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NCT Number: NCT06624358

Physical Activity in CKD

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

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For adolescent participants:

  • 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

For caregiver participants:

  • Parent/legal guardian of an enrolled adolescent participant
  • English proficiency

Exclusion criteria

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

Treatment and study plan

Increase Physical Activity

Behavioral

Behavioral interventions to improve physical activity

Primary outcomes

  1. Change in time spent in moderate to vigorous physical activity (minutes/day)

    Time frame: 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 outcomes

  1. Participant feedback

    Time frame: 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.

  2. moderate to vigorous physical activity at 6 months

    Time frame: 6 months

    measure moderate to vigorous physical activity by Fitbit 3 months after completion of 12 week intervention

  3. PROMIS Anxiety

    Time frame: 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.

  4. PROMIS Depressive Symptoms

    Time frame: 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.

  5. PROMIS Positive Affect

    Time frame: 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.

  6. PROMIS Anger

    Time frame: 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.

  7. PROMIS Psychological Stress Experiences

    Time frame: 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.

  8. Change in hand grip strength (age and sex based z-scores)

    Time frame: 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.

  9. PROMIS Fatigue

    Time frame: 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.

  10. PROMIS Sleep Disturbance

    Time frame: 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.

  11. PROMIS Sleep-Related Impairment

    Time frame: 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.

  12. PROMIS Life Satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Kogon, MD MPH

CONTACT

[email protected]

215 590 2449

Jillian LoGuidice, BS

CONTACT

[email protected]

267-425-4541

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Physical Activity in Adolescents With Chronic Kidney Disease

Acronym: PACKD

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 3, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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