Does nutrition affect recovery after shoulder replacement with virtual reality–enhanced rehab?
Role of Nutritional Status in Functional Recovery of Older Adults Undergoing Virtual Reality-augmented Shoulder Rehabilitation (VIR)
This project will test whether better nutritional status helps adults 60 and older recover function faster after elective shoulder surgery when they use virtual reality–assisted rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico Academic / other |
| Locations | 1 site (Rome, Rome) |
| Trial ID | NCT07282561 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults aged 60 and older with frailty who are scheduled for elective shoulder surgery and provides virtual reality–augmented shoulder rehabilitation using an Oculus Quest device. Researchers will record participants' baseline nutritional status and follow functional recovery during and after a standardized VR rehabilitation program. The design links objective nutritional measures with rehabilitation outcomes to see if malnutrition predicts poorer recovery or modifies the effect of VR therapy. Standard exclusions include active cancer, severe organ failure, cognitive impairment, inability to feed orally, and recent COVID-19 infection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older with frailty who have an indication for elective shoulder surgery, can eat orally, can engage in rehabilitation, and can provide informed consent.
Not a fit: People with active cancer, recent shoulder fractures, severe cognitive impairment (MMSE <18), advanced heart/lung/renal failure, malabsorptive disease, or inability to participate in rehab or oral feeding are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could lead to routine nutrition screening and targeted interventions that improve and speed functional recovery after shoulder surgery in older, frail patients.
How similar studies have performed: Prior studies have shown that VR-assisted rehabilitation can improve shoulder function and adherence and that poor nutritional status worsens surgical recovery, but combining nutrition-focused analysis with VR rehab is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals aged 60 years old or older; * Frailty defined according to the Clinical Frailty Scale (Cesari et al., 2018); * Diagnosis of shoulder diseases with indication to elective surgery; Exclusion Criteria: * Diagnosis of rheumatic diseases; * Shoulder fracture; * Actual SARS-CoV-2 infection; * Diagnosis of active cancer; * Any contraindication to oral feeding; * Malabsorptive diseases; * Cognitive impairment (MMSE\<18); * Severe chronic diseases (heart failure NYHA III-IV, lung failure, renal failure); * Any contraindication to rehabilitation; * Rehabilitation duration ≤ 14 days; * Inability to provide an informed consent;
Where this trial is running
Rome, Rome
- Fondazione Policlinico Universitario Campus Bio-Medico — Rome, Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Claudio Pedone, Prof.
- Email: c.pedone@policlinicocampus.it
- Phone: +39 06 22 541 1349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.