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

NCT07642778 | Recruiting

• 1 other identifier: CEEI26/84
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease on Hemodialysis

Keywords

Chronic Kidney Disease; Lower limb strength; Intradialytic assessment

Outcome Measures

Primary Outcomes (1)

• Reference values for Lower Limb Strengh

  Lower limb strengh will be evaluated using handheld dynamometer (Lafayette Manual Muscle Testing System Model-01165, Lafayette IN, USA) for hip flexors and hip abductors.Testing will follow a strict structured order: first hip flexors and then hip abductors. Within each muscle group, legs will be alternated, starting with the dominant leg and then the nondominant leg, to allow specific rest periods between muscle groups (15 seconds). Hip flexors will be assessed with the patients with both hips and knees bent. The dynamometer will be placed on the anterior part of the thigh, 2 centimetres below of patella. Hip abductors will be assessed with both legs extended at the hip and knee. The dynamometer will be placed on the lateral part of the thigh, 2 centimetres below of the knee joint line. During both measurements physiotherapist will apply force in the opposite direction of the movement. Unit of measure: Newton (N).

  Baseline

Secondary Outcomes (11)

• Muscle strength assessment Handgrip

  Baseline

• Human Activity Profile

  Baseline

• Screening Sarcopenia risk

  Baseline

• Frailty assessment using the "Fatigue, Resistance, Ambulation, Illnesses,Loss of Weight" (FRAIL) questionnaire

  Baseline

• Frailty assessment using the Fried Frailty Phenotype

  Baseline

Study Arms (1)

REHAB-CKD group

The target population of the present study consists of patients with chronic kidney disease undergoing hemodialysis in DIAVERUM centers in Spain.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with CKD undergoing HD in DIAVERUM centers in Spain, male and female, aged 18 and older, who have been on dialysis for more than one month.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead
• Medizinisches Versorgungszentrum Diaverum Potsdam: collaborator

Study Sites (1)

Diaverum Madrid

Madrid, Spain

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Eva Ms Segura Ortí, Professor

  Cardenal Herrera University

  STUDY CHAIR

Central Study Contacts

Eva Ms Segura Ortí, Professor

CONTACT

+34671580094; esegura@uchceu.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

ES (1)