Lifestyle Modifications and the Progression of Chronic Kidney Disease

NCT01179906 | Completed

• 1 other identifier: BHS research incubator study
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Patients With Stage 2-4 Chronic Kidney Disease

Keywords

CKD

Outcome Measures

Primary Outcomes (1)

• Glomerular filtration rate (GFR)

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

  48 weeks

Secondary Outcomes (1)

• 24 hour urine protein output

  48 weeks

Study Arms (1)

Lifestyle intervention-exercise & diet

EXPERIMENTAL

Subjects trained for 48 weeks with a personal trainer

Behavioral: Exercise training; Behavioral: Diet modification

Interventions

Exercise training BEHAVIORAL

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

Lifestyle intervention-exercise & diet

Diet modification BEHAVIORAL

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

Lifestyle intervention-exercise & diet

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stages 2-4 CKD

You may not qualify if:

• CAD

Sponsors & Collaborators

• Springfield College: lead
• Western New England Renal & Transplant Associates: collaborator

Study Sites (1)

Springfield College

Springfield, Massachusetts, 01109, United States

Location

MeSH Terms

Interventions

Exercise; Diet Therapy

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy; Therapeutics

Study Officials

• Sam A Headley, Ph.D

  Springfield College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: January 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 11, 2010

Record last verified: 2006-01

Locations

US (1)