Physical Activity in CKD
- Conditions
- Chronic Kidney Diseases
- Interventions
- Behavioral: Increase Physical Activity
- Registration Number
- NCT06624358
- Lead Sponsor
- Children's Hospital of Philadelphia
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
For adolescent participants:
- 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
- Have a condition, such as heart or lung disease, that preclude safely engaging in physical activity
- Have received a solid organ transplant
- Have limited English proficiency
- Are on dialysis
- 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:
- Limited English proficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Ramped Step goals Increase Physical Activity This intervention designed to test if ramped step goals improve physical activity participation. Ramped step goals with feedback Increase Physical Activity This intervention designed to test if ramped step goals and/or daily feedback improve physical activity participation. Ramped step goal with financial incentive Increase Physical Activity This intervention designed to test if ramped step goals and/or financial incentive improve physical activity participation. Ramped step goal with financial incentive and feedback Increase Physical Activity This intervention designed to test if ramped step goals and/or financial incentive and/or daily feedback improve physical activity participation. Fixed step goal only Increase Physical Activity This intervention designed to test if fixed step goals improve physical activity participation. Fixed step goal with feedback Increase Physical Activity This intervention designed to test if fixed step goals and/or daily feed back improve physical activity participation. Fixed step goal with financial incentives Increase Physical Activity This intervention designed to test if fixed step goals and/or financial incentives improve physical activity participation. Fixed step goal with financial incentive and feedback Increase Physical Activity This intervention designed to test if fixed step goals and/or financial incentives and/or daily feedback improve physical activity participation. Personalized plan with fixed step goal Increase Physical Activity This intervention designed to test if personalized exercise plan and/or fixed step goal improves physical activity participation. Personalized plan with fixed step goal and feedback Increase Physical Activity This intervention designed to test if personalized exercise plan and/or fixed step goal and/or daily feedback improves physical activity participation. Personalized plan with fixed step goal and financial incentive Increase Physical Activity This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive improves physical activity participation. Personalized plan with fixed step goal and financial incentive and feedback Increase Physical Activity This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive and/or daily feedback improves physical activity participation. Personalized plan with ramped step goal Increase Physical Activity This intervention designed to test if personalized exercise plan and/or fixed step goal improves physical activity participation. Personalized plan with ramped step goal and feedback Increase Physical Activity This intervention designed to test if personalized exercise plan and/or fixed step goal and/or daily feedback improves physical activity participation. Personalized plan with ramped step goal and financial incentive Increase Physical Activity This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive improves physical activity participation. Personalized plan with ramped step goal and financial incentive and feedback Increase Physical Activity This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive and/or daily feedback improves physical activity participation.
- Primary Outcome Measures
Name Time Method Change in time spent in moderate to vigorous physical activity (minutes/day) pre 12 week intervention and post 12 week intervention Change in time spent in moderate to vigorous physical activity measured by Fitbit over the course of 12 weeks
- Secondary Outcome Measures
Name Time Method Participant feedback at the end of the 12 week intervention At completion of 12 week intervention, participants will complete an exit survey to collect feedback about the participant's experience. This is not scored.
moderate to vigorous physical activity at 6 months 6 months measure moderate to vigorous physical activity by Fitbit 3 months after completion of 12 week intervention
PROMIS Anxiety pre 12 week intervention and post 12 week intervention 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.
PROMIS Depressive Symptoms pre 12 week intervention and post 12 week intervention 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.
PROMIS Positive Affect pre 12 week intervention and post 12 week intervention Patient self-report of 39 items from PROMIS positive affect domain. Participants rate their experience using a five point scale ranging from never to 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.
PROMIS Anger pre 12 week intervention and post 12 week intervention Patient self-report of 9 items from PROMIS anger 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.
PROMIS Psychological Stress Experiences pre 12 week intervention and post 12 week intervention Patient self-report of 19 items from PROMIS stress domain. Participants rate their experience using a five point scale ranging from never to 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.
Change in hand grip strength (age and sex based z-scores) pre 12-week intervention and post 12-week intervention Change in hand grip strength measured by digital hand dynamometer as a age and sex z-score generated from normative data. Z-score is a statistical measurement that describes a values relationship to the mean of a group of values. Values above the mean have positive standard scores, while those below the mean have negative standard scores.
PROMIS Fatigue pre 12 week intervention and post 12 week intervention Patient self-report of 25 items from PROMIS fatigue 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.
PROMIS Sleep Disturbance pre 12 week intervention and post 12 week intervention Patient self-report of 15 items from PROMIS sleep disturbance 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.
PROMIS Sleep-Related Impairment pre 12 week intervention and post 12 week intervention Patient self-report of 13 items from PROMIS sleep-related impairment 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.
PROMIS Life Satisfaction pre 12 week intervention and post 12 week intervention Patient self-report of 42 items from PROMIS life satisfaction 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.