Role of Nutritional Status in Functional Recovery of Older Adults Undergoing Virtual Reality-augmented Shoulder Rehabilitation (VIR)

NCT07282561 | Recruiting

• 2 other identifiers: 37.25_CET2_CBM_VIRPNC0000007 - "Fit4MedRob"
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Malnutrition is a clinical syndrome defined by involuntary weight loss and/or a persistent imbalance between nutritional needs and intake, leading to functional decline. Its prevalence is particularly high among older adults-affecting about 17% of community-dwelling elders, 30% of those in rehabilitation settings, and between 20% and 60% of individuals in acute care environments. Malnutrition is therefore a common yet often underrecognized factor influencing health outcomes in geriatric populations. Osteoarthritis (OA), a degenerative joint disease marked by the deterioration of articular cartilage, results in pain and reduced mobility. It affects approximately 9.6% of men and 18% of women over the age of 60. With global life expectancy rising and populations aging, OA is projected to become the fourth leading cause of disability by 2025. Joint replacement surgery provides significant relief for severe cases, and consequently, an increasing number of adults-averaging around 70 years of age-undergo elective joint replacement surgeries followed by rehabilitation for degenerative OA. In this context, Virtual Reality (VR) technology is emerging as an innovative tool in rehabilitation. VR can create engaging, interactive environments that promote motor relearning by allowing clinicians to adjust practice intensity and provide real-time feedback. This adaptability enables personalized rehabilitation programs designed to enhance patient motivation and adherence. Preliminary studies have shown encouraging results, suggesting that VR-assisted therapy may improve motor recovery and functional outcomes, and its use in rehabilitation settings is rapidly expanding. Previous research has identified a strong link between malnutrition and sarcopenia (loss of muscle mass) and reduced physical performance. However, findings remain inconsistent regarding how nutritional status influences functional recovery in elderly individuals undergoing rehabilitation. While some studies indicate a positive relationship between good nutrition and improved recovery, others suggest that nutritional status affects baseline functional capacity more than the rate or degree of functional improvement during rehabilitation. It is also important to recognize that most available studies have focused on patients admitted for rehabilitation after hip fractures or stroke, conditions often associated with sudden functional decline. To date, only one known study has investigated elderly patients undergoing rehabilitation following hip or knee replacement surgery due to degenerative osteoarthritis. Interestingly, that study found a statistically significant positive association between nutritional status and functional recovery specifically in this subgroup-an association not observed among patients recovering from hip fractures or stroke. Nonetheless, the study had limitations: nutritional status was measured using only the Mini Nutritional Assessment-Short Form (MNA-SF), and evaluation occurred post-surgery, without preoperative or long-term follow-up data. Moreover, there are no available data on rehabilitation outcomes for shoulder osteoarthritis, an increasingly common condition among older adults that significantly impacts autonomy in daily living. Given these gaps, the current research aims to determine whether malnutrition modifies the effects of VR-enhanced shoulder rehabilitation after elective surgery on functional recovery-that is, the ability to perform activities of daily living (ADLs)-in frail elderly patients. The hypothesis is that poor nutritional status could reduce the benefits of intensive, technology-based rehabilitation, while adequate nutrition may enhance neuroplasticity, muscle strength, and overall recovery potential. This investigation seeks to clarify three main aspects:

1. 1.The prevalence and severity of malnutrition among elderly individuals undergoing elective surgery and subsequent VR-based rehabilitation.
2. 2.The interaction between nutritional status and functional outcomes, examining whether malnutrition acts as an effect modifier or mediator in recovery trajectories.
3. 3.The specific contribution of VR technology in improving rehabilitation adherence, motivation, and overall functional independence compared to conventional therapy.

Conditions

Shoulder Arthroplasty; Rehabilitation; Virtual Reality; Malnutrition Elderly

Outcome Measures

Primary Outcomes (1)

• Malnutrition as effect modifier of the impact of shoulder rehabiliation

  "Absolute functional gain" (AFG), defined as the difference between the modified Barthel Index at the end of rehabilitation minus the modified Barthel Index before the rehabilitation (i.e. after surgery).

  From enrollment to the end of rehabilitation treatment at 4 weeks

Study Arms (2)

Virtual reality-augmented shoulder rehabilitation

ACTIVE COMPARATOR

Device: Oculus Quest

Usual care

NO INTERVENTION

Interventions

Oculus Quest DEVICE

Virtual reality device to simulate specific exercises aimed at rehabilitating patients with musculoskeletal shoulder pathologies.

Virtual reality-augmented shoulder rehabilitation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Claudio Pedone: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Rome, 00128, Italy

RECRUITING

Central Study Contacts

Claudio Pedone, Prof.

CONTACT

+39 06 22 541 1349; c.pedone@policlinicocampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 15, 2025
• Study Start: November 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-11

Locations

IT (1)