SarcopeniaNCT03858192
Understanding Acute Sarcopenia
A study testing Colorectal surgery procedure, Emergency abdominal surgery and Antibiotics in people with Sarcopenia, run by University of Birmingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Colorectal surgery procedure, Emergency abdominal surgery and Antibiotics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 May 2019to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B152GW
Carly Welch, c.welch@bham.ac.uk
Thomas Jackson, t.jackson@bham.ac.uk
About this study
Official title: Understanding Acute Sarcopenia: a Time-limited Cohort Study to Characterise Changes in Muscle Mass and Physical Function in Older Adults Following Hospitalisation
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.
Read the 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?
- Conditions
- Sarcopenia
- Being tested
- Colorectal surgery procedure, Emergency abdominal surgery, Antibiotics
- Keywords
- Acute sarcopenia, muscle, physical function, older adults
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal surgery procedureProcedure or surgery
Elective admission for colorectal surgery
Emergency abdominal surgeryProcedure or surgery
Emergency admission necessitating emergency surgery
AntibioticsDrug
Treatment for infection and reason for admission
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
Secondary outcomes (19)
Short Physical Performance Battery (SPPB)
Change in Short Physical Performance Battery (SPPB) score at (elective cohort)
Measured: Three months
Bilateral Anterior Thigh Thickness (BATT)
Change in BATT (elective and emergency cohorts)
Measured: Three months
Handgrip strength
Change in handgrip strength (elective and emergency cohorts)
Measured: Three months
Acute changes during hospitalisation - gait speed
Change in gait speed within one week of hospitalisation (elective and emergency cohorts)
Measured: One week
Acute changes during hospitalisation - BATT
Change in BATT within one week of hospitalisation (elective and emergency cohorts)
Measured: One week
Acute changes during hospitalisation - handgrip strength
Change in handgrip strength within one week of hospitalisation (elective and emergency cohorts)
Measured: One week
Rectus femoris echogenicity (quantified using ImageJ software)
Change in rectus femoris echogenicity (elective and emergency cohorts)
Measured: Immediately postoperatively, one week postoperatively, and at three months
BATT: subcutaneous tissue ratio (BATT-SCR)
Change in BATT: subcutaneous tissue ratio (BATT-SCR) (elective and emergency cohorts)
Measured: Immediately postoperatively and one week postoperatively
Acute sarcopenia
Incidence of acute sarcopenia (elective and emergency cohorts)
Measured: One week postoperatively
Physical activity - steps taken
Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)
Measured: One week
Physical activity - steps taken
Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)
Measured: One month
Physical activity - distance walked
Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)
Measured: One week
Physical activity - distance walked
Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)
Measured: One month
Sedentary time
Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)
Measured: One week
Sedentary time
Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)
Measured: One month
Acceptability (objective) - refusal
Participant refusal rates (elective and emergency cohorts)
Measured: Three months
Acceptability (objective) - missing data
Missing data (elective and emergency cohorts)
Measured: Three months
Acceptability (objective) - drop-outs
Drop-out rates (elective and emergency cohorts)
Measured: Three months
Acceptability (patient-reported)
Total derived acceptability score as measured by questionnaire upon study completion (elective and emergency cohorts)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start3 May 2019
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Dowager Countess Eleanor Peel Trust, University Hospital Birmingham NHS Foundation Trust, MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research
- Responsible party
- Sponsor
- Investigators
- Carly Welch, MBChB, Study director, University of BirminghamThomas Jackson, MBChB, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858192
- Sponsor's protocol ID
- RG_18-213
- Status last verified
- Jan 2019
- First submitted
- 8 Feb 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29392090Welch 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.
PubMed 30642375Welch 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.
PubMed 33632138Welch 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.
PubMed 32650734
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Acute Sarcopenia: a Time-limited Cohort Study to Characterise Changes in Muscle Mass and Physical Function in Older Adults Following Hospitalisation
- ClinicalTrials.gov ID
- NCT03858192
- Acronym / sponsor ID
- RG_18-213
- Conditions
- Sarcopenia
- Keywords
- Acute sarcopenia, muscle, physical function, older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Dowager Countess Eleanor Peel Trust, University Hospital Birmingham NHS Foundation Trust, MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research
- Study start
- 3 May 2019 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Elective colorectal surgery | Experimental | Procedure: Colorectal surgery procedurePatients who are expected to undergo a major colorectal surgery procedure will be recruited to this study preoperatively and followed-up until three months postoperatively. |
| Emergency abdominal surgery | Experimental | Procedure: Emergency abdominal surgeryPatients 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. |
| Medical patients | Experimental | Drug: AntibioticsPatients 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal surgery procedureElective admission for colorectal surgery | Procedure or surgery | Elective colorectal surgery |
| Emergency abdominal surgeryEmergency admission necessitating emergency surgery | Procedure or surgery | Emergency abdominal surgery |
| AntibioticsTreatment for infection and reason for admission | Drug | Medical patients |
Primary outcome
Physical function
Time frame: Three months
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.
19 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Three months
Bilateral Anterior Thigh Thickness (BATT)
Time frame: Three months
Handgrip strength
Time frame: Three months
Acute changes during hospitalisation - gait speed
Time frame: One week
Acute changes during hospitalisation - BATT
Time frame: One week
Acute changes during hospitalisation - handgrip strength
Time frame: One week
Rectus femoris echogenicity (quantified using ImageJ software)
Time frame: Immediately postoperatively, one week postoperatively, and at three months
BATT: subcutaneous tissue ratio (BATT-SCR)
Time frame: Immediately postoperatively and one week postoperatively
Acute sarcopenia
Time frame: One week postoperatively
Physical activity - steps taken
Time frame: One week
Physical activity - steps taken
Time frame: One month
Physical activity - distance walked
Time frame: One week
Physical activity - distance walked
Time frame: One month
Sedentary time
Time frame: One week
Sedentary time
Time frame: One month
Acceptability (objective) - refusal
Time frame: Three months
Acceptability (objective) - missing data
Time frame: Three months
Acceptability (objective) - drop-outs
Time frame: Three months
Acceptability (patient-reported)
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Background: PubMed 29392090Welch 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.
- Background: PubMed 30642375Welch 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.
- Derived from this study: PubMed 33632138Welch 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.
- Derived from this study: PubMed 32650734Welch 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.
- Overall project website (to be updated throughout course of study)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carly Welch, MBChB study director
University of Birmingham
Thomas Jackson, MBChB, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal surgery procedure, Emergency abdominal surgery and Antibiotics in people with Sarcopenia, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carly Welch, MBChB (+44 (0)121 414 3344, c.welch@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858192, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.