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

11 de junho de 2026 atualizado por: Eva Segura Ortí, Cardenal Herrera University

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.

Visão geral do estudo

Status

Recrutamento

Condições

Doença Renal Crônica em Hemodiálise

Tipo de estudo

Observacional

Inscrição (Estimado)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Eva Ms Segura Ortí, Professor
Número de telefone: +34671580094
E-mail: esegura@uchceu.es

Locais de estudo

Espanha
- - Madrid, Espanha
    - Recrutamento
    - Diaverum Madrid
    - Contato:
      
      Eva Ms Segura Ortí, Professor
      
      Número de telefone: +34671580094
      
      E-mail: esegura@uchceu.es
    - Contato:
      
      Shaira Ms Martínez Vaquera, Manager
      
      Número de telefone: +34 683 236 547
      
      E-mail: shaira.martinez@diaverum.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Reference values for Lower Limb Strengh Prazo: Baseline	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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Muscle strength assessment Handgrip Prazo: Baseline	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 Prazo: Baseline	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 Prazo: Baseline	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 Prazo: Baseline	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 Prazo: Baseline	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 Prazo: Baseline	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) Prazo: Baseline	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) Prazo: Baseline	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 Prazo: Baseline	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 Prazo: Baseline	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 Prazo: Baseline	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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cardenal Herrera University

Colaboradores

Medizinisches Versorgungszentrum Diaverum Potsdam

Investigadores

Cadeira de estudo: Eva Ms Segura Ortí, Professor, Cardenal Herrera University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ