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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Maine Medical Center
Sponsor:
Information provided by (Responsible Party):
James C Wasserman, Maine Medical Center
ClinicalTrials.gov Identifier:
NCT00792454
First received: November 14, 2008
Last updated: October 25, 2012
Last verified: October 2012

November 14, 2008
October 25, 2012
October 2008
November 2015   (final data collection date for primary outcome measure)
Mortality prior to and During the First 90 Days of Dialysis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00792454 on ClinicalTrials.gov Archive Site
Measurement of physical fitness and quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Reduction of Mortality Prior to and During the First 90 Days of Dialysis Through a Renal Rehabilitation Program
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Chronic Kidney Disease
  • End Stage Kidney Disease
  • Cardiovascular Disease
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.

  • Experimental: exercise training/renal rehabilitation
    Experimental arm will undergo 12 weeks of training in exercise, meditation, and nutrition education.
    Intervention: Behavioral: exercise training
  • No Intervention: control
    Control co-hort will receive usual chronic kidney disease care and no exercise, meditation or dietary education intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: James C Wasserman, MD 207-799-8374 wassej@mmc.org
United States
 
NCT00792454
3399
No
James C Wasserman, Maine Medical Center
Maine Medical Center
Not Provided
Not Provided
Maine Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP