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Lifestyle Modifications and the Progression of Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Western New England Renal & Transplant Associates
Information provided by:
Springfield College
ClinicalTrials.gov Identifier:
NCT01179906
First received: August 10, 2010
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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 Intervention
Patients With Stage 2-4 Chronic Kidney Disease
 Behavioral: Exercise training
Behavioral: Diet modification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Lifestyle Interventions on the Progression of Kidney Disease in Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Springfield College:

Primary Outcome Measures:
  • Glomerular filtration rate (GFR) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    GFR was estimated using the MDRD equation, creatinine clearance, urea clearance


Secondary Outcome Measures:
  • 24 hour urine protein output [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    urine protein output is measured before and after 48 weeks of the training program


Enrollment: 21
Study Start Date: January 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stages 2-4 CKD

Exclusion Criteria:

  • CAD
  • MI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179906

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

No publications provided

Responsible Party: Samuel Headley, Springfield College
ClinicalTrials.gov Identifier: NCT01179906     History of Changes
Other Study ID Numbers: BHS research incubator study
Study First Received: August 10, 2010
Last Updated: August 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Springfield College:
CKD

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

ClinicalTrials.gov processed this record on June 18, 2013