Understanding Acute Sarcopenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

Official Title
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Understanding Acute Sarcopenia: a Time-limited Cohort Study to Characterise Changes in Muscle Mass and Physical Function in Older Adults Following Hospitalisation

Conditions
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Sarcopenia

Intervention / Treatment
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* Procedure: Colorectal surgery procedure
* Procedure: Emergency abdominal surgery
* Drug: Antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ELECTIVE COHORT Aged 70 years or older at time of recruitment Expected to undergo an elective major colorectal surgery procedure EMERGENCY SURGERY COHORT Aged 70 years or older at time of recruitment Emergency admission Expected to undergo emergency abdominal procedure during admission, or emergency abdominal procedure performed within previous 48 hours MEDICAL COHORT Aged 70 years or older at time of recruitment Emergency admission for acute bacterial infection or presumed acute bacterial infection Exclusion Criteria: ELECTIVE COHORT Unable to provide written informed consent at time of recruitment Unable to understand verbal English Life expectancy less than 30 days EMERGENCY SURGERY COHORT Unable to provide written informed consent at time of recruitment and no consultee available Unable to understand verbal English Life expectancy less than 30 days MEDICAL COHORT Unable to provide written informed consent at time of recruitment and no consultee available Unable to understand verbal English Life expectancy less than 30 days

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elective colorectal surgery<br>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. | Procedure: Colorectal surgery procedure<br>* Elective admission for colorectal surgery<br>|
| Experimental: Emergency abdominal surgery<br>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. | Procedure: Emergency abdominal surgery<br>* Emergency admission necessitating emergency surgery<br>|
| Experimental: Medical patients<br>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 | Drug: Antibiotics<br>* Treatment for infection and reason for admission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute sarcopenia, muscle, physical function, older adults