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Understanding Acute Sarcopenia

Primary Purpose

Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Colorectal surgery procedure
Emergency abdominal surgery
Antibiotics
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcopenia focused on measuring Acute sarcopenia, muscle, physical function, older adults

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Queen Elizabeth Hospital BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Elective colorectal surgery

Emergency abdominal surgery

Medical patients

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Short Physical Performance Battery (SPPB)
Change in Short Physical Performance Battery (SPPB) score at (elective cohort)
Bilateral Anterior Thigh Thickness (BATT)
Change in BATT (elective and emergency cohorts)
Handgrip strength
Change in handgrip strength (elective and emergency cohorts)
Acute changes during hospitalisation - gait speed
Change in gait speed within one week of hospitalisation (elective and emergency cohorts)
Acute changes during hospitalisation - BATT
Change in BATT within one week of hospitalisation (elective and emergency cohorts)
Acute changes during hospitalisation - handgrip strength
Change in handgrip strength within one week of hospitalisation (elective and emergency cohorts)
Rectus femoris echogenicity (quantified using ImageJ software)
Change in rectus femoris echogenicity (elective and emergency cohorts)
BATT: subcutaneous tissue ratio (BATT-SCR)
Change in BATT: subcutaneous tissue ratio (BATT-SCR) (elective and emergency cohorts)
Acute sarcopenia
Incidence of acute sarcopenia (elective and emergency cohorts)
Physical activity - steps taken
Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)
Physical activity - steps taken
Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)
Physical activity - distance walked
Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)
Physical activity - distance walked
Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)
Sedentary time
Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)
Sedentary time
Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)
Acceptability (objective) - refusal
Participant refusal rates (elective and emergency cohorts)
Acceptability (objective) - missing data
Missing data (elective and emergency cohorts)
Acceptability (objective) - drop-outs
Drop-out rates (elective and emergency cohorts)
Acceptability (patient-reported)
Total derived acceptability score as measured by questionnaire upon study completion (elective and emergency cohorts)

Full Information

First Posted
February 8, 2019
Last Updated
May 17, 2019
Sponsor
University of Birmingham
Collaborators
Dowager Countess Eleanor Peel Trust, University Hospital Birmingham NHS Foundation Trust, MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research
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1. Study Identification

Unique Protocol Identification Number
NCT03858192
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2019 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
Collaborators
Dowager Countess Eleanor Peel Trust, University Hospital Birmingham NHS Foundation Trust, MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Acute sarcopenia, muscle, physical function, older adults

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elective colorectal surgery
Arm Type
Experimental
Arm 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.
Arm Title
Emergency abdominal surgery
Arm Type
Experimental
Arm 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.
Arm Title
Medical patients
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Colorectal surgery procedure
Intervention Description
Elective admission for colorectal surgery
Intervention Type
Procedure
Intervention Name(s)
Emergency abdominal surgery
Intervention Description
Emergency admission necessitating emergency surgery
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Intervention Description
Treatment for infection and reason for admission
Primary Outcome Measure Information:
Title
Physical function
Description
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
Change in Short Physical Performance Battery (SPPB) score at (elective cohort)
Time Frame
Three months
Title
Bilateral Anterior Thigh Thickness (BATT)
Description
Change in BATT (elective and emergency cohorts)
Time Frame
Three months
Title
Handgrip strength
Description
Change in handgrip strength (elective and emergency cohorts)
Time Frame
Three months
Title
Acute changes during hospitalisation - gait speed
Description
Change in gait speed within one week of hospitalisation (elective and emergency cohorts)
Time Frame
One week
Title
Acute changes during hospitalisation - BATT
Description
Change in BATT within one week of hospitalisation (elective and emergency cohorts)
Time Frame
One week
Title
Acute changes during hospitalisation - handgrip strength
Description
Change in handgrip strength within one week of hospitalisation (elective and emergency cohorts)
Time Frame
One week
Title
Rectus femoris echogenicity (quantified using ImageJ software)
Description
Change in rectus femoris echogenicity (elective and emergency cohorts)
Time Frame
Immediately postoperatively, one week postoperatively, and at three months
Title
BATT: subcutaneous tissue ratio (BATT-SCR)
Description
Change in BATT: subcutaneous tissue ratio (BATT-SCR) (elective and emergency cohorts)
Time Frame
Immediately postoperatively and one week postoperatively
Title
Acute sarcopenia
Description
Incidence of acute sarcopenia (elective and emergency cohorts)
Time Frame
One week postoperatively
Title
Physical activity - steps taken
Description
Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)
Time Frame
One week
Title
Physical activity - steps taken
Description
Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)
Time Frame
One month
Title
Physical activity - distance walked
Description
Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)
Time Frame
One week
Title
Physical activity - distance walked
Description
Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)
Time Frame
One month
Title
Sedentary time
Description
Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)
Time Frame
One week
Title
Sedentary time
Description
Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)
Time Frame
One month
Title
Acceptability (objective) - refusal
Description
Participant refusal rates (elective and emergency cohorts)
Time Frame
Three months
Title
Acceptability (objective) - missing data
Description
Missing data (elective and emergency cohorts)
Time Frame
Three months
Title
Acceptability (objective) - drop-outs
Description
Drop-out rates (elective and emergency cohorts)
Time Frame
Three months
Title
Acceptability (patient-reported)
Description
Total derived acceptability score as measured by questionnaire upon study completion (elective and emergency cohorts)
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carly Welch, MBChB
Phone
+44 (0)121 414 3344
Email
c.welch@bham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carly Welch, MBChB
Organizational Affiliation
University of Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas Jackson, MBChB, PhD
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B152GW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carly Welch
Email
c.welch@bham.ac.uk
First Name & Middle Initial & Last Name & Degree
Thomas Jackson
Email
t.jackson@bham.ac.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
29392090
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.
Results Reference
background
PubMed Identifier
30642375
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.
Results Reference
background
PubMed Identifier
33632138
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.
Results Reference
derived
PubMed Identifier
32650734
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.
Results Reference
derived
Links:
URL
http://acutesarcopenia.wordpress.com
Description
Overall project website (to be updated throughout course of study)

Learn more about this trial

Understanding Acute Sarcopenia

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