Chronic Kidney DiseaseSLIMMNCT02924298
Effect of Sit Less, Interact, Move More (SLIMM) Regimen on Patients With Chronic Kidney Disease (CKD)
A study testing SLIMM in people with Chronic Kidney Disease and End Stage Renal Disease, run by Srinvasan Beddhu at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, End Stage Renal Disease
- What is being tested?
- SLIMM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sit Less, Interact, Move More (SLIMM) Intervention Pilot Study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Being tested
- SLIMM
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLIMMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1-2 Chronic Kidney Disease | Experimental | Individuals with estimated glomerular filtration rate > 60 mL/min/1.73m^2, to undergo SLIMM intervention Receives: Behavioral: SLIMM |
| Stage 3-4 Chronic Kidney Disease | Experimental | Individuals with estimated glomerular filtration rate 15 to < 60 mL/min/1.73m^2, to undergo SLIMM intervention Receives: Behavioral: SLIMM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2013
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Srinvasan Beddhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Srinvasan Beddhu, University of Utah
- Investigators
- Srinivasan Beddhu, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924298
- Sponsor's protocol ID
- IRB_00063835
- Acronym
- SLIMM
- Status last verified
- Oct 2016
- First submitted
- 6 Jan 2014
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16389251Coresh 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.
PubMed 17986697Levine 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.
PubMed 9880251Padilla 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.
PubMed 18651545Studenski 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.
PubMed 12588574Tudor-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.
PubMed 12471314
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sit Less, Interact, Move More (SLIMM) Intervention Pilot Study
- ClinicalTrials.gov ID
- NCT02924298
- Acronym / sponsor ID
- SLIMM / IRB_00063835
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Srinvasan BeddhuUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1-2 Chronic Kidney Disease | Experimental | Behavioral: SLIMMIndividuals with estimated glomerular filtration rate > 60 mL/min/1.73m^2, to undergo SLIMM intervention |
| Stage 3-4 Chronic Kidney Disease | Experimental | Behavioral: SLIMMIndividuals with estimated glomerular filtration rate 15 to < 60 mL/min/1.73m^2, to undergo SLIMM intervention |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be willing to participate in all study procedures and meet the criteria for one of the three groups listed below.
Key exclusion criteria (10 listed)
- Age less than 18 years
- Pregnant women
- Prisoners
- Diagnosis of glomerulonephritis
- Life expectancy less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLIMMParticipants 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. | Behavioural | Stage 1-2 Chronic Kidney Disease, Stage 3-4 Chronic Kidney Disease |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Background: PubMed 16389251Hsu 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.
- Background: PubMed 17986697Coresh 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.
- Background: PubMed 9880251Levine 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.
- Background: PubMed 18651545Padilla 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.
- Background: PubMed 12588574Studenski 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.
- Background: PubMed 12471314Tudor-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivasan Beddhu, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLIMM in people with Chronic Kidney Disease and End Stage Renal Disease, run by Srinvasan Beddhu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of light physical activity, measured in minutes per day (time frame: baseline to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924298, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.