Reference Values for Lower-Limb Dynamometry in Patients With Chronic Kidney Disease (REHAD-CKD)

Обзор

Patients with chronic kidney disease (CKD) undergoing hemodialysis present musculoskeletal complications, such as sarcopenia, which impair their functionality and are associated with an increased risk of mortality. Functional assessment in this population is complex due to the organization of hemodialysis schedules and patients' dependence on medical transportation, which hinders evaluation outside the dialysis setting. The assessment of lower limb strength is of great relevance, as an adequate level of muscle strength in this region is essential for performing many activities of daily living, including walking, sit-to-stand and stand-to-sit movements, as well as ascending and descending stairs. Our research group has published a study demonstrating the safety and reliability of intradialytic measurement of hip flexion and abduction strength; however, reference values for the dialysis population and for individuals with CKD in general are currently unknown. The primary aim of this study is to propose reference values for hip flexor and abductor muscle strength measured using a hand-held dynamometer in individuals with chronic kidney disease (CKD). Secondary objectives include assessing the association between lower limb muscle strength measured with a hand-held dynamometer and handgrip strength, physical activity level, frailty, gait speed, performance in the 10-repetition sit-to-stand-to-sit test, ultrasound assessment of the rectus femoris muscle, and health-related quality of life.

Первичные конечные точки

• Reference values for Lower Limb Strengh [Срок оценки: Baseline]

Вторичные конечные точки (11)

• Muscle strength assessment Handgrip [Срок оценки: Baseline]
• Human Activity Profile [Срок оценки: Baseline]
• Screening Sarcopenia risk [Срок оценки: Baseline]
• Frailty assessment using the "Fatigue, Resistance, Ambulation, Illnesses,Loss of Weight" (FRAIL) questionnaire [Срок оценки: Baseline]
• Frailty assessment using the Fried Frailty Phenotype [Срок оценки: Baseline]
• 4-metre gait speed assessment [Срок оценки: Baseline]
• Health-related quality of life (HRQoL) [Срок оценки: Baseline]
• Sit-to-Stand-to-Sit tests- 10 repetitions (STS-10) and Sit-to-Stand-to-Sit tests 60 seconds (STS-60) [Срок оценки: Baseline]
• Assessment of muscle thickness [Срок оценки: Baseline]
• Assessment of muscle cross-sectional area [Срок оценки: Baseline]
• Assessment of muscle subcutaneous fat thickness [Срок оценки: Baseline]

Критерии участия

Критерии включения

• ≥1 months on HD (3 weekly sessions of 4 hours)

Критерии исключения

• Lower-limb amputation;
• Neurological, musculoskeletal or osteoarticular disorders;
• Severe/unstable comorbidities (e.g., decompensated heart failure or diabetes, unstable angina, recent MI, uncontrolled hypertension, severe lung disease, acute infection);
• <1 months on HD;
• <2 sessions/week,
• Inability to understand assessments.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Diaverum Madrid — Madrid

Публикации

• Sabatino A, Regolisti G, Delsante M, Di Motta T, Cantarelli C, Pioli S, Grassi G, Batini V, Gregorini M, Fiaccadori E. Noninvasive evaluation of muscle mass by ultrasonography of quadriceps femoris muscle in End-Stage Renal Disease patients on hemodialysis. Clin Nutr. 2019 Jun;38(3):1232-1239. doi: 10.1016/j.clnu.2018.05.004. Epub 2018 May 19. PMID 29866494
• Johansen KL, Painter P, Kent-Braun JA, Ng AV, Carey S, Da Silva M, Chertow GM. Validation of questionnaires to estimate physical activity and functioning in end-stage renal disease. Kidney Int. 2001 Mar;59(3):1121-7. doi: 10.1046/j.1523-1755.2001.0590031121.x. PMID 11231369
• Segura-Orti E, Junque-Jimenez A, Dubuis V, Reboredo MM, Benavent-Caballer V, Valtuena-Gimeno N, Barros FS, Silva DT, Martinez-Olmos FJ. Handheld Dynamometry Testing During Dialysis: Intrarater and Interrater Reliability Study. J Ren Nutr. 2025 May;35(3):433-442. doi: 10.1053/j.jrn.2025.01.002. Epub 2025 Jan 24. PMID 39864471
• Junque Jimenez A, Esteve Simo V, Andreu Periz L, Segura Orti E. The Relationship between Physical Activity Levels and Functional Capacity in Patients with Advanced Chronic Kidney Disease. Clin Nurs Res. 2021 Mar;30(3):360-368. doi: 10.1177/1054773820907757. Epub 2020 Feb 19. PMID 32075428
• Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23. PMID 28114792

Идентификаторы

NCT: NCT07642778 · CEEI26/84

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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