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NCT Number: NCT06932224

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Deconditioning Hospital Associated Deconditioning Orthopaedic Injuries Orthopedic Fractures

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Southampton Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient criteria:

Inclusion:

  • 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

Exclusion:

  • 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:

Inclusion:

  • Work at SGH
  • Work with older orthopaedic inpatients
  • Be able to provide written consent

Treatment and study plan

Primary outcomes

  1. Muscle strength measured via a hand held dynamometer.

    Time frame: From enrolment to the last data collection point at 4-6 weeks post discharge

  2. Muscle mass measured via Bioelectrical Impedance Analysis.

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

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

  3. Sarcopenia risk assessed via the SARC-F questionnaire.

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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).

  6. Physical function measured via the Barthel Index questionnaire.

    Time frame: 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.

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

    Time frame: 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.

  8. Delirium measured via the 4AT score.

    Time frame: 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.

Secondary outcomes

  1. Hospital re-admission rate

    Time frame: 3 months

    Will see if patients are readmitted to hospital within 3 months. Information abstracted from medical records.

  2. Hospital re-admission rate

    Time frame: 6 months

    Will see if patients are readmitted to hospital within 6 months. Information abstracted from medical records.

Other outcomes

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

    Time frame: 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.

    Interviews will be conducted with older orthopaedic patients and hospital staff.

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

    Time frame: 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.

    Interviews will be conducted with older orthopaedic patients and hospital staff.

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

    Time frame: 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.

    Interviews will be conducted with older orthopaedic patients and hospital staff.

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Registry information

Official study title

Hospital-associated Deconditioning: Exploring Factors Contributing to the Physical and Cognitive Decline of Older Adults During Hospitalisation

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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