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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00792454
First Posted: November 18, 2008
Last Update Posted: May 30, 2017
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.
Information provided by (Responsible Party):
James C Wasserman, Maine Medical Center
  Purpose

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 Intervention
Chronic Kidney Disease End Stage Kidney Disease Cardiovascular Disease Behavioral: exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by James C Wasserman, Maine Medical Center:

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

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

Enrollment: 116
Study Start Date: October 2008
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00792454


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

Responsible Party: James C Wasserman, principal investigator, Maine Medical Center
ClinicalTrials.gov Identifier: NCT00792454     History of Changes
Other Study ID Numbers: 3399
First Submitted: November 14, 2008
First Posted: November 18, 2008
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
Exercise
Cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency