Physical Activity in CKD

Официальное название

Physical Activity in Adolescents With Chronic Kidney Disease

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Increase Physical Activity
  Behavioral interventions to improve physical activity

Первичные конечные точки

• Change in time spent in moderate to vigorous physical activity (minutes/day) [Срок оценки: pre 12 week intervention and post 12 week intervention]

Вторичные конечные точки (12)

• Participant feedback [Срок оценки: at the end of the 12 week intervention]
• moderate to vigorous physical activity at 6 months [Срок оценки: 6 months]
• PROMIS Anxiety [Срок оценки: pre 12 week intervention and post 12 week intervention]
• PROMIS Depressive Symptoms [Срок оценки: pre 12 week intervention and post 12 week intervention]
• PROMIS Positive Affect [Срок оценки: pre 12 week intervention and post 12 week intervention]
• PROMIS Anger [Срок оценки: pre 12 week intervention and post 12 week intervention]
• PROMIS Psychological Stress Experiences [Срок оценки: pre 12 week intervention and post 12 week intervention]
• Change in hand grip strength (age and sex based z-scores) [Срок оценки: pre 12-week intervention and post 12-week intervention]
• PROMIS Fatigue [Срок оценки: pre 12 week intervention and post 12 week intervention]
• PROMIS Sleep Disturbance [Срок оценки: pre 12 week intervention and post 12 week intervention]
• PROMIS Sleep-Related Impairment [Срок оценки: pre 12 week intervention and post 12 week intervention]
• PROMIS Life Satisfaction [Срок оценки: pre 12 week intervention and post 12 week intervention]

Критерии участия

Критерии включения

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

Критерии исключения

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:

1\. Limited English proficiency

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Hospital of Philadelphia — Philadelphia

Публикации

• Mitchell JA, Dowda M, Pate RR, Kordas K, Froberg K, Sardinha LB, Kolle E, Page A. Physical Activity and Pediatric Obesity: A Quantile Regression Analysis. Med Sci Sports Exerc. 2017 Mar;49(3):466-473. doi: 10.1249/MSS.0000000000001129. PMID 27755284
• Clark SL, Denburg MR, Furth SL. Physical activity and screen time in adolescents in the chronic kidney disease in children (CKiD) cohort. Pediatr Nephrol. 2016 May;31(5):801-8. doi: 10.1007/s00467-015-3287-z. Epub 2015 Dec 18. PMID 26684326
• Fedele DA, Cushing CC, Fritz A, Amaro CM, Ortega A. Mobile Health Interventions for Improving Health Outcomes in Youth: A Meta-analysis. JAMA Pediatr. 2017 May 1;171(5):461-469. doi: 10.1001/jamapediatrics.2017.0042. PMID 28319239
• Rose T, Barker M, Maria Jacob C, Morrison L, Lawrence W, Strommer S, Vogel C, Woods-Townsend K, Farrell D, Inskip H, Baird J. A Systematic Review of Digital Interventions for Improving the Diet and Physical Activity Behaviors of Adolescents. J Adolesc Health. 2017 Dec;61(6):669-677. doi: 10.1016/j.jadohealth.2017.05.024. Epub 2017 Aug 16. PMID 28822682
• Groothoff JW, Gruppen MP, Offringa M, Hutten J, Lilien MR, Van De Kar NJ, Wolff ED, Davin JC, Heymans HS. Mortality and causes of death of end-stage renal disease in children: a Dutch cohort study. Kidney Int. 2002 Feb;61(2):621-9. doi: 10.1046/j.1523-1755.2002.00156.x. PMID 11849405
• McDonald SP, Craig JC; Australian and New Zealand Paediatric Nephrology Association. Long-term survival of children with end-stage renal disease. N Engl J Med. 2004 Jun 24;350(26):2654-62. doi: 10.1056/NEJMoa031643. PMID 15215481
• Mitsnefes MM, Laskin BL, Dahhou M, Zhang X, Foster BJ. Mortality risk among children initially treated with dialysis for end-stage kidney disease, 1990-2010. JAMA. 2013 May 8;309(18):1921-9. doi: 10.1001/jama.2013.4208. PMID 23645144
• Laskin BL, Mitsnefes MM, Dahhou M, Zhang X, Foster BJ. The mortality risk with graft function has decreased among children receiving a first kidney transplant in the United States. Kidney Int. 2015 Mar;87(3):575-83. doi: 10.1038/ki.2014.342. Epub 2014 Oct 15. PMID 25317931

Идентификаторы

NCT: NCT06624358 · 23-020727 · 1K23DK134847-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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