Lifestyle Modifications and the Progression of Chronic Kidney Disease

• Sponsor: Springfield College (Other)
• Overall Status: Completed
• CT.gov ID: NCT01179906
• Collaborator: Western New England Renal & Transplant Associates (Other)
• Enrollment: 21
• Location: 1
• Arm: 1
• Duration (Months): 37
• Patients Per Site Per Month: 0.6

Study Details

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:

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2006
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Glomerular filtration rate (GFR) [48 weeks]

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

Secondary Outcome Measures

1. 24 hour urine protein output [48 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stages 2-4 CKD

Exclusion Criteria:

• CAD

• MI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01179906
• Other Study ID Numbers: BHS research incubator study
• First Posted: Aug 11, 2010
• Last Update Posted: Aug 11, 2010
• Last Verified: Jan 1, 2006

• Keywords provided by , ,: CKD
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Aug 11, 2010