Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Increasing Physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Physical Activity, Physical Performance, Physical Functioning, CKD, ESRD, Transplant Recipients
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients, male and female, aged 6-20 years.
- Chronic kidney disease stages 2-4 and ESRD on peritoneal dialysis or hemodialysis and kidney transplantation.
- Patients who can follow simple commands.
- English and Spanish speaking only.
Exclusion Criteria:
- Patients hospitalized in the past 1 month.
- Patients hospitalized in the past I month for infection.
- Patients hospitalized in the past 1 month post peritoneal or hemodialysis catheter placement for the first time.
- 1 month after starting renal replacement therapy for the first time.
- 3 months post kidney transplantation.
- In the opinion of the investigator too ill to participate.
- Unwilling to participate.
- Language barrier.
- Patient with any signs of active infection, shortness of breath, trauma or injury to the legs or feet or those undergoing cardiac evaluation.
- Patients unable to verbalize discomfort or developmental delay will not be included.
- Patients with respiratory distress or on oxygen will be excluded.
- Parents or subjects unable to afford transportation for the 2 scheduled visits will also be excluded.
Sites / Locations
- UCSF
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
CKD Stages 1-4
ESRD on Dialysis
Kidney Transplant recipients
Arm Description
Outcomes
Primary Outcome Measures
Change in Physical Activity
Participants will measure physical activity in the form of daily steps using a pedometer
Secondary Outcome Measures
Full Information
NCT ID
NCT01270529
First Posted
January 3, 2011
Last Updated
June 22, 2016
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01270529
Brief Title
Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease
Official Title
Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
5. Study Description
Brief Summary
Hypothesis #1: Most children with CKD stages 2-4, ESRD and kidney transplantation will report participation in physical activity that falls short of recommended levels of physical activity; Children on dialysis will be less active.
Hypothesis #2: Patients will endorse many barriers to physical activity, some of which will be related to their disease or its treatment; those who are less active will endorse more barriers.
Hypothesis #3: Patients will increase their participation in physical activity in response to a pedometer-based 12 week intervention.
Baseline level of physical activity and magnitude of increase in physical activity will be more closely associated with change in physical functioning and performance than stage of kidney disease or type of renal replacement therapy.
Exercise capacity of the child will be measured by the six minute walk test whereby the subject will asked to walk as far as possible in 6 minutes in a straight corridor.
Body fat or body composition will then be measured by Bioelectric Impedance Spectroscopy.
Physical functioning or Health Related Quality of Life will be assessed self reported/ parent proxy reliable and validated questionnaire specifically designed for child with chronic kidney disease called Pediatric Quality of Life Inventory (Peds QL 4.0). Subjects (teens) or parents will also be asked to fill out a questionnaire on barriers to physical activity on their first visit.
Physical activity will be measured in the form of daily steps. The child will wear the pedometer for the first week to assess his/her baseline level of activity. Then the child will continue to wear the pedometer for another 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and motivate the participant.
After 12 weeks of the pedometer-based intervention to increase physical activity, physical performance, body composition and physical functioning (as described above) will be measured once again to assess the effect of increased physical activity on a second visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Physical Activity, Physical Performance, Physical Functioning, CKD, ESRD, Transplant Recipients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CKD Stages 1-4
Arm Type
Experimental
Arm Title
ESRD on Dialysis
Arm Type
Experimental
Arm Title
Kidney Transplant recipients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Increasing Physical activity
Intervention Description
The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
Primary Outcome Measure Information:
Title
Change in Physical Activity
Description
Participants will measure physical activity in the form of daily steps using a pedometer
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients, male and female, aged 6-20 years.
Chronic kidney disease stages 2-4 and ESRD on peritoneal dialysis or hemodialysis and kidney transplantation.
Patients who can follow simple commands.
English and Spanish speaking only.
Exclusion Criteria:
Patients hospitalized in the past 1 month.
Patients hospitalized in the past I month for infection.
Patients hospitalized in the past 1 month post peritoneal or hemodialysis catheter placement for the first time.
1 month after starting renal replacement therapy for the first time.
3 months post kidney transplantation.
In the opinion of the investigator too ill to participate.
Unwilling to participate.
Language barrier.
Patient with any signs of active infection, shortness of breath, trauma or injury to the legs or feet or those undergoing cardiac evaluation.
Patients unable to verbalize discomfort or developmental delay will not be included.
Patients with respiratory distress or on oxygen will be excluded.
Parents or subjects unable to afford transportation for the 2 scheduled visits will also be excluded.
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94122
Country
United States
12. IPD Sharing Statement
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Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease
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