This Study Aims to Measure the Effect of Acute Hospitalisation on the Physical and Cognitive Functioning of Older Orthopaedic Patients (Aged 65 or Above).

Recruiting

• Conditions: Deconditioning; Orthopedic Fractures; Hospital Associated Deconditioning; Orthopaedic Injuries

• Registration Number: NCT06932224
• Lead Sponsor: University of Southampton

Brief Summary

This study aims to investigate the impact of hospitalisation on physical and cognitive performance in patients aged 65 and older admitted with an orthopaedic injury. This will be achieved by asking patients to participate in a series of physical and cognitive performance questionnaires and tests. These questionnaires and tests will be performed by the patients as close to their admission as possible and then again at day 7 of hospitalisation (or discharge if earlier) and at 4-6 weeks after discharge. However, if a patient's hospital stay lasts more than 30 days, they will be asked to take part in the interim data collection timepoint.

To summarize, patients will be assessed at least 3 times, 4 if your hospital stay is longer than 30 days. The first and second assessments will be in the hospital, and the third will be 4-6 weeks after discharge at you home (or where is appropriate). Additionally, patients will be asked to wear an activity watch between the first and second assessment.

The study will also explore patients experiences of their hospital stay and opinions on deconditioning, including the views and opinions of hospital staff. This information will be gathered by having interviews with a sample of the patients who took part in the questionnaires and tests and by having interviews with hospital staff. The interview will be conducted by the main researcher, Thomas Cartledge, and will take place either over the phone, online or in-person, depending on your preference. The interviews will be audio and/or video recorded, however the recordings will be deleted immediately once transcription is completed. The duration of the interview will last approximately 30-60 mins.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-27
• Status Verified: 2024-12
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-17
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-12-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sarcopenia risk assessed via the SARC-F questionnaire.	From enrolment to the last data collection point at 4-6 weeks post discharge.	Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire.; Using a scale ranging from 0 to 10, with a higher score indicating a higher sarcopenia risk.
Functional mobility measured via the Short Physical Performance Battery (SPPB) questionnaire.	4-6 weeks (discharge to the final data collection point).	The SPPB score ranges from 0 to 12 points, with a higher score indicating better functional mobility.
Health-related quality of life measured by the EQ-5D questionnaire.	From enrolment to the last data collection point at 4-6 weeks post discharge.	The EuroQol-5D (EQ-5D) is a two part questionnaire. The first part is a descriptive system using five dimensions to describe health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).; The second part is a visual analogue scale (VAS) where participants indicate their overall health by drawing a line on a scale from 100 (best imaginable health) to 0 (worst imaginable health).
Physical function measured via the Barthel Index questionnaire.	From enrolment to the last data collection point at 4-6 weeks post discharge.	The original Barthel Index will be used, which uses a score ranging from 0 to 100. A higher score indicates a better physical function.
Cognitive impairment measured via The Montreal Cognitive Assessment (MoCA) score.	From enrolment to the last data collection point at 4-6 weeks post discharge.	The MoCA score ranges from 0 to 30. A score of 26 or higher is generally considered normal, with lower scores indicating potential cognitive impairment.
Delirium measured via the 4AT score.	From enrolment to the last data collection point at 4-6 weeks post discharge.	The 4AT test is scored from 0-12. A score of 0 suggests no delirium and no moderate-severe cognitive impairment. A score from 1-3 suggests cognitive impairment but not delirium. A score of 4 or more suggest delirium.
Muscle strength measured via a hand held dynamometer.	From enrolment to the last data collection point at 4-6 weeks post discharge
Muscle mass measured via Bioelectrical Impedance Analysis.	From enrolment to the last data collection point at 4-6 weeks post discharge.	The specific measure used will be fat free mass (FFM)

Secondary Outcome Measures

Name	Time	Method
Hospital re-admission rate	6 months	Will see if patients are readmitted to hospital within 6 months. Information abstracted from medical records.

Trial Locations

Locations (1)

University Hospitals Southampton Foundation Trust; 🇬🇧 Southampton, Hampshire, United Kingdom