An interventional study of Increasing Physical activity in Chronic Kidney Disease, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 6 Years to 20 Years. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 44 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Increasing Physical activity
Other: Increasing Physical activity
Other: Increasing Physical activity
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.
Change in Physical Activity
Participants will measure physical activity in the form of daily steps using a pedometer
Time frame: Baseline, 12 weeks
| Milestone | CKD Stages 1-4 | ESRD on Dialysis | Kidney Transplant Recipients |
|---|---|---|---|
| Started | 12 | 7 | 25 |
| Completed | 12 | 7 | 25 |
| Not completed | 0 | 0 | 0 |
Participants will measure physical activity in the form of daily steps using a pedometer
| change in steps per day | CKD Stages 1-4 | ESRD on Dialysis | Kidney Transplant Recipients |
|---|---|---|---|
| Change in Physical Activity | 73 (-115 to 262) | -133 (-325 to 58) | 100 (-14 to 208) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CKD Stages 1-4 | — | 0/12 (0%) | 0/12 (0%) |
| ESRD on Dialysis | — | 0/7 (0%) | 0/7 (0%) |
| Kidney Transplant Recipients | — | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | CKD Stages 1-4 | ESRD on Dialysis | Kidney Transplant Recipients | Total |
|---|---|---|---|---|
| Mean | 16 ± 3.6 | 14.7 ± 2.1 | 14.8 ± 3.6 | 15.1 ± 3.4 |
| Sex: Female, Male(Participants) | CKD Stages 1-4 | ESRD on Dialysis | Kidney Transplant Recipients | Total |
|---|---|---|---|---|
| Female | 7 | 4 | 11 | 22 |
| Male | 5 | 3 | 14 | 22 |
| Race/Ethnicity, Customized(participants) | CKD Stages 1-4 | ESRD on Dialysis | Kidney Transplant Recipients | Total |
|---|---|---|---|---|
| Non-Hispanic white | 4 | 1 | 7 | 12 |
| Hispanic | 5 | 3 | 12 | 20 |
| Asian American | 1 | 2 | 5 | 8 |
| African American | 2 | 1 | 1 | 4 |
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco