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Lifestyle Modifications and the Progression of Chronic Kidney Disease

Primary Purpose

Patients With Stage 2-4 Chronic Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise training

Diet modification

About this trial

This is an interventional prevention trial for Patients With Stage 2-4 Chronic Kidney Disease focused on measuring CKD

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Stages 2-4 CKD

Exclusion Criteria:

Sites / Locations

Springfield College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle intervention-exercise & diet

Arm Description

Subjects trained for 48 weeks with a personal trainer

Outcomes

Primary Outcome Measures

Glomerular filtration rate (GFR)

GFR was estimated using the MDRD equation, creatinine clearance, urea clearance

Secondary Outcome Measures

24 hour urine protein output

urine protein output is measured before and after 48 weeks of the training program

Full Information

NCT ID

NCT01179906

First Posted

August 10, 2010

Last Updated

August 10, 2010

Sponsor

Springfield College

Collaborators

Western New England Renal & Transplant Associates

1. Study Identification

Unique Protocol Identification Number

NCT01179906

Brief Title

Lifestyle Modifications and the Progression of Chronic Kidney Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Springfield College

Collaborators

Western New England Renal & Transplant Associates

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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. To explore possible mechanisms that could contribute to the observed changes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Stage 2-4 Chronic Kidney Disease

Keywords

CKD

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle intervention-exercise & diet

Arm Type

Experimental

Arm Description

Subjects trained for 48 weeks with a personal trainer

Intervention Type

Behavioral

Intervention Name(s)

Exercise training

Intervention Description

Subjects exercise trained for 48 weeks with personal trainers at a college wellness center

Intervention Type

Behavioral

Intervention Name(s)

Diet modification

Intervention Description

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

Primary Outcome Measure Information:

Title

Glomerular filtration rate (GFR)

Description

GFR was estimated using the MDRD equation, creatinine clearance, urea clearance

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

24 hour urine protein output

Description

urine protein output is measured before and after 48 weeks of the training program

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stages 2-4 CKD Exclusion Criteria: CAD MI

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sam A Headley, Ph.D

Organizational Affiliation

Springfield College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Springfield College

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Lifestyle Modifications and the Progression of Chronic Kidney Disease

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