Efficacy of a Sarcopenia Screening Program in Subjects With Advanced Coxarthrosis. SARCO-COX Randomized Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Manual Grip Strength
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 1 - Patients with Sarcopenia who perform physical training
Patients with preoperative SAR who will undergo an intervention intensive post-surgical group physical therapy, starting 6 months after surgery.
干预措施: Intensive Physical Rehabilitation (Behavioral)
Group 1 - Patients with Sarcopenia who perform physical training
Patients with preoperative SAR who will undergo an intervention intensive post-surgical group physical therapy, starting 6 months after surgery.
干预措施: Preoperative Sarcopenia Screening (Diagnostic Test)
Group 2 - Patients with Sarcopenia who do not perform physical training.
Patients with preoperative SAR who will be treated with standard postoperative therapy.
干预措施: Preoperative Sarcopenia Screening (Diagnostic Test)
Group 3 - Control patients.
Subjects in the same age range and sex without preoperative SAR will be recruited and will be treated with standard post-surgical therapy.
结局指标
主要结局
Manual Grip Strength
时间窗: Baseline (3 months pre-surgery), 6 months, 12 months, 18 months, and 24 months post-surgery.
Upper body isometric muscle strength assessed using a calibrated handgrip dynamometer following a standardized protocol.
Skeletal Muscle Mass Index (SMI)
时间窗: Baseline (3 months pre-surgery), 6 months, 12 months, 18 months, and 24 months post-surgery.
Ratio of appendicular skeletal muscle mass to height squared, estimated via bioelectrical impedance analysis (BIA).
次要结局
- Gait Speed(Baseline, 6, 12, 18, and 24 months post-surgery.)
- Timed Up and Go (TUG) Test Duration(Baseline, 6, 12, 18, and 24 months post-surgery.)
- 6-Minute Walk Test Distance(Baseline, 6, 12, 18, and 24 months post-surgery.)
- 5-Repetition Chair Stand Test Time(Baseline, 6, 12, 18, and 24 months post-surgery.)
- Lower Extremity Muscle Strength(Baseline, 6, 12, 18, and 24 months post-surgery.)
- Rectus Femoris Muscle Thickness(Baseline, 6, 12, 18, and 24 months post-surgery.)
- Rectus Femoris Anteroposterior Diameter(Baseline, 6, 12, 18, and 24 months post-surgery.)
- Rectus Femoris Mediolateral Diameter(Baseline, 6, 12, 18, and 24 months post-surgery.)
- Serum Interleukin-6 (IL-6) Concentration(Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.)
- Serum Tumor Necrosis Factor-Alpha (TNFa) Concentration(Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.)
- Serum Myostatin Concentration(Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.)
- Serum Irisin Concentration(Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.)
- Serum Follistatin Concentration(Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.)
- High-Sensitivity C-Reactive Protein (hs-CRP) Level(Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.)
- Serum Creatine Kinase (CK) Level(Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.)
- Vastus Lateralis Fiber Cross-Sectional Area(Visit 2 (Surgery Day).)
- Vastus Lateralis Satellite Cell Density(Visit 2 (Surgery Day).)
- Tissue Myokine Immunohistochemical Expression Score(Visit 2 (Surgery Day).)
- Short Physical Performance Battery (SPPB) Total Score(Baseline, 6, 12, 18, and 24 months post-surgery.)
- Oxford Hip Score (OHS)(Baseline, 6, 12, 18, and 24 months post-surgery.)
- Visual Analog Scale (VAS) Pain Score(Baseline, 6, 12, 18, and 24 months post-surgery.)
- EQ-5D Health Visual Analog Scale Score(Baseline, 6, 12, 18, and 24 months post-surgery.)
- SARC-F Screening Questionnaire Total Score(Baseline, 6, 12, 18, and 24 months post-surgery.)