Sarcopenia Screening in Advanced Coxarthrosis: The SARCO-COX Study

NCT07734129 | Not Yet Recruiting

• 1 other identifier: SICEIA-2025-002775
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Coxarthrosis

Keywords

Muscle strength; Biomarkers; Exercise therapy; Sarcopenia; Hip arthrosis

Outcome Measures

Primary Outcomes (2)

• Manual Grip Strength

  Upper body isometric muscle strength assessed using a calibrated handgrip dynamometer following a standardized protocol.

  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).

  Baseline (3 months pre-surgery), 6 months, 12 months, 18 months, and 24 months post-surgery.

Secondary Outcomes (23)

• Gait Speed

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

• Timed Up and Go (TUG) Test Duration

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

• 6-Minute Walk Test Distance

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

• 5-Repetition Chair Stand Test Time

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

• Lower Extremity Muscle Strength

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

Study Arms (3)

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.

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.

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.

Interventions

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.

Group 1 - Patients with Sarcopenia who perform physical training

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.

Group 1 - Patients with Sarcopenia who perform physical training; Group 2 - Patients with Sarcopenia who do not perform physical training.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

FIMABIS

Málaga, 29007, Spain

Location

MeSH Terms

Conditions

Sarcopenia; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

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

Central Study Contacts

FIMABIS

CONTACT

+34 951030435; investigacion.independiente@ibima.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)