Understanding Acute Sarcopenia

NCT ID: NCT03858192

Last Updated: 2019-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-03

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 (PROMISĀ®). 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?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective cohort study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elective colorectal surgery

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.

Group Type EXPERIMENTAL

Colorectal surgery procedure

Intervention Type PROCEDURE

Elective admission for colorectal surgery

Emergency abdominal surgery

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.

Group Type EXPERIMENTAL

Emergency abdominal surgery

Intervention Type PROCEDURE

Emergency admission necessitating emergency surgery

Medical patients

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

Group Type EXPERIMENTAL

Antibiotics

Intervention Type DRUG

Treatment for infection and reason for admission

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colorectal surgery procedure

Elective admission for colorectal surgery

Intervention Type PROCEDURE

Emergency abdominal surgery

Emergency admission necessitating emergency surgery

Intervention Type PROCEDURE

Antibiotics

Treatment for infection and reason for admission

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dowager Countess Eleanor Peel Trust

UNKNOWN

Sponsor Role collaborator

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role collaborator

MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research

UNKNOWN

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carly Welch, MBChB

Role: STUDY_DIRECTOR

University of Birmingham

Thomas Jackson, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carly Welch, MBChB

Role: CONTACT

+44 (0)121 414 3344

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Carly Welch

Role: primary

Thomas Jackson

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29392090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30642375 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33632138 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32650734 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://acutesarcopenia.wordpress.com

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RG_18-213

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sarcopenia and Aging
NCT00907010 COMPLETED
Muscle Biopsies in Healthy Volunteers
NCT01431677 TERMINATED NA