Clinical trial NCT06624358: Physical Activity in CKD
Official title: Physical Activity in Adolescents With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney disease
CKD
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A computerized random number generated by the Way to Health platform will assign children to 1 of 16 study conditions for a 12-week intervention period. The study conditions differ with respect to: personalized exercise plan(on vs off), step goals (ramp-up vs fixed), financial incentive (on vs off), and personalized feedback (on vs off). Our design includes one constant: all participants need to self-monitor their physical activity by wearing the FitBit to allow for daily capture of moderate to vigourous physical activity and step counts. The intervention period is therefore designed to test the effectiveness of 4 components, each with two levels, using a factorial design.
Primary purpose: TREATMENT

Brief summary: The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD.

Detailed description: For youth with chronic kidney disease (CKD), cardiovascular disease (CVD) is a leading cause of morbidity and early mortality. Physical activity is a well-recognized determinant of health and quality of life, but, youth with CKD are less physically active than their healthy peers. Identification of effective strategies to increase physical activity in youth with CKD is paramount to improving outcomes. The investigators will test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD. Guided by the Multiphase Optimization Strategy (MOST) framework, an optimization trial will identify intervention components that increase average daily moderate to vigorous physical activity by 15 min/day, a clinically meaningful increase. The components will be grounded in established behavioral change theories and be delivered via Way to Health, a web-based platform, to overcome barriers at the point of clinical care where time and resources are limited.

Eligibility criteria: Inclusion criteria:

For adolescent participants:

1. Males or females age 13 - 18 years
2. Diagnosis of CKD stage II - V not yet on dialysis or with a transplant
3. English proficiency
4. Parental/guardian permission (informed consent), and if applicable, child assent

For caregiver participants:

1. Parent/legal guardian of an enrolled adolescent participant
2. English proficiency

Exclusion Criteria:

For adolescent participants:

1. Pregnant or lactating
2. Non-ambulatory
3. Have high physical activity at baseline (\>45 min/day of MVPA)
4. Provide \<2 days of physical activity data during the run-in period
5. Have a condition, such as heart or lung disease, that preclude safely engaging in physical activity
6. Have received a solid organ transplant
7. Have limited English proficiency
8. Are on dialysis
9. In the opinion of the investigator, are unable to comply with the requirements of the study protocol or are unsuitable for the study for any reason

For caregivers participants:

1. Limited English proficiency

Primary outcomes:
measure: Change in time spent in moderate to vigorous physical activity (minutes/day)
timeFrame: pre 12 week intervention and post 12 week intervention
Secondary outcomes:
measure: Participant feedback
timeFrame: at the end of the 12 week intervention
measure: moderate to vigorous physical activity at 6 months
timeFrame: 6 months
measure: PROMIS Anxiety
timeFrame: pre 12 week intervention and post 12 week intervention
measure: PROMIS Depressive Symptoms
timeFrame: pre 12 week intervention and post 12 week intervention
measure: PROMIS Positive Affect
timeFrame: pre 12 week intervention and post 12 week intervention
measure: PROMIS Anger
timeFrame: pre 12 week intervention and post 12 week intervention
measure: PROMIS Psychological Stress Experiences
timeFrame: pre 12 week intervention and post 12 week intervention
measure: Change in hand grip strength (age and sex based z-scores)
timeFrame: pre 12-week intervention and post 12-week intervention
measure: PROMIS Fatigue
timeFrame: pre 12 week intervention and post 12 week intervention
measure: PROMIS Sleep Disturbance
timeFrame: pre 12 week intervention and post 12 week intervention
measure: PROMIS Sleep-Related Impairment
timeFrame: pre 12 week intervention and post 12 week intervention
measure: PROMIS Life Satisfaction
timeFrame: pre 12 week intervention and post 12 week intervention
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Amy Kogon, MD MPH
role: PRINCIPAL_INVESTIGATOR
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