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NCT07734129

Overview

NCT ID: NCT07734129
Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludOTHER
Official Title: Efficacy of a Sarcopenia Screening Program in Subjects With Advanced Coxarthrosis. SARCO-COX Randomized Intervention Study
Brief Summary: 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.

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Central Contacts: FIMABISContact
investigacion.independiente@ibima.eu+34 951030435

Participant Group/Arms

Group 1 - Patients with Sarcopenia who perform physical trainingExperimental

Patients with preoperative SAR who will undergo an intervention intensive post-surgical group physical therapy, starting 6 months after surgery.

Behavioral: Intensive Physical Rehabilitation

Diagnostic Test: Preoperative Sarcopenia Screening

Group 2 - Patients with Sarcopenia who do not perform physical training.Experimental

Patients with preoperative SAR who will be treated with standard postoperative therapy.

Diagnostic Test: Preoperative Sarcopenia Screening

Group 3 - Control patients.No Intervention

Subjects in the same age range and sex without preoperative SAR will be recruited and will be treated with standard post-surgical therapy.