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

May 5, 2026 updated by: University of Southampton

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospitals Southampton Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength measured via a hand held dynamometer.
Time Frame: From enrolment to the last data collection point at 4-6 weeks post discharge
From enrolment to the last data collection point at 4-6 weeks post discharge
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)
From enrolment to the last data collection point at 4-6 weeks post discharge.
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.
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.
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.
4-6 weeks (discharge to the final data collection point).
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).
From enrolment to the last data collection point at 4-6 weeks post discharge.
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.
From enrolment to the last data collection point at 4-6 weeks post discharge.
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.
From enrolment to the last data collection point at 4-6 weeks post discharge.
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.
From enrolment to the last data collection point at 4-6 weeks post discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital re-admission rate
Time Frame: 3 months
Will see if patients are readmitted to hospital within 3 months. Information abstracted from medical records.
3 months
Hospital re-admission rate
Time Frame: 6 months
Will see if patients are readmitted to hospital within 6 months. Information abstracted from medical records.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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: 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.
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: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2024

Primary Completion (Actual)

January 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RHM MED2068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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