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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03858192
Enrollment
168
Registered
2019-02-28
Start date
2019-05-03
Completion date
2021-09-30
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

Acute sarcopenia, muscle, physical function, older adults

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?

Interventions

PROCEDUREColorectal surgery procedure

Elective admission for colorectal surgery

Emergency admission necessitating emergency surgery

DRUGAntibiotics

Treatment for infection and reason for admission

Sponsors

Dowager Countess Eleanor Peel Trust
CollaboratorUNKNOWN
University Hospital Birmingham NHS Foundation Trust
CollaboratorOTHER
MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research
CollaboratorUNKNOWN
University of Birmingham
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Prospective cohort study

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physical functionThree monthsChange 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

MeasureTime frameDescription
Bilateral Anterior Thigh Thickness (BATT)Three monthsChange in BATT (elective and emergency cohorts)
Handgrip strengthThree monthsChange in handgrip strength (elective and emergency cohorts)
Acute changes during hospitalisation - gait speedOne weekChange in gait speed within one week of hospitalisation (elective and emergency cohorts)
Acute changes during hospitalisation - BATTOne weekChange in BATT within one week of hospitalisation (elective and emergency cohorts)
Acute changes during hospitalisation - handgrip strengthOne weekChange 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 monthsChange in rectus femoris echogenicity (elective and emergency cohorts)
BATT: subcutaneous tissue ratio (BATT-SCR)Immediately postoperatively and one week postoperativelyChange in BATT: subcutaneous tissue ratio (BATT-SCR) (elective and emergency cohorts)
Short Physical Performance Battery (SPPB)Three monthsChange in Short Physical Performance Battery (SPPB) score at (elective cohort)
Physical activity - steps takenOne weekPostoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)
Physical activity - distance walkedOne weekPostoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)
Sedentary timeOne weekPostoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)
Acceptability (objective) - refusalThree monthsParticipant refusal rates (elective and emergency cohorts)
Acceptability (objective) - missing dataThree monthsMissing data (elective and emergency cohorts)
Acceptability (objective) - drop-outsThree monthsDrop-out rates (elective and emergency cohorts)
Acceptability (patient-reported)Three monthsTotal derived acceptability score as measured by questionnaire upon study completion (elective and emergency cohorts)
Acute sarcopeniaOne week postoperativelyIncidence of acute sarcopenia (elective and emergency cohorts)

Countries

United Kingdom

Contacts

Primary ContactCarly Welch, MBChB
c.welch@bham.ac.uk+44 (0)121 414 3344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026