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

NCT06932224 | Active Not Recruiting

• 1 other identifier: RHM MED2068
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Deconditioning; Orthopedic Fractures; Hospital Associated Deconditioning; Orthopaedic Injuries

Keywords

Hospital acquired deconditioning; Hospital associated deconditioning; Physical functioning; Cognitive functioning; Orthopaedic; Older patient; Older adults (65 years and older); Muscle strength; Muscle mass

Outcome Measures

Primary Outcomes (8)

• 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.

  The specific measure used will be fat free mass (FFM)

  From enrolment to the last data collection point at 4-6 weeks post discharge.

• Sarcopenia risk assessed via the SARC-F questionnaire.

  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.

  From enrolment to the last data collection point at 4-6 weeks post discharge.

• Functional mobility measured via the Short Physical Performance Battery (SPPB) questionnaire.

  The SPPB score ranges from 0 to 12 points, with a higher score indicating better functional mobility.

  4-6 weeks (discharge to the final data collection point).

• Health-related quality of life measured by the EQ-5D questionnaire.

  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).

  From enrolment to the last data collection point at 4-6 weeks post discharge.

• Physical function measured via the Barthel Index questionnaire.

  The original Barthel Index will be used, which uses a score ranging from 0 to 100. A higher score indicates a better physical function.

  From enrolment to the last data collection point at 4-6 weeks post discharge.

• Cognitive impairment measured via The Montreal Cognitive Assessment (MoCA) score.

  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.

  From enrolment to the last data collection point at 4-6 weeks post discharge.

• Delirium measured via the 4AT score.

  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.

  From enrolment to the last data collection point at 4-6 weeks post discharge.

Secondary Outcomes (2)

• Hospital re-admission rate

  3 months

• Hospital re-admission rate

  6 months

Other Outcomes (3)

• Perceptions and attitudes towards hospital-associated deconditioning measured via semi-structured interviews.

  Time frame for patients will be their last hospital admission (approx 7 days long) and staff will be asked to recall information from their last 2 months of work.

• Exploring practical ways of preventing hospital-associated deconditioning via semi-structed interviews.

  Time frame for patients will be their last hospital admission (approx 7 days long) and staff will be asked to recall information from their last 2 months of work.

• Exploring barriers and facilitators to physical and cognitive risk factors of hospital-associated deconditioning via semi-structed interviews.

  Time frame for patients will be their last hospital admission (approx 7 days long) and staff will be asked to recall information from their last 2 months of work.

Study Arms (2)

Older patients with orthopaedic conditions/injuries

This cohort will take part in the physical and cognitive questionnaires and tests at all 3 (4 if interim is needed) time points. 20 patients of this cohort will take part in one semi-structured interview.

Southampton General Hospital Staff

10 hospital staff to take part in one semi-structured interview.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults admitted to SGH with an acute orthopaedic condition/injury. Hospital staff who work at SGH who work with older orthopaedic inpatients.

You may qualify if:

• Older adults aged 65 years or older
• Able to provide written consent
• Admitted to Southampton General Hospital (SGH) for an acute orthopaedic condition
• Been admitted to SGH \<72 hours before recruitment

You may not qualify if:

• Older adults who are not able to safely complete the quantitative measurement tools, as advised by the patient's clinician
• Patients receiving end of life care
• Require a hoist to transfer from bed to chair prior to hospitalisation
• Been admitted to SGH \>72 hours before recruitment
• Unable to consent
• Hospital staff criteria:
• Work at SGH
• Work with older orthopaedic inpatients
• Be able to provide written consent

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

University Hospitals Southampton Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 17, 2025
• Study Start: November 27, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

GB (1)