NCT03858192

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 21, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

February 8, 2019

Last Update Submit

May 17, 2019

Conditions

Sarcopenia

Keywords

Acute sarcopenia, muscle, physical function, older adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Short Physical Performance Battery (SPPB)

    Three months

  • Bilateral Anterior Thigh Thickness (BATT)

    Three months

  • Handgrip strength

    Three months

  • Acute changes during hospitalisation - gait speed

    One week

  • Acute changes during hospitalisation - BATT

    One week

  • +14 more secondary outcomes

Study Arms (3)

Elective colorectal surgery

EXPERIMENTAL

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

Emergency abdominal surgery

EXPERIMENTAL

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

Medical patients

EXPERIMENTAL

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

Interventions

Colorectal surgery procedurePROCEDURE

Elective admission for colorectal surgery

Elective colorectal surgery
Emergency abdominal surgeryPROCEDURE

Emergency admission necessitating emergency surgery

Emergency abdominal surgery
AntibioticsDRUG

Treatment for infection and reason for admission

Medical patients

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, B152GW, United Kingdom

RECRUITING

Related Publications (4)

  • 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.

    PMID: 29392090BACKGROUND

  • 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.

    PMID: 30642375BACKGROUND

  • 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.

    PMID: 33632138DERIVED

  • 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.

    PMID: 32650734DERIVED

Related Links

MeSH Terms

Conditions

Sarcopenia

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Carly Welch, MBChB

    University of Birmingham

    STUDY DIRECTOR

  • Thomas Jackson, MBChB, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carly Welch, MBChB

CONTACT

+44 (0)121 414 3344c.welch@bham.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 28, 2019

Study Start

May 3, 2019

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

May 21, 2019

Record last verified: 2019-01

Locations

GB(1)