Understanding Acute Sarcopenia

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858192
• Other study ID #: RG_18-213
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2019
• Est. completion date: September 2021

Study information

• Verified date: January 2019
• Source: University of Birmingham
• Contact: Carly Welch, MBChB
• Phone: +44 (0)121 414 3344
• Email: c.welch[@]bham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: September 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Procedure:
• Colorectal surgery procedure
Elective admission for colorectal surgery
• Emergency abdominal surgery
Emergency admission necessitating emergency surgery

Drug:
• Antibiotics
Treatment for infection and reason for admission

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham	West Midlands

Sponsors (4)

Lead Sponsor	Collaborator
University of Birmingham	Dowager Countess Eleanor Peel Trust, MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research, University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

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

External Links

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