Understanding Acute Sarcopenia

Not Applicable

• Conditions: Sarcopenia
• Interventions: Procedure: Colorectal surgery procedure; Procedure: Emergency abdominal surgery; Drug: Antibiotics

• Registration Number: NCT03858192
• Lead Sponsor: University of Birmingham

Brief Summary

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

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?

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Study Start: 2019-05-03
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21
• Primary Completion: 2021-07
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elective colorectal surgery	Colorectal surgery procedure	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.
Emergency abdominal surgery	Emergency abdominal surgery	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	Antibiotics	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

Primary Outcome Measures

Name	Time	Method
Physical function	Three months	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.

Secondary Outcome Measures

Name	Time	Method
Short Physical Performance Battery (SPPB)	Three months	Change in Short Physical Performance Battery (SPPB) score at (elective cohort)
Bilateral Anterior Thigh Thickness (BATT)	Three months	Change in BATT (elective and emergency cohorts)
Acceptability (patient-reported)	Three months	Total derived acceptability score as measured by questionnaire upon study completion (elective and emergency cohorts)
Handgrip strength	Three months	Change in handgrip strength (elective and emergency cohorts)
Acute changes during hospitalisation - gait speed	One week	Change in gait speed within one week of hospitalisation (elective and emergency cohorts)
Acute changes during hospitalisation - BATT	One week	Change in BATT within one week of hospitalisation (elective and emergency cohorts)
Acute changes during hospitalisation - handgrip strength	One week	Change in handgrip strength within one week of hospitalisation (elective and emergency cohorts)
Rectus femoris echogenicity (quantified using ImageJ software)	Immediately postoperatively, one week postoperatively, and at three months	Change in rectus femoris echogenicity (elective and emergency cohorts)
BATT: subcutaneous tissue ratio (BATT-SCR)	Immediately postoperatively and one week postoperatively	Change in BATT: subcutaneous tissue ratio (BATT-SCR) (elective and emergency cohorts)
Acute sarcopenia	One week postoperatively	Incidence of acute sarcopenia (elective and emergency cohorts)
Physical activity - steps taken	One month	Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)
Physical activity - distance walked	One month	Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)
Sedentary time	One month	Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)
Acceptability (objective) - refusal	Three months	Participant refusal rates (elective and emergency cohorts)
Acceptability (objective) - missing data	Three months	Missing data (elective and emergency cohorts)
Acceptability (objective) - drop-outs	Three months	Drop-out rates (elective and emergency cohorts)

Trial Locations

Locations (1)

Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom