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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.
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
History of Changes
  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: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maine Medical Center:

Primary Outcome Measures:
  • Mortality prior to and During the First 90 Days of Dialysis [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of physical fitness and quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2008
Estimated Study Completion Date: November 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792454

Contacts
Contact: James C Wasserman, MD 207-799-8374 wassej@mmc.org

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

No publications provided

Responsible Party: James C Wasserman, principal investigator, Maine Medical Center
ClinicalTrials.gov Identifier: NCT00792454     History of Changes
Other Study ID Numbers: 3399
Study First Received: November 14, 2008
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Maine Medical Center:
Chronic kidney disease
End stage renal disease
Exercise
Cardiovascular disease

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

ClinicalTrials.gov processed this record on May 22, 2013