Physical Activity in CKD
ConditionChronic Kidney Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorChildren's Hospital of Philadelphia
About this trial
The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females age 13 - 18 years
Diagnosis of CKD stage II - V not yet on dialysis or with a transplant
English proficiency
Parental/guardian permission (informed consent), and if applicable, child assent
Disqualifiers
Pregnant or lactating
Non-ambulatory
Have high physical activity at baseline (>45 min/day of MVPA)
Provide <2 days of physical activity data during the run-in period
Trial design
Design model
Factorial
Treatments tested in this trial
Increase Physical Activity
BehavioralBehavioral interventions to improve physical activity
Treatment groups
100 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Fixed step goal onlyExperimental treatment 1 intervention
Group B: Fixed step goal with feedbackExperimental treatment 1 intervention
Group C: Fixed step goal with financial incentivesExperimental treatment 1 intervention
Group D: Fixed step goal with financial incentive and feedbackExperimental treatment 1 intervention
Group E: Ramped Step goalsExperimental treatment 1 intervention
Group F: Ramped step goals with feedbackExperimental treatment 1 intervention
Group G: Ramped step goal with financial incentiveExperimental treatment 1 intervention
Group H: Ramped step goal with financial incentive and feedbackExperimental treatment 1 intervention
Group I: Personalized plan with fixed step goalExperimental treatment 1 intervention
Group J: Personalized plan with fixed step goal and feedbackExperimental treatment 1 intervention
Group K: Personalized plan with fixed step goal and financial incentiveExperimental treatment 1 intervention
Group L: Personalized plan with fixed step goal and financial incentive and feedbackExperimental treatment 1 intervention
Group M: Personalized plan with ramped step goalExperimental treatment 1 intervention
Group N: Personalized plan with ramped step goal and feedbackExperimental treatment 1 intervention
Group O: Personalized plan with ramped step goal and financial incentiveExperimental treatment 1 intervention
Group P: Personalized plan with ramped step goal and financial incentive and feedbackExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in time spent in moderate to vigorous physical activity (minutes/day)
Change in time spent in moderate to vigorous physical activity measured by Fitbit over the course of 12 weeks
Time frame
pre 12 week intervention and post 12 week interventionSecondary outcomes
1
Participant feedback
At completion of 12 week intervention, participants will complete an exit survey to collect feedback about the participant's experience. This is not scored.
Time frame
at the end of the 12 week intervention2
moderate to vigorous physical activity at 6 months
measure moderate to vigorous physical activity by Fitbit 3 months after completion of 12 week intervention
Time frame
6 months3
PROMIS Anxiety
Patient self-report of 15 items from PROMIS anxiety domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame
pre 12 week intervention and post 12 week intervention4
PROMIS Depressive Symptoms
Patient self-report of 14 items from PROMIS anxiety domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame
pre 12 week intervention and post 12 week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov