Understanding Acute Sarcopenia

University of Birmingham

Status: Unknown

Conditions: Sarcopenia

Treatments: Drug: Antibiotics; Procedure: Emergency abdominal surgery; Procedure: Colorectal surgery procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03858192

RG_18-213

Details and patient eligibility

About

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.

Full 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?

Enrollment: 168 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 3 patient groups

Elective colorectal surgery

Experimental group

Description:

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.

Treatment:

Procedure: Colorectal surgery procedure

Emergency abdominal surgery

Experimental group

Description:

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.

Treatment:

Procedure: Emergency abdominal surgery

Medical patients

Experimental group

Description:

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

Treatment:

Drug: Antibiotics