Trial Outcomes & Findings for Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease (NCT NCT01270529)
NCT ID: NCT01270529
Last Updated: 2016-08-04
Results Overview
Participants will measure physical activity in the form of daily steps using a pedometer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2016-08-04
Participant Flow
Participant milestones
| Measure |
CKD Stages 1-4
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.
|
ESRD on Dialysis
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.
|
Kidney Transplant Recipients
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
7
|
25
|
|
Overall Study
COMPLETED
|
12
|
7
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
CKD Stages 1-4
n=12 Participants
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.
|
ESRD on Dialysis
n=7 Participants
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.
|
Kidney Transplant Recipients
n=25 Participants
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Continuous
|
16 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 3.4 • n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian American
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksParticipants will measure physical activity in the form of daily steps using a pedometer
Outcome measures
| Measure |
CKD Stages 1-4
n=12 Participants
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.
|
ESRD on Dialysis
n=7 Participants
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.
|
Kidney Transplant Recipients
n=25 Participants
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
|
73 change in steps per day
Interval -115.0 to 262.0
|
-133 change in steps per day
Interval -325.0 to 58.0
|
100 change in steps per day
Interval -14.0 to 208.0
|
Adverse Events
CKD Stages 1-4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ESRD on Dialysis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Kidney Transplant Recipients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kirsten Johansen
University of California, San Francisco
Phone: 415-221-4810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place