Coxarthrosis, Sarcopenia
Conditions
Keywords
Muscle strength, Biomarkers, Exercise therapy, Sarcopenia, Hip arthrosis
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.
Interventions
BEHAVIORALIntensive Physical Rehabilitation
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.
DIAGNOSTIC_TESTPreoperative Sarcopenia Screening
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.
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
This is a single-center, randomized, open-label, parallel-group interventional study with a concurrent control group conducted at Hospital Regional Universitario de Málaga. The study will enroll patients aged ≥65 years with advanced hip arthrosis scheduled for elective total hip arthroplasty to evaluate the effectiveness of an intensive postoperative rehabilitation program and to investigate the biological profiles associated with sarcopenia over a 2-year follow-up period. Participants with preoperative sarcopenia will be randomized to either (1) an intensive supervised postoperative rehabilitation program or (2) standard postoperative care. Participants without sarcopenia will receive standard postoperative care and will serve as a non-randomized control group. Study assessments will be performed at three visits: approximately 3 months before surgery (baseline), 6 months after surgery, and 12 months after surgery. Clinical, functional, imaging, biochemical, and muscle biopsy dat
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Manual Grip Strength | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed | Baseline, 6, 12, 18, and 24 months post-surgery. | Time taken to walk a 4-meter course at normal pace. |
| Timed Up and Go (TUG) Test Duration | 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. |
| 6-Minute Walk Test Distance | Baseline, 6, 12, 18, and 24 months post-surgery. | Total distance walked in 6 minutes to evaluate functional aerobic performance. |
| 5-Repetition Chair Stand Test Time | 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. |
| Lower Extremity Muscle Strength | Baseline, 6, 12, 18, and 24 months post-surgery. | Isometric muscle strength of the lower limbs measured using dynamometry. |
| Rectus Femoris Muscle Thickness | 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. |
| Rectus Femoris Anteroposterior Diameter | Baseline, 6, 12, 18, and 24 months post-surgery. | Anteroposterior diameter of the rectus femoris muscle assessed by ultrasound. |
| Rectus Femoris Mediolateral Diameter | Baseline, 6, 12, 18, and 24 months post-surgery. | Mediolateral diameter of the rectus femoris muscle assessed by ultrasound. |
| Serum Interleukin-6 (IL-6) Concentration | 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. |
| Serum Tumor Necrosis Factor-Alpha (TNFa) Concentration | Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery. | Quantification of circulating TNFa concentration using ELISA. |
| Serum Myostatin Concentration | Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery. | Quantification of circulating myostatin concentration using ELISA. |
| Serum Irisin Concentration | Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery. | Quantification of circulating irisin concentration using ELISA. |
| Serum Follistatin Concentration | Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery. | Quantification of circulating follistatin concentration using ELISA. |
| High-Sensitivity C-Reactive Protein (hs-CRP) Level | Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery. | Concentration of serum hs-CRP to assess systemic low-grade inflammation. |
| Serum Creatine Kinase (CK) Level | Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery. | Concentration of circulating creatine kinase enzyme. |
| Vastus Lateralis Fiber Cross-Sectional Area | 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. |
| Vastus Lateralis Satellite Cell Density | Visit 2 (Surgery Day). | Quantification of satellite cells per muscle fiber counted in intraoperative vastus lateralis biopsy sections. |
| Tissue Myokine Immunohistochemical Expression Score | 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. |
| Short Physical Performance Battery (SPPB) Total Score | 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). |
| Oxford Hip Score (OHS) | 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). |
| Visual Analog Scale (VAS) Pain Score | 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" |
| EQ-5D Health Visual Analog Scale Score | 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). |
| SARC-F Screening Questionnaire Total Score | 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). |
Countries
Spain
Contacts
CONTACTFIMABIS
Outcome results
None listed