An interventional study of Intensive Physical Rehabilitation and Preoperative Sarcopenia Screening in Sarcopenia and Coxarthrosis, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Not yet recruiting at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Screening
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:
The study aims to determine whether early identification and targeted rehabilitation of sarcopenia can improve functional outcomes and quality of life after hip replacement.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients with preoperative SAR who will be treated with standard postoperative therapy.
Diagnostic Test: Preoperative Sarcopenia Screening
Subjects in the same age range and sex without preoperative SAR will be recruited and will be treated with standard post-surgical therapy.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud