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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
150
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.
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.
FIMABIS
Málaga, Spain
Manual Grip Strength
Upper body isometric muscle strength assessed using a calibrated handgrip dynamometer following a standardized protocol.
Time frame: Baseline (3 months pre-surgery), 6 months, 12 months, 18 months, and 24 months post-surgery.
Skeletal Muscle Mass Index (SMI)
Ratio of appendicular skeletal muscle mass to height squared, estimated via bioelectrical impedance analysis (BIA).
Time frame: Baseline (3 months pre-surgery), 6 months, 12 months, 18 months, and 24 months post-surgery.
Gait Speed
Time taken to walk a 4-meter course at normal pace.
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
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.
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
6-Minute Walk Test Distance
Total distance walked in 6 minutes to evaluate functional aerobic performance.
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
5-Repetition Chair Stand Test Time
Time taken to complete 5 consecutive sit-to-stand repetitions from a chair without using arms.
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Lower Extremity Muscle Strength
Isometric muscle strength of the lower limbs measured using dynamometry.
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Rectus Femoris Muscle Thickness
Muscle thickness measured at the mid-1/3 level of the rectus femoris muscle using B-mode ultrasound with a linear probe.
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Rectus Femoris Anteroposterior Diameter
Anteroposterior diameter of the rectus femoris muscle assessed by ultrasound.
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Rectus Femoris Mediolateral Diameter
Mediolateral diameter of the rectus femoris muscle assessed by ultrasound.
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Serum Interleukin-6 (IL-6) Concentration
Quantification of circulating IL-6 concentration from fasting blood samples using ELISA.
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Tumor Necrosis Factor-Alpha (TNFa) Concentration
Quantification of circulating TNFa concentration using ELISA.
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Myostatin Concentration
Quantification of circulating myostatin concentration using ELISA.
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Irisin Concentration
Quantification of circulating irisin concentration using ELISA.
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Follistatin Concentration
Quantification of circulating follistatin concentration using ELISA.
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
High-Sensitivity C-Reactive Protein (hs-CRP) Level
Concentration of serum hs-CRP to assess systemic low-grade inflammation.
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Creatine Kinase (CK) Level
Concentration of circulating creatine kinase enzyme.
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Vastus Lateralis Fiber Cross-Sectional Area
Mean cross-sectional area of muscle fibers assessed in formalin-fixed paraffin-embedded intraoperative biopsies using Hematoxylin-Eosin (H\&E) staining and morphometric analysis.
Time frame: Visit 2 (Surgery Day).
Vastus Lateralis Satellite Cell Density
Quantification of satellite cells per muscle fiber counted in intraoperative vastus lateralis biopsy sections.
Time frame: Visit 2 (Surgery Day).
Tissue Myokine Immunohistochemical Expression Score
Percentage of positive area for IL-6, myostatin, irisin, and follistatin in intraoperative samples of vastus lateralis muscle and peripheral fat assessed by immunohistochemistry.
Time frame: Visit 2 (Surgery Day).
Short Physical Performance Battery (SPPB) Total Score
Composite physical performance score evaluated through balance tests, gait speed, and chair stands. Total score ranges from 0 (worst) to 12 (best).
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Oxford Hip Score (OHS)
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).
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Visual Analog Scale (VAS) Pain Score
Self-reported pain intensity on a numeric scale where 0 represents "no pain" and 10 represents "worst imaginable pain"
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
EQ-5D Health Visual Analog Scale Score
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).
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
SARC-F Screening Questionnaire Total Score
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).
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
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