SarcopeniaSARCO-COXNCT07734129
Sarcopenia Screening in Advanced Coxarthrosis: The SARCO-COX Study
A study testing Intensive Physical Rehabilitation and Preoperative Sarcopenia Screening in people with Sarcopenia and Coxarthrosis, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Coxarthrosis
- What is being tested?
- Intensive Physical Rehabilitation and Preoperative Sarcopenia Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
FIMABIS
Málaga, 29007
FIMABIS, +34 951030435, investigacion.independiente@ibima.eu
Pablo Casado Adam, Doctor
About this study
Official title: Efficacy of a Sarcopenia Screening Program in Subjects With Advanced Coxarthrosis. SARCO-COX Randomized Intervention 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.
Read more
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.
- Conditions
- Sarcopenia, Coxarthrosis
- Being tested
- Intensive Physical Rehabilitation, Preoperative Sarcopenia Screening
- Keywords
- Muscle strength, Biomarkers, Exercise therapy, Sarcopenia, Hip arthrosis
- Medical subject headings
- Sarcopenia, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Physical RehabilitationBehavioural
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 ScreeningDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Patients with Sarcopenia who perform physical training | Experimental | Patients with preoperative SAR who will undergo an intervention intensive post-surgical group physical therapy, starting 6 months after surgery. Receives: Behavioral: Intensive Physical Rehabilitation; Diagnostic Test: Preoperative Sarcopenia Screening |
| Group 2 - Patients with Sarcopenia who do not perform physical training. | Experimental | Patients with preoperative SAR who will be treated with standard postoperative therapy. Receives: Diagnostic Test: Preoperative Sarcopenia Screening |
| Group 3 - Control patients. | No intervention | Subjects in the same age range and sex without preoperative SAR will be recruited and will be treated with standard post-surgical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Grip Strength
Upper body isometric muscle strength assessed using a calibrated handgrip dynamometer following a standardized protocol.
Measured: 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).
Measured: Baseline (3 months pre-surgery), 6 months, 12 months, 18 months, and 24 months post-surgery.
Secondary outcomes (23)
Gait Speed
Time taken to walk a 4-meter course at normal pace.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6, 12, 18, and 24 months post-surgery.
Lower Extremity Muscle Strength
Isometric muscle strength of the lower limbs measured using dynamometry.
Measured: 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.
Measured: Baseline, 6, 12, 18, and 24 months post-surgery.
Rectus Femoris Anteroposterior Diameter
Anteroposterior diameter of the rectus femoris muscle assessed by ultrasound.
Measured: Baseline, 6, 12, 18, and 24 months post-surgery.
Rectus Femoris Mediolateral Diameter
Mediolateral diameter of the rectus femoris muscle assessed by ultrasound.
Measured: 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.
Measured: 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.
Measured: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Myostatin Concentration
Quantification of circulating myostatin concentration using ELISA.
Measured: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Irisin Concentration
Quantification of circulating irisin concentration using ELISA.
Measured: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Follistatin Concentration
Quantification of circulating follistatin concentration using ELISA.
Measured: 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.
Measured: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Creatine Kinase (CK) Level
Concentration of circulating creatine kinase enzyme.
Measured: 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.
Measured: Visit 2 (Surgery Day).
Vastus Lateralis Satellite Cell Density
Quantification of satellite cells per muscle fiber counted in intraoperative vastus lateralis biopsy sections.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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"
Measured: 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).
Measured: 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).
Measured: Baseline, 6, 12, 18, and 24 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734129
- Sponsor's protocol ID
- SICEIA-2025-002775
- Acronym
- SARCO-COX
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Sarcopenia Screening Program in Subjects With Advanced Coxarthrosis. SARCO-COX Randomized Intervention Study
- ClinicalTrials.gov ID
- NCT07734129
- Acronym / sponsor ID
- SARCO-COX / SICEIA-2025-002775
- Conditions
- Sarcopenia, Coxarthrosis
- Keywords
- Muscle strength, Biomarkers, Exercise therapy, Sarcopenia, Hip arthrosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Patients with Sarcopenia who perform physical training | Experimental | Behavioral: Intensive Physical Rehabilitation, Diagnostic Test: Preoperative Sarcopenia ScreeningPatients with preoperative SAR who will undergo an intervention intensive post-surgical group physical therapy, starting 6 months after surgery. |
| Group 2 - Patients with Sarcopenia who do not perform physical training. | Experimental | Diagnostic Test: Preoperative Sarcopenia ScreeningPatients with preoperative SAR who will be treated with standard postoperative therapy. |
| Group 3 - Control patients. | No intervention | –Subjects in the same age range and sex without preoperative SAR will be recruited and will be treated with standard post-surgical therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Physical RehabilitationParticipants 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. | Behavioural | Group 1 - Patients with Sarcopenia who perform physical training |
| Preoperative Sarcopenia ScreeningParticipants 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. | Diagnostic test | Group 1 - Patients with Sarcopenia who perform physical training, Group 2 - Patients with Sarcopenia who do not perform physical training. |
Primary outcome
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.
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).
23 secondary outcomes
Gait Speed
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Timed Up and Go (TUG) Test Duration
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
6-Minute Walk Test Distance
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
5-Repetition Chair Stand Test Time
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Lower Extremity Muscle Strength
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Rectus Femoris Muscle Thickness
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Rectus Femoris Anteroposterior Diameter
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Rectus Femoris Mediolateral Diameter
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Serum Interleukin-6 (IL-6) Concentration
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Tumor Necrosis Factor-Alpha (TNFa) Concentration
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Myostatin Concentration
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Irisin Concentration
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Follistatin Concentration
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
High-Sensitivity C-Reactive Protein (hs-CRP) Level
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Serum Creatine Kinase (CK) Level
Time frame: Baseline, Surgery Day (Visit 2), 6, 12, 18, and 24 months post-surgery.
Vastus Lateralis Fiber Cross-Sectional Area
Time frame: Visit 2 (Surgery Day).
Vastus Lateralis Satellite Cell Density
Time frame: Visit 2 (Surgery Day).
Tissue Myokine Immunohistochemical Expression Score
Time frame: Visit 2 (Surgery Day).
Short Physical Performance Battery (SPPB) Total Score
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Oxford Hip Score (OHS)
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Visual Analog Scale (VAS) Pain Score
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
EQ-5D Health Visual Analog Scale Score
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
SARC-F Screening Questionnaire Total Score
Time frame: Baseline, 6, 12, 18, and 24 months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Physical Rehabilitation and Preoperative Sarcopenia Screening in people with Sarcopenia and Coxarthrosis, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FIMABIS (+34 951030435, investigacion.independiente@ibima.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Grip Strength (time frame: Baseline (3 months pre-surgery), 6 months, 12 months, 18 months, and 24 months post-surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.