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Recruiting NCT07642778

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

— Observational Chronic Kidney Disease on Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease on Hemodialysis. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Reference values for Lower Limb Strengh [Time frame: Baseline]
Secondary outcome measures (11)
  • Muscle strength assessment Handgrip [Time frame: Baseline]
  • Human Activity Profile [Time frame: Baseline]
  • Screening Sarcopenia risk [Time frame: Baseline]
  • Frailty assessment using the "Fatigue, Resistance, Ambulation, Illnesses,Loss of Weight" (FRAIL) questionnaire [Time frame: Baseline]
  • Frailty assessment using the Fried Frailty Phenotype [Time frame: Baseline]
  • 4-metre gait speed assessment [Time frame: Baseline]
  • Health-related quality of life (HRQoL) [Time frame: Baseline]
  • Sit-to-Stand-to-Sit tests- 10 repetitions (STS-10) and Sit-to-Stand-to-Sit tests 60 seconds (STS-60) [Time frame: Baseline]
  • Assessment of muscle thickness [Time frame: Baseline]
  • Assessment of muscle cross-sectional area [Time frame: Baseline]
  • Assessment of muscle subcutaneous fat thickness [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Diaverum Madrid — Madrid

Publications

  • 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

Identifiers

NCT: NCT07642778 · CEEI26/84

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗