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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease on Hemodialysis

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Eva Ms Segura Ortí, Professor; Phone Number: +34671580094; Email: esegura@uchceu.es

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Diaverum Madrid
    • Contact: Eva Ms Segura Ortí, Professor; Phone Number: +34671580094; Email: esegura@uchceu.es
    • Contact: Shaira Ms Martínez Vaquera, Manager; Phone Number: +34 683 236 547; Email: shaira.martinez@diaverum.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
REHAB-CKD group; The target population of the present study consists of patients with chronic kidney disease undergoing hemodialysis in DIAVERUM centers in Spain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength assessment Handgrip	It will use a Jamar® Approved Hydraulic Hand Dynamometer. The participant will be seated in a chair with their back straight and the arm flexed at 90°. The test will be repeated three times for each hand (3-5 seconds), with rest periods between repetitions to avoid muscle fatigue. Unit of measure: Kilogram (Kg). The cut-off points for loss of muscle strength will be set greater than or equal to 27 kg for men and greater than or equal to 16 kg for women, based on values defined by Mathiowetz et al. and included in the European clinical nutrition guidelines as a phenotypic criterion for disease-related malnutrition.	Baseline
Human Activity Profile	The Human Activity Profile (HAP) consist of 94 questions addressing different domains of daily activity and participation, with three possible answers for each item: 'still doing,' 'stopped doing,' or 'never did.' For each item, the participant will have to choose one of these responses. Based on each answer, two scores will be calculated: the Maximal Activity Score (MAS), which corresponds to the activity with the highest effort demand that the volunteer 'still performs'; and the Adjusted Activity Score (AAS), which will be calculated by subtracting the number of items the subject 'has stopped doing' below the MAS value from the MAS itself. The AAS will provide the value of activity that the subject has ceased to perform compared to what they were doing before. Unit of Measure: Absolute number.	Baseline
Screening Sarcopenia risk	Screening for Sarcopenia risk will be performed using the "Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls" (SARC-F) questionnaire, which consists of five self-reported questions based on the subjects' perception of their limitations regarding strength, walking ability, rising from a chair, climbing stairs, and their history and number of falls. Each item will be scored from 0 to 2, where 0 = no difficulty, 1 = some difficulty, and 2 = great difficulty, or if the subject uses devices or cannot perform the task without personal assistance. The total SARC-F score can range from 0 to 10, and subjects with a score ≥ 4 points will be considered at risk of sarcopenia, in accordance with the recommendations of the European consensus on sarcopenia. Unit of Measure: Absolute number.	Baseline
Frailty assessment using the "Fatigue, Resistance, Ambulation, Illnesses,Loss of Weight" (FRAIL) questionnaire	Frailty will be assessed using the five questions (fatigue, climbing stairs, walking 100 m, comorbidity, and weight loss) that comprise the "Fatigue, Resistance, Ambulation, Illnesses,Loss of Weight" (FRAIL) questionnaire. A score of 1 or higher suggests frailty. Unit of Measure: Absolute Number	Baseline
Frailty assessment using the Fried Frailty Phenotype	Frailty will be assessed using the five components (weight loss, handgrip weakness, fatigue, low physical activity, and gait speed) of the Fried Frailty Phenotype. A score of 1 or higher suggests frailty. Unit of Measure: Absolute number	Baseline
4-metre gait speed assessment	The 4-metre gait speed test will be performed preferably before the second HD session of the week, in a corridor of the unit. Patients will be asked to walk between two marks at their usual pace, using walking aids if necessary. A practice trial will be provided, and the times of two trials will be recorded in seconds and converted to m/s. The best of the two trials will be used for analysis. Unit of Measure: Absolute number	Baseline
Health-related quality of life (HRQoL)	Health-related quality of life (HRQoL) will be assessed using the Spanish version of the Medical Outcomes Study Short Form-36 (SF-36) questionnaire . Scores range from 0 to 100, with higher scores indicating better HRQoL. Results are reported across eight subscales (physical functioning, vitality, role physical, general health, social functioning, mental health, role emotional, and bodily pain) and two summary components (physical and mental components). Unit of Measure: Absolute number	Baseline
Sit-to-Stand-to-Sit tests- 10 repetitions (STS-10) and Sit-to-Stand-to-Sit tests 60 seconds (STS-60)	The Sit-to-Stand-to-Sit- 10 (STS-10) and Sit-to-Stand-to-Sit-60 (STS-60) tests will be performed preferably before the second or third HD session. Participants will be seated in a chair with their arms crossed over the chest, feet on the floor, and back supported against the backrest whenever possible. The chair must be stable and placed against a wall to minimize the risk of falls. Participants will be asked to keep their arms crossed to avoid using them for assistance and, with their feet on the ground, to stand up and sit down 10 consecutive times as quickly as possible. The time required to complete the test will be recorded in seconds. After a rest period following the STS-10, the same procedure will be performed for the STS-60, in which the number of repetitions completed in 60 seconds will be recorded. Both the number of repetitions and the Rating of Perceived Exertion (RPE) will be documented. Unit of measure: absolute number	Baseline
Assessment of muscle thickness	Muscle quantity and quality will be evaluated using ultrasound measurement of the cross-sectional area of the rectus femoris muscle, performed 30 minutes after the start of HD, on a different day from the muscle strength assessments. The assessment will be conducted on the dominant lower limb, with the participant in the supine position, the limb fully extended, and the muscles relaxed. It will be measured muscle thickness, (unit of measure: millimeter).	Baseline
Assessment of muscle cross-sectional area	Muscle quantity and quality will be evaluated using ultrasound measurement of the cross-sectional area of the rectus femoris muscle, performed 30 minutes after the start of HD, on a different day from the muscle strength assessments. The assessment will be conducted on the dominant lower limb, with the participant in the supine position, the limb fully extended, and the muscles relaxed. It will be measured muscle cross-sectional area ( unit of measure: millimeter squared).	Baseline
Assessment of muscle subcutaneous fat thickness	Muscle quantity and quality will be evaluated using ultrasound measurement of the cross-sectional area of the rectus femoris muscle, performed 30 minutes after the start of HD, on a different day from the muscle strength assessments. The assessment will be conducted on the dominant lower limb, with the participant in the supine position, the limb fully extended, and the muscles relaxed. It will be measured muscle subcutaneous fat thickness, (unit of measure: millimeter).	Baseline

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Collaborators: Medizinisches Versorgungszentrum Diaverum Potsdam
• Investigators: Study Chair: Eva Ms Segura Ortí, Professor, Cardenal Herrera University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Lower limb strength; Intradialytic assessment
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: CEEI26/84

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No