Lifestyle Modifications and the Progression of Chronic Kidney Disease

August 10, 2010 updated by: Springfield College

Effect of Lifestyle Interventions on the Progression of Kidney Disease in Patients With Chronic Kidney Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Springfield, Massachusetts, United States, 01109
        • Springfield College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stages 2-4 CKD

Exclusion Criteria:

  • CAD
  • MI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular filtration rate (GFR)
Time Frame: 48 weeks
GFR was estimated using the MDRD equation, creatinine clearance, urea clearance
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour urine protein output
Time Frame: 48 weeks
urine protein output is measured before and after 48 weeks of the training program
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Springfield College

Collaborators

Western New England Renal & Transplant Associates

Investigators

  • Principal Investigator: Sam A Headley, Ph.D, Springfield College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Estimate)

August 11, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHS research incubator study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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