Reduction of Mortality Prior to and During the First 90 Days of Dialysis Through a Renal Rehabilitation Program
Primary Purpose
Chronic Kidney Disease, End Stage Kidney Disease, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, End stage renal disease, Exercise, Cardiovascular disease
Eligibility 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
Sites / Locations
- Maine Nephrology Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
exercise training/renal rehabilitation
control
Arm Description
Experimental arm will undergo 12 weeks of training in exercise, meditation, and nutrition education.
Control co-hort will receive usual chronic kidney disease care and no exercise, meditation or dietary education intervention.
Outcomes
Primary Outcome Measures
Mortality prior to and During the First 90 Days of Dialysis
Secondary Outcome Measures
Measurement of physical fitness and quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00792454
Brief Title
Reduction of Mortality Prior to and During the First 90 Days of Dialysis Through a Renal Rehabilitation Program
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MaineHealth
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End Stage Kidney Disease, Cardiovascular Disease
Keywords
Chronic kidney disease, End stage renal disease, Exercise, Cardiovascular disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise training/renal rehabilitation
Arm Type
Experimental
Arm Description
Experimental arm will undergo 12 weeks of training in exercise, meditation, and nutrition education.
Arm Title
control
Arm Type
No Intervention
Arm Description
Control co-hort will receive usual chronic kidney disease care and no exercise, meditation or dietary education intervention.
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality prior to and During the First 90 Days of Dialysis
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Measurement of physical fitness and quality of life
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Maine Nephrology Associates
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reduction of Mortality Prior to and During the First 90 Days of Dialysis Through a Renal Rehabilitation Program
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