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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792454
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
James C Wasserman, Maine Medical Center

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2008
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Mortality prior to and During the First 90 Days of Dialysis [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Measurement of physical fitness and quality of life [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792454

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United States, Maine
Maine Nephrology Associates
Portland, Maine, United States, 04102
Sponsors and Collaborators
Maine Medical Center

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Responsible Party: James C Wasserman, principal investigator, Maine Medical Center Identifier: NCT00792454    
Other Study ID Numbers: 3399
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by James C Wasserman, Maine Medical Center:
Chronic kidney disease
End stage renal disease
Cardiovascular disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency