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CompletedNCT00792454Updated May 30, 2017

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

An interventional study of exercise training in Chronic Kidney Disease, End Stage Kidney Disease and Cardiovascular Disease, sponsored by MaineHealth. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by MaineHealth · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Disease
  • End Stage Kidney Disease
  • Cardiovascular Disease

Keywords

  • Chronic kidney disease
  • End stage renal disease
  • Exercise
  • Cardiovascular disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 116 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

MaineHealth is the lead sponsor of 34 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    exercise training/renal rehabilitation

    Experimental arm will undergo 12 weeks of training in exercise, meditation, and nutrition education.

    Behavioral: exercise training

  • No intervention
    control

    Control co-hort will receive usual chronic kidney disease care and no exercise, meditation or dietary education intervention.

Interventions

  • Behavioralexercise 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.

06

What researchers measure

Primary outcomes

  1. Mortality prior to and During the First 90 Days of Dialysis

    Time frame: 5 years

Secondary outcomes

  1. Measurement of physical fitness and quality of life

    Time frame: 5 years

07

Study locations

1 site
  • Maine Nephrology Associates
    Portland, Maine 04102, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00792454
Lead sponsor
MaineHealth
Responsible party
James C Wasserman (principal investigator, MaineHealth) — Principal investigator
First posted
Nov 18, 2008
Start date
Oct 2008
Primary completion
Nov 2015
Completion
Nov 2015
Last update
May 30, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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