Lifestyle Modifications and the Progression of Chronic Kidney Disease

NCT ID: NCT01179906

Last Updated: 2010-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Patients With Stage 2-4 Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lifestyle intervention-exercise & diet

Subjects trained for 48 weeks with a personal trainer

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

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

Diet modification

Intervention Type BEHAVIORAL

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

Interventions

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Exercise training

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

Intervention Type BEHAVIORAL

Diet modification

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Stages 2-4 CKD

Exclusion Criteria

* CAD
* MI
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western New England Renal & Transplant Associates

UNKNOWN

Sponsor Role collaborator

Springfield College

OTHER

Sponsor Role lead

Responsible Party

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Springfield College

Principal Investigators

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Sam A Headley, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Springfield College

Locations

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Springfield College

Springfield, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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BHS research incubator study

Identifier Type: -

Identifier Source: org_study_id

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