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NCT Number: NCT07734129

Sarcopenia Screening in Advanced Coxarthrosis: The SARCO-COX Study

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.

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Key information

Conditions

Sarcopenia Arthritis Atrophy Coxarthrosis Joint Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Osteoarthritis Osteoarthritis, Hip Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive Physical Rehabilitation

Behavioral

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.

Preoperative Sarcopenia Screening

Diagnostic Test

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.

Primary outcomes

  1. Manual Grip Strength

    Time frame: 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.

  2. Skeletal Muscle Mass Index (SMI)

    Time frame: 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).

Secondary outcomes

  1. Gait Speed

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Time taken to walk a 4-meter course at normal pace.

  2. Timed Up and Go (TUG) Test Duration

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Time taken for a participant to rise from a chair, walk 3 meters, turn around, walk back, and sit down.

  3. 6-Minute Walk Test Distance

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Total distance walked in 6 minutes to evaluate functional aerobic performance.

  4. 5-Repetition Chair Stand Test Time

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Time taken to complete 5 consecutive sit-to-stand repetitions from a chair without using arms.

  5. Lower Extremity Muscle Strength

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Isometric muscle strength of the lower limbs measured using dynamometry.

  6. Rectus Femoris Muscle Thickness

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Muscle thickness measured at the mid-1/3 level of the rectus femoris muscle using B-mode ultrasound with a linear probe.

  7. Rectus Femoris Anteroposterior Diameter

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Anteroposterior diameter of the rectus femoris muscle assessed by ultrasound.

  8. Rectus Femoris Mediolateral Diameter

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Mediolateral diameter of the rectus femoris muscle assessed by ultrasound.

  9. Serum Interleukin-6 (IL-6) Concentration

    Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.

    Quantification of circulating IL-6 concentration from fasting blood samples using ELISA.

  10. Serum Tumor Necrosis Factor-Alpha (TNFa) Concentration

    Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.

    Quantification of circulating TNFa concentration using ELISA.

  11. Serum Myostatin Concentration

    Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.

    Quantification of circulating myostatin concentration using ELISA.

  12. Serum Irisin Concentration

    Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.

    Quantification of circulating irisin concentration using ELISA.

  13. Serum Follistatin Concentration

    Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.

    Quantification of circulating follistatin concentration using ELISA.

  14. High-Sensitivity C-Reactive Protein (hs-CRP) Level

    Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.

    Concentration of serum hs-CRP to assess systemic low-grade inflammation.

  15. Serum Creatine Kinase (CK) Level

    Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.

    Concentration of circulating creatine kinase enzyme.

  16. Vastus Lateralis Fiber Cross-Sectional Area

    Time frame: Visit 2 (Surgery Day).

    Mean cross-sectional area of muscle fibers assessed in formalin-fixed paraffin-embedded intraoperative biopsies using Hematoxylin-Eosin (H&E) staining and morphometric analysis.

  17. Vastus Lateralis Satellite Cell Density

    Time frame: Visit 2 (Surgery Day).

    Quantification of satellite cells per muscle fiber counted in intraoperative vastus lateralis biopsy sections.

  18. Tissue Myokine Immunohistochemical Expression Score

    Time frame: Visit 2 (Surgery Day).

    Percentage of positive area for IL-6, myostatin, irisin, and follistatin in intraoperative samples of vastus lateralis muscle and peripheral fat assessed by immunohistochemistry.

  19. Short Physical Performance Battery (SPPB) Total Score

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Composite physical performance score evaluated through balance tests, gait speed, and chair stands. Total score ranges from 0 (worst) to 12 (best).

  20. Oxford Hip Score (OHS)

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Joint-specific 12-item questionnaire assessing pain and functional capacity in hip osteoarthritis. Total score ranges from 0 (severe osteoarthritis) to 48 (satisfactory joint function).

  21. Visual Analog Scale (VAS) Pain Score

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Self-reported pain intensity on a numeric scale where 0 represents "no pain" and 10 represents "worst imaginable pain"

  22. EQ-5D Health Visual Analog Scale Score

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Self-rated overall health status measured on a vertical thermometer visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

  23. SARC-F Screening Questionnaire Total Score

    Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.

    Self-reported 5-item questionnaire assessing strength, walking assistance, rising from a chair, stair climbing, and falls. Total score ranges from 0 to 10 (scores $\\ge 4$ indicate risk of sarcopenia).

Study contacts

Contact information is provided by the study sponsor or research team.

FIMABIS

CONTACT

[email protected]

+34 951030435

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Other

Registry information

Official study title

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

Acronym: SARCO-COX

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 29, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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