ID #: 3399
• Status: Completed
• Phase: N/A
• First received: November 14, 2008
• Last updated: May 25, 2017
• Start date: October 2008
• Est. completion date: November 2015

Study information

• Verified date: May 2017
• Source: Maine Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Disease
• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Maine Nephrology Associates	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Maine Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality prior to and During the First 90 Days of Dialysis		5 years
Secondary	Measurement of physical fitness and quality of life		5 years