Chronic Kidney Disease Clinical Trial
— SLIMMOfficial title:
Sit Less, Interact, Move More (SLIMM) Intervention Pilot Study
Verified date | October 2016 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
In the past two decades, the prevalence of obesity in the US has increased from 23.2% to 32.9%. This epidemic is fueling the Chronic Kidney Disease (CKD) epidemic. This likely is the major challenge facing the nephrology community in the next decade and beyond. This pilot study is designed to test the feasibility of the Sit Less, Interact, Move More (SLIMM) intervention and to determine its preliminary impact on light physical activity (PA) levels. Increasing light PA may have significant impact on both obesity and slowing the progression of CDK.
Status | Terminated |
Enrollment | 32 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 95 Years |
Eligibility |
Inclusion Criteria: - Participants must be willing to participate in all study procedures and meet the criteria for one of the three groups listed below. 1. Are currently receiving chronic maintenance dialysis 2. Have CKD (eGFR 20 to 45 ml/min/1.73 m2 or eGFR > 45 and < 60 ml/min/1.73 m2) 3. Individuals with eGFR >60 ml/min/1.73 m2 Exclusion Criteria: - Age less than 18 years - Pregnant women - Prisoners - Diagnosis of glomerulonephritis - Life expectancy less than 1 year - Expected to undergo renal replacement therapy within 1 year - Enrolled in interventional trials using drugs or devices - Physical mobility limitations that preclude physical activity interventions - Individuals who are wheelchair bound, reliant on a walker or crutches for ambulation - Patients who self-report MVOA greater than 150 min/week or more |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Srinvasan Beddhu |
United States,
Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. — View Citation
Hsu CY, McCulloch CE, Iribarren C, Darbinian J, Go AS. Body mass index and risk for end-stage renal disease. Ann Intern Med. 2006 Jan 3;144(1):21-8. — View Citation
Levine JA, Eberhardt NL, Jensen MD. Role of nonexercise activity thermogenesis in resistance to fat gain in humans. Science. 1999 Jan 8;283(5399):212-4. — View Citation
Padilla J, Krasnoff J, Da Silva M, Hsu CY, Frassetto L, Johansen KL, Painter P. Physical functioning in patients with chronic kidney disease. J Nephrol. 2008 Jul-Aug;21(4):550-9. — View Citation
Studenski S, Perera S, Wallace D, Chandler JM, Duncan PW, Rooney E, Fox M, Guralnik JM. Physical performance measures in the clinical setting. J Am Geriatr Soc. 2003 Mar;51(3):314-22. — View Citation
Tudor-Locke C, Ainsworth BE, Thompson RW, Matthews CE. Comparison of pedometer and accelerometer measures of free-living physical activity. Med Sci Sports Exerc. 2002 Dec;34(12):2045-51. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in level of light physical activity, measured in minutes per day | Determine the effect of SLIMM intervention as measured by the change in levels of light physical activity, measured by accelerometer | baseline to 18 weeks | No |
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