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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00792454
Enrollment
116
Registered
2008-11-18
Start date
2008-10-31
Completion date
2015-11-30
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Chronic Kidney Disease, End Stage Kidney Disease

Keywords

Chronic kidney disease, End stage renal disease, Exercise, Cardiovascular disease

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.

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.

Sponsors

MaineHealth
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Mortality prior to and During the First 90 Days of Dialysis5 years

Secondary

MeasureTime frame
Measurement of physical fitness and quality of life5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026