Understanding Acute Sarcopenia

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

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 Overview

• Status: Unknown
• Conditions: Sarcopenia
• Intervention / Treatment: Procedure: Colorectal surgery procedure; Procedure: Emergency abdominal surgery; Drug: Antibiotics

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 Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B152GW
      • Recruiting
      • Queen Elizabeth Hospital Birmingham
      • Contact: Carly Welch; Email: c.welch@bham.ac.uk
      • Contact: Thomas Jackson; Email: t.jackson@bham.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Elective colorectal surgery; 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; Elective admission for colorectal surgery
EXPERIMENTAL: 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.	Procedure: Emergency abdominal surgery; Emergency admission necessitating emergency surgery
EXPERIMENTAL: Medical patients; 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; Treatment for infection and reason for admission

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: University Hospital Birmingham NHS Foundation Trust; Dowager Countess Eleanor Peel Trust; MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research
• Investigators: Study Director: Carly Welch, MBChB, University of Birmingham; Principal Investigator: Thomas Jackson, MBChB, PhD, University of Birmingham

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Overall project website (to be updated throughout course of study)

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2019
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (ACTUAL): February 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Acute sarcopenia, muscle, physical function, older adults
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: RG_18-213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No