Patients With Stage 2-4 Chronic Kidney Disease Clinical Trial
Official title:
Effect of Lifestyle Interventions on the Progression of Kidney Disease in Patients With Chronic Kidney Disease
| Verified date | January 2006 |
| Source | Springfield College |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | February 2009 |
| Est. primary completion date | February 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Stages 2-4 CKD Exclusion Criteria: - CAD - MI |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Springfield College | Springfield | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Springfield College | Western New England Renal & Transplant Associates |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glomerular filtration rate (GFR) | GFR was estimated using the MDRD equation, creatinine clearance, urea clearance | 48 weeks | No |
| Secondary | 24 hour urine protein output | urine protein output is measured before and after 48 weeks of the training program | 48 weeks | No |