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

Primary Purpose

Chronic Kidney Disease, End Stage Renal Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SLIMM
Sponsored by
Srinvasan Beddhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stage 1-2 Chronic Kidney Disease

Stage 3-4 Chronic Kidney Disease

Arm Description

Individuals with estimated glomerular filtration rate > 60 mL/min/1.73m^2, to undergo SLIMM intervention

Individuals with estimated glomerular filtration rate 15 to < 60 mL/min/1.73m^2, to undergo SLIMM intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 6, 2014
Last Updated
October 3, 2016
Sponsor
Srinvasan Beddhu
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1. Study Identification

Unique Protocol Identification Number
NCT02924298
Brief Title
Effect of Sit Less, Interact, Move More (SLIMM) Regimen on Patients With Chronic Kidney Disease (CKD)
Acronym
SLIMM
Official Title
Sit Less, Interact, Move More (SLIMM) Intervention Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Srinvasan Beddhu

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
More than one-third of U.S. adults (35.7%) are obese (body mass index (BMI) > 30 kg/m2). In 2008, medical costs associated with obesity were estimated at $147 billion. Furthermore, there is a graded association of BMI and the risk of end stage renal disease (ESRD). Indeed, increasing prevalence of CKD in the US population is partly explained by increasing BMI. Hence, as a public health policy, it is imperative that obesity be targeted in order to decrease the morbidity, mortality and the healthcare costs burden associated with CKD and ESRD. Physical inactivity plays a major role in obesity. Volitional exercise (VE), which includes moderate to vigorous physical activities (MVPA) such as sports and fitness-related activities, and non-volitional exercise, which includes low to light intensity physical activity (PA) such as activities of daily living, fidgeting, spontaneous muscle contraction, and maintaining posture in non-recumbent positions, represent two different ends of the PA spectrum. The current national recommendations are focused on MVPA (30 minutes of moderate PA five times a week or 25 minutes of vigorous activities three times a week). However, the relative importance of low and light activities and MVPA has not been established. As described in the preliminary data, the analyses of objectively measured PA in National Health And Nutrition Examination Survey (NHANES) suggest that a larger amount of light intensity PA is strongly associated with lower odds of proteinuria, lower odds of CKD and a lower hazard of death at any given level of MVPA. Furthermore, there appears to be a threshold effect for MVPA with mortality that plateaus at about half of the currently recommended levels of MVPA. Since physical function in the CKD population is low, 30 minutes of moderate PA five times a week or 25 minutes of vigorous activities three times a week might induce fatigue and paradoxically reduce light intensity PA. On the other hand, a lower target of MVPA might improve adherence with MVPA as well as not decrease light PA. This pilot intervention study will test the efficacy, feasibility and tolerability of the SLIMM intervention. The results of this intervention will be later used to determine if targeting obesity via the SLIMM intervention will slow kidney disease progression. DESIGN: This is a pilot intervention study that will examine the feasibility of and adherence to the SLIMM intervention to increase levels of light physical activity Baseline visit: Baseline PA data will be collected by accelerometer in the week following the screening visit. Participants will be instructed on the importance of physical activity, the recommendations of 150 min/wk of moderate PA, or 75 min/wk of vigorous PA, and be provided with examples of physical activities. SLIMM Intervention: The goal of the SLIMM intervention is to increase the time spent on light activities (Light physical activity is defined as 500-2019 counts/minute). This intervention will only be completed by individuals in the CKD and non-CKD groups. At week 6 of the intervention participants will be instructed to perform 5 minutes of light activity for each 25 minutes of sitting time. At week 12, participants will be instructed to further increase their light activity to a goal of 10 minutes for each 20 minute of sitting time. Thus, the goal is to replace total sedentary time by increase in light activities by 15% in 6 weeks and 33% by the end of the intervention. All participants will undergo standardized training on the SLIMM intervention by trained study personnel at the 6 week visit. Participants will initially be asked to perform 5 minutes of light activity for every 25 minutes spent seated. At the week 12 visit, participants will be asked to further increase their activity, by performing 10 minutes of light activity for every 20 minutes spent seated. Training will be provided in one to one sessions and reinforced at the following visits. Accelerometry data and paper PA diary data collected during the week before the baseline visit will be reviewed with the participant to provide feedback and used for devising a customized plan on increasing light activity. Examples of how to increase light activities within their natural, free-living environment will be provided. For instance, if the majority of their day is spent working at a desk, they will be encouraged to stand and/or walk for 5 minutes for every 25 minutes spent sedentary during weeks 6-12, and 10 minutes of light activity for every 20 minutes spent sedentary for weeks 12-18. Participants will be asked to stand and/or walk during commercial breaks when they are watching television.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1-2 Chronic Kidney Disease
Arm Type
Experimental
Arm Description
Individuals with estimated glomerular filtration rate > 60 mL/min/1.73m^2, to undergo SLIMM intervention
Arm Title
Stage 3-4 Chronic Kidney Disease
Arm Type
Experimental
Arm Description
Individuals with estimated glomerular filtration rate 15 to < 60 mL/min/1.73m^2, to undergo SLIMM intervention
Intervention Type
Behavioral
Intervention Name(s)
SLIMM
Intervention Description
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 Measure Information:
Title
Change in level of light physical activity, measured in minutes per day
Description
Determine the effect of SLIMM intervention as measured by the change in levels of light physical activity, measured by accelerometer
Time Frame
baseline to 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. Are currently receiving chronic maintenance dialysis Have CKD (eGFR 20 to 45 ml/min/1.73 m2 or eGFR > 45 and < 60 ml/min/1.73 m2) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srinivasan Beddhu, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16389251
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. doi: 10.7326/0003-4819-144-1-200601030-00006.
Results Reference
background
PubMed Identifier
17986697
Citation
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. doi: 10.1001/jama.298.17.2038.
Results Reference
background
PubMed Identifier
9880251
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. doi: 10.1126/science.283.5399.212.
Results Reference
background
PubMed Identifier
18651545
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.
Results Reference
background
PubMed Identifier
12588574
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. doi: 10.1046/j.1532-5415.2003.51104.x.
Results Reference
background
PubMed Identifier
12471314
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. doi: 10.1097/00005768-200212000-00027.
Results Reference
background
Links:
URL
http://www.cdc.gov/nchs/data/hestat/obesity_adult_07_08/obesity_adult_07_08.pdf
Description
Center for Disease Control and Prevention: Prevalence of Overweight, Obesity, and Extreme Obesity among Adults: United States Trends 1960-1962 through 2007-2008

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

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