Lifestyle Modifications and the Progression of Chronic Kidney Disease

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. Identifier: NCT01179906
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
Western New England Renal & Transplant Associates
Information provided by:
Springfield College

Brief Summary:

Aerobic training has been shown to favorably alter several of the known risk factors for coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It seems logical that if these risk factors were aggressively controlled in patients with chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise training) to support the pharmacologic interventions that are necessary for the control of the disease, then the rate of progression of the disease may be altered. However, to date, there is no clear research evidence to support this hypothesis. Therefore the aims of the proposed study are:

  1. To test the hypothesis that lifestyle interventions (i.e., dietary modification and regular, long-term aerobic exercise training) will favorably alter the natural progression of CKD in a sample of patients compared to a control group who will receive the current standard care.
  2. To explore possible mechanisms that could contribute to the observed changes.

Condition or disease Intervention/treatment Phase
Patients With Stage 2-4 Chronic Kidney Disease Behavioral: Exercise training Behavioral: Diet modification Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Lifestyle Interventions on the Progression of Kidney Disease in Patients With Chronic Kidney Disease
Study Start Date : January 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lifestyle intervention-exercise & diet
Subjects trained for 48 weeks with a personal trainer
Behavioral: Exercise training
Subjects exercise trained for 48 weeks with personal trainers at a college wellness center

Behavioral: Diet modification
Exercise training using personal trainers 3 times per week. Individuals were trained at a moderate intensity

Primary Outcome Measures :
  1. Glomerular filtration rate (GFR) [ Time Frame: 48 weeks ]
    GFR was estimated using the MDRD equation, creatinine clearance, urea clearance

Secondary Outcome Measures :
  1. 24 hour urine protein output [ Time Frame: 48 weeks ]
    urine protein output is measured before and after 48 weeks of the training program

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stages 2-4 CKD

Exclusion Criteria:

  • CAD
  • MI

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 identifier (NCT number): NCT01179906

United States, Massachusetts
Springfield College
Springfield, Massachusetts, United States, 01109
Sponsors and Collaborators
Springfield College
Western New England Renal & Transplant Associates
Principal Investigator: Sam A Headley, Ph.D Springfield College

Responsible Party: Samuel Headley, Springfield College Identifier: NCT01179906     History of Changes
Other Study ID Numbers: BHS research incubator study
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: January 2006

Keywords provided by Springfield College:

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