About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Intensive Physical Rehabilitation
BehavioralParticipants 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.
Preoperative Sarcopenia Screening
Diagnostic testParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Manual Grip Strength
Upper body isometric muscle strength assessed using a calibrated handgrip dynamometer following a standardized protocol.
Skeletal Muscle Mass Index (SMI)
Ratio of appendicular skeletal muscle mass to height squared, estimated via bioelectrical impedance analysis (BIA).
Secondary outcomes
Gait Speed
Time taken to walk a 4-meter course at normal pace.
Timed Up and Go (TUG) Test Duration
Time taken for a participant to rise from a chair, walk 3 meters, turn around, walk back, and sit down.
6-Minute Walk Test Distance
Total distance walked in 6 minutes to evaluate functional aerobic performance.
5-Repetition Chair Stand Test Time
Time taken to complete 5 consecutive sit-to-stand repetitions from a chair without using arms.
Sponsors and contacts
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