Sarcopenia Screening in Advanced Coxarthrosis: The SARCO-COX Study

Официальное название

Efficacy of a Sarcopenia Screening Program in Subjects With Advanced Coxarthrosis. SARCO-COX Randomized Intervention Study

Обзор

The SARCO-COX study evaluates whether screening for sarcopenia (loss of muscle strength and mass) in adults aged 65 years or older with advanced hip osteoarthritis, followed by a structured postoperative exercise program, improves recovery after total hip replacement surgery compared with standard care. Participants will undergo assessments of muscle strength, muscle mass, physical function, pain, and quality of life before surgery and during follow-up. Blood samples and a small muscle biopsy obtained during the planned surgery will be analyzed to study biomarkers related to muscle health. A total of 150 people are expected to participate in this study. Participants will be divided into three groups: * Group 1: People with sarcopenia who will take part in an exercise programme following surgery. * Group 2: People with sarcopenia who will receive the usual care and follow-up after their surgery. * Group 3: people without sarcopenia who are undergoing surgery and will receive the usual care and follow-up. The study aims to determine whether early identification and targeted rehabilitation of sarcopenia can improve functional outcomes and quality of life after hip replacement.

Вмешательства

• Поведенческое Intensive Physical Rehabilitation
  Participants with sarcopenia assigned to the intervention group will undergo a supervised group physical rehabilitation program starting 6 months after total hip arthroplasty. The program consists of 1-hour sessions conducted twice weekly for 2 months and includes warm-up stretching exercises (10 minutes), 30 minutes of aerobic cycling, 15 minutes of upper and lower limb strengthening exercises, and a 5-minute cool-down with stretching and relaxation.
• Диагностический тест Preoperative Sarcopenia Screening
  Participants will undergo preoperative screening for sarcopenia using the SARC-F questionnaire, handgrip strength measured by dynamometry, gait speed, and skeletal muscle index assessed by bioelectrical impedance analysis to identify sarcopenia before elective total hip arthroplasty.

Первичные конечные точки

• Manual Grip Strength [Срок оценки: Baseline (3 months pre-surgery), 6 months, 12 months, 18 months, and 24 months post-surgery.]
• Skeletal Muscle Mass Index (SMI) [Срок оценки: Baseline (3 months pre-surgery), 6 months, 12 months, 18 months, and 24 months post-surgery.]

Вторичные конечные точки (12)

• Gait Speed [Срок оценки: Baseline, 6, 12, 18, and 24 months post-surgery.]
• Timed Up and Go (TUG) Test Duration [Срок оценки: Baseline, 6, 12, 18, and 24 months post-surgery.]
• 6-Minute Walk Test Distance [Срок оценки: Baseline, 6, 12, 18, and 24 months post-surgery.]
• 5-Repetition Chair Stand Test Time [Срок оценки: Baseline, 6, 12, 18, and 24 months post-surgery.]
• Lower Extremity Muscle Strength [Срок оценки: Baseline, 6, 12, 18, and 24 months post-surgery.]
• Rectus Femoris Muscle Thickness [Срок оценки: Baseline, 6, 12, 18, and 24 months post-surgery.]
• Rectus Femoris Anteroposterior Diameter [Срок оценки: Baseline, 6, 12, 18, and 24 months post-surgery.]
• Rectus Femoris Mediolateral Diameter [Срок оценки: Baseline, 6, 12, 18, and 24 months post-surgery.]
• Serum Interleukin-6 (IL-6) Concentration [Срок оценки: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.]
• Serum Tumor Necrosis Factor-Alpha (TNFa) Concentration [Срок оценки: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.]
• Serum Myostatin Concentration [Срок оценки: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.]
• Serum Irisin Concentration [Срок оценки: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.]

Критерии участия

Критерии включения

• Subjects age >= 65 years of age
• Previous diagnosis of advanced hip osteoarthritis.
• Patients who are on the surgical waiting list for total joint replacement hip.
• Barthel Index > 80 points.
• That they will undergo surgery at the Regional University Hospital of Malaga.

Критерии исключения

• Patients who refuse to accept and sign the informed consent form surgical intervention.
• Patients who refuse to accept and sign the informed consent form participation in the study.
• Subjects diagnosed with immunodeficiency or undergoing immunosuppressive treatment.
• Subjects diagnosed with inflammatory or hematological disease.
• Subjects with coagulation disorders.
• Subjects with lung disease, heart disease or unstable high blood pressure.
• Subjects diagnosed with neurodegenerative disease that prevents them from performing physical exercise.
• Subjects with psychiatric pathology that prevents the performance of physical exercise and adherence to treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Испания · 1 центр

• FIMABIS — Málaga

Идентификаторы

NCT: NCT07734129 · SICEIA-2025-002775

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗