DeconditioningNCT06932224
This Study Aims to Measure the Effect of Acute Hospitalisation on the Physical and Cognitive Functioning of Older Orthopaedic Patients (Aged 65 or Above).
An observational study of Deconditioning and Orthopedic Fractures, run by University of Southampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Deconditioning, Orthopedic Fractures, Hospital Associated Deconditioning
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Nov 2024to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
- Work at SGH
- Work with older orthopaedic inpatients
- Be able to provide written consent
Who cannot join
- 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:
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Southampton Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength measured via a hand held dynamometer.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrolment to the last data collection point at 4-6 weeks post discharge.
Secondary outcomes (2)
Hospital re-admission rate
Will see if patients are readmitted to hospital within 3 months. Information abstracted from medical records.
Measured: 3 months
Hospital re-admission rate
Will see if patients are readmitted to hospital within 6 months. Information abstracted from medical records.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start27 Nov 2024
- Primary completion31 Jan 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932224
- Sponsor's protocol ID
- RHM MED2068
- Status last verified
- May 2026
- First submitted
- 26 Mar 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-associated Deconditioning: Exploring Factors Contributing to the Physical and Cognitive Decline of Older Adults During Hospitalisation
- ClinicalTrials.gov ID
- NCT06932224
- Acronym / sponsor ID
- RHM MED2068
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
- Work at SGH
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle strength measured via a hand held dynamometer.
Time frame: 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)
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.
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.
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).
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.
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.
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.
2 secondary outcomes
Hospital re-admission rate
Time frame: 3 months
Hospital re-admission rate
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deconditioning and Orthopedic Fractures, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength measured via a hand held dynamometer. (time frame: From enrolment to the last data collection point at 4-6 weeks post discharge). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.