Clinical trial NCT03858192: Understanding Acute Sarcopenia
Official title: Understanding Acute Sarcopenia: a Time-limited Cohort Study to Characterise Changes in Muscle Mass and Physical Function in Older Adults Following Hospitalisation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: Acute sarcopenia, muscle, physical function, older adults
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Dowager Countess Eleanor Peel Trust
name: University Hospital Birmingham NHS Foundation Trust
name: MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research
First posted: 2019-02-28
Enrollment: 168
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cohort study
Primary purpose: DIAGNOSTIC

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?

Eligibility criteria: 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

Primary outcomes:
measure: Physical function
timeFrame: Three months
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Three months
measure: Bilateral Anterior Thigh Thickness (BATT)
timeFrame: Three months
measure: Handgrip strength
timeFrame: Three months
measure: Acute changes during hospitalisation - gait speed
timeFrame: One week
measure: Acute changes during hospitalisation - BATT
timeFrame: One week
measure: Acute changes during hospitalisation - handgrip strength
timeFrame: One week
measure: Rectus femoris echogenicity (quantified using ImageJ software)
timeFrame: Immediately postoperatively, one week postoperatively, and at three months
measure: BATT: subcutaneous tissue ratio (BATT-SCR)
timeFrame: Immediately postoperatively and one week postoperatively
measure: Acute sarcopenia
timeFrame: One week postoperatively
measure: Physical activity - steps taken
timeFrame: One week
measure: Physical activity - steps taken
timeFrame: One month
measure: Physical activity - distance walked
timeFrame: One week
measure: Physical activity - distance walked
timeFrame: One month
measure: Sedentary time
timeFrame: One week
measure: Sedentary time
timeFrame: One month
measure: Acceptability (objective) - refusal
timeFrame: Three months
measure: Acceptability (objective) - missing data
timeFrame: Three months
measure: Acceptability (objective) - drop-outs
timeFrame: Three months
measure: Acceptability (patient-reported)
timeFrame: Three months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Carly Welch, MBChB
role: STUDY_DIRECTOR
affiliation: University of Birmingham
name: Thomas Jackson, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.