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Effect of Sit Less, Interact, Move More (SLIMM) Regimen on Patients With Chronic Kidney Disease (CKD) (SLIMM)

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ClinicalTrials.gov Identifier: NCT02924298
Recruitment Status : Terminated (Lack of funding)
First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease End Stage Renal Disease Behavioral: SLIMM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sit Less, Interact, Move More (SLIMM) Intervention Pilot Study
Study Start Date : September 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Stage 1-2 Chronic Kidney Disease
Individuals with estimated glomerular filtration rate > 60 mL/min/1.73m^2, to undergo SLIMM intervention
Behavioral: SLIMM
Participants will perform 5 minutes of light activity for every 25 minutes spent seated for 12 weeks. Following the week 12 visit, participants will increase light activity to 10 minutes for every 20 minutes spent seated.

Experimental: Stage 3-4 Chronic Kidney Disease
Individuals with estimated glomerular filtration rate 15 to < 60 mL/min/1.73m^2, to undergo SLIMM intervention
Behavioral: SLIMM
Participants will perform 5 minutes of light activity for every 25 minutes spent seated for 12 weeks. Following the week 12 visit, participants will increase light activity to 10 minutes for every 20 minutes spent seated.




Primary Outcome Measures :
  1. Change in level of light physical activity, measured in minutes per day [ Time Frame: baseline to 18 weeks ]
    Determine the effect of SLIMM intervention as measured by the change in levels of light physical activity, measured by accelerometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924298


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Srinvasan Beddhu
Investigators
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Principal Investigator: Srinivasan Beddhu, MD University of Utah
Additional Information:
Publications:
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Responsible Party: Srinvasan Beddhu, MD, University of Utah
ClinicalTrials.gov Identifier: NCT02924298    
Other Study ID Numbers: IRB_00063835
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency