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| Name | Class |
|---|---|
| Dowager Countess Eleanor Peel Trust | UNKNOWN |
| University Hospital Birmingham NHS Foundation Trust | OTHER |
| MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research | UNKNOWN |
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This study aims to characterise acute changes in muscle mass, strength, physical performance in hospitalised older adults. We will assess the impact of these changes upon physical function at three month follow-up, and assess for the impact of clinical and immune-endocrine factors upon these changes.
Study Design
Time-limited cohort study involving serial measurements of Bilateral Anterior Thigh Thickness (BATT) using ultrasound, handgrip strength, physical performance, and physical function measured using the Patient Reported Outcome Measures Information System (PROMIS®). We aim to fully characterise changes in these patients, and will perform a comprehensive evaluation of clinical factors including nutrition and physical activity, and measure immune-endocrine markers of inflammation.
Study Participants
Elective colorectal surgery, emergency abdominal surgery, and medical patients aged 70 years and older
Planned Size of recruitment target
56 elective colorectal patients, 56 emergency abdominal surgery patients, and 56 medical patients with acute infections
Follow up duration
3 months
Primary research question
Does acute change in quadriceps muscle thickness, handgrip strength and/or physical performance within one week of hospitalisation predict change in patient reported physical function at three months?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elective colorectal surgery | Experimental | Patients who are expected to undergo a major colorectal surgery procedure will be recruited to this study preoperatively and followed-up until three months postoperatively. |
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| Emergency abdominal surgery | Experimental | Patients who are admitted as an emergency and undergo abdominal surgery will be recruited from general surgery wards either preoperatively or within 48 hours of surgery. They will be followed-up until three month postoperatively. |
|
| Medical patients | Experimental | Patients admitted under general medicine with an infection will be recruited from general medicine wards within 48 hours of admission. They will be followed-up until three month post-admission |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorectal surgery procedure | Procedure | Elective admission for colorectal surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical function | Change in physical function at three months as measured by the T score derived from the Patient Reported Outcome Measures Information System (PROMIS®) - Item Bank v. 2.0, Physical Function, Short Form 10b. This is a patient-reported outcome measure of physical function. Raw scores are collected out of a maximum of 50; minimum of 10. These are converted to T scores, which are used for analysis (mean 50, SD 10; range 13.8 - 61.3). Higher scores are representative of better physical function. | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery (SPPB) | Change in Short Physical Performance Battery (SPPB) score at (elective cohort) | Three months |
| Bilateral Anterior Thigh Thickness (BATT) | Change in BATT (elective and emergency cohorts) |
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Inclusion Criteria:
ELECTIVE COHORT
EMERGENCY SURGERY COHORT
MEDICAL COHORT
Exclusion Criteria:
ELECTIVE COHORT
EMERGENCY SURGERY COHORT
MEDICAL COHORT
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carly Welch, MBChB | Contact | +44 (0)121 414 3344 | c.welch@bham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Carly Welch, MBChB | University of Birmingham | Study Director |
| Thomas Jackson, MBChB, PhD | University of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital Birmingham | Recruiting | Birmingham | West Midlands | B152GW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29392090 | Background | Welch C, K Hassan-Smith Z, A Greig C, M Lord J, A Jackson T. Acute Sarcopenia Secondary to Hospitalisation - An Emerging Condition Affecting Older Adults. Aging Dis. 2018 Feb 1;9(1):151-164. doi: 10.14336/AD.2017.0315. eCollection 2018 Feb. | |
| 30642375 | Background | Welch C, Greig CA, Hassan-Smith ZK, Pinkney TD, Lord JM, Jackson TA. A pilot observational study measuring acute sarcopenia in older colorectal surgery patients. BMC Res Notes. 2019 Jan 14;12(1):24. doi: 10.1186/s13104-019-4049-y. |
| Label | URL |
|---|---|
| Overall project website (to be updated throughout course of study) | View source |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Prospective cohort study
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| Emergency abdominal surgery | Procedure | Emergency admission necessitating emergency surgery |
|
| Antibiotics | Drug | Treatment for infection and reason for admission |
|
| Three months |
| Handgrip strength | Change in handgrip strength (elective and emergency cohorts) | Three months |
| Acute changes during hospitalisation - gait speed | Change in gait speed within one week of hospitalisation (elective and emergency cohorts) | One week |
| Acute changes during hospitalisation - BATT | Change in BATT within one week of hospitalisation (elective and emergency cohorts) | One week |
| Acute changes during hospitalisation - handgrip strength | Change in handgrip strength within one week of hospitalisation (elective and emergency cohorts) | One week |
| Rectus femoris echogenicity (quantified using ImageJ software) | Change in rectus femoris echogenicity (elective and emergency cohorts) | Immediately postoperatively, one week postoperatively, and at three months |
| BATT: subcutaneous tissue ratio (BATT-SCR) | Change in BATT: subcutaneous tissue ratio (BATT-SCR) (elective and emergency cohorts) | Immediately postoperatively and one week postoperatively |
| Acute sarcopenia | Incidence of acute sarcopenia (elective and emergency cohorts) | One week postoperatively |
| Physical activity - steps taken | Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts) | One week |
| Physical activity - steps taken | Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts) | One month |
| Physical activity - distance walked | Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts) | One week |
| Physical activity - distance walked | Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts) | One month |
| Sedentary time | Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts) | One week |
| Sedentary time | Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts) | One month |
| Acceptability (objective) - refusal | Participant refusal rates (elective and emergency cohorts) | Three months |
| Acceptability (objective) - missing data | Missing data (elective and emergency cohorts) | Three months |
| Acceptability (objective) - drop-outs | Drop-out rates (elective and emergency cohorts) | Three months |
| Acceptability (patient-reported) | Total derived acceptability score as measured by questionnaire upon study completion (elective and emergency cohorts) | Three months |
| 33632138 | Derived | Welch C, Greig C, Masud T, Jackson TA. Muscle quantity and function measurements are acceptable to older adults during and post- hospitalisation: results of a questionnaire-based study. BMC Geriatr. 2021 Feb 25;21(1):141. doi: 10.1186/s12877-021-02091-3. |
| 32650734 | Derived | Welch C, Greig CA, Masud T, Pinkney T, Jackson TA. Protocol for understanding acute sarcopenia: a cohort study to characterise changes in muscle quantity and physical function in older adults following hospitalisation. BMC Geriatr. 2020 Jul 10;20(1):239. doi: 10.1186/s12877-020-01626-4. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |