Physical Activity in CKD (PACKD)

Physical Activity in Adolescents With Chronic Kidney Disease

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: Increase Physical Activity

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jillian LoGuidice, BS; Phone Number: 267-425-4541; Email: loguidicej@chop.edu
• Study Contact Backup: Name: Amy Kogon, MD MPH; Phone Number: 215 590 2449; Email: kogona@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Jill LoGuidice; Phone Number: 267-425-4541; Email: loguidicej@chop.edu
      • Contact: Amy Kogon, MD, MPH; Phone Number: 215-590-2449; Email: kogona@chop.edu
      • Principal Investigator: Amy Kogon, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed step goal only; This intervention designed to test if fixed step goals improve physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Fixed step goal with feedback; This intervention designed to test if fixed step goals and/or daily feed back improve physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Fixed step goal with financial incentives; This intervention designed to test if fixed step goals and/or financial incentives improve physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Fixed step goal with financial incentive and feedback; This intervention designed to test if fixed step goals and/or financial incentives and/or daily feedback improve physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Ramped Step goals; This intervention designed to test if ramped step goals improve physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Ramped step goals with feedback; This intervention designed to test if ramped step goals and/or daily feedback improve physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Ramped step goal with financial incentive; This intervention designed to test if ramped step goals and/or financial incentive improve physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Ramped step goal with financial incentive and feedback; This intervention designed to test if ramped step goals and/or financial incentive and/or daily feedback improve physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Personalized plan with fixed step goal; This intervention designed to test if personalized exercise plan and/or fixed step goal improves physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Personalized plan with fixed step goal and feedback; This intervention designed to test if personalized exercise plan and/or fixed step goal and/or daily feedback improves physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Personalized plan with fixed step goal and financial incentive; This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive improves physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Personalized plan with fixed step goal and financial incentive and feedback; 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.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Personalized plan with ramped step goal; This intervention designed to test if personalized exercise plan and/or fixed step goal improves physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Personalized plan with ramped step goal and feedback; This intervention designed to test if personalized exercise plan and/or fixed step goal and/or daily feedback improves physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Personalized plan with ramped step goal and financial incentive; This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive improves physical activity participation.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity
Experimental: Personalized plan with ramped step goal and financial incentive and feedback; 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.	Behavioral: Increase Physical Activity; Behavioral interventions to improve physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre 12 week intervention and post 12 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at the end of the 12 week intervention
moderate to vigorous physical activity at 6 months	measure moderate to vigorous physical activity by Fitbit 3 months after completion of 12 week intervention	6 months
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.	pre 12 week intervention and post 12 week intervention
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.	pre 12 week intervention and post 12 week intervention
PROMIS Positive Affect	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.	pre 12 week intervention and post 12 week intervention
PROMIS Anger	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.	pre 12 week intervention and post 12 week intervention
PROMIS Psychological Stress Experiences	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.	pre 12 week intervention and post 12 week intervention
Change in hand grip strength (age and sex based z-scores)	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.	pre 12-week intervention and post 12-week intervention
PROMIS Fatigue	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.	pre 12 week intervention and post 12 week intervention
PROMIS Sleep Disturbance	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.	pre 12 week intervention and post 12 week intervention
PROMIS Sleep-Related Impairment	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.	pre 12 week intervention and post 12 week intervention
PROMIS Life Satisfaction	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.	pre 12 week intervention and post 12 week intervention

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Amy Kogon, MD MPH, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: chronic kidney disease; CKD
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: 23-020727; 1K23DK134847-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All demographic (without PHI), summary data from clinical tests, survey data, processed summary of physical activity, and summary data from the participant feedback will be shared. The investigators will provide the approved Institutional Review Board (IRB) study protocol and the Management Operating Procedures (MOPs). The sample case report forms and surveys used in the study will be made available. The data dictionary for the project will also be shared. The software versions used in the collection and processing of data will be preserved. Source codes in STATA format used to process data for data cleaning purposes will be preserved and made available.
• IPD Sharing Time Frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.
• IPD Sharing Access Criteria: Data shall be made available to authorized Arcus users without access restrictions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No