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Understanding Acute Sarcopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858192
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
Dowager Countess Eleanor Peel Trust
University Hospital Birmingham NHS Foundation Trust
MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research
Information provided by (Responsible Party):
University of Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcopenia Procedure: Colorectal surgery procedure Procedure: Emergency abdominal surgery Drug: Antibiotics Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Understanding Acute Sarcopenia: a Time-limited Cohort Study to Characterise Changes in Muscle Mass and Physical Function in Older Adults Following Hospitalisation
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: Colorectal surgery procedure
Elective admission for colorectal surgery
Experimental: 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.
 Procedure: Emergency abdominal surgery
Emergency admission necessitating emergency surgery
Experimental: 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
 Drug: Antibiotics
Treatment for infection and reason for admission


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: Three months ]
    Change in Short Physical Performance Battery (SPPB) score at (elective cohort)

  2. Bilateral Anterior Thigh Thickness (BATT) [ Time Frame: Three months ]
    Change in BATT (elective and emergency cohorts)

  3. Handgrip strength [ Time Frame: Three months ]
    Change in handgrip strength (elective and emergency cohorts)

  4. Acute changes during hospitalisation - gait speed [ Time Frame: One week ]
    Change in gait speed within one week of hospitalisation (elective and emergency cohorts)

  5. Acute changes during hospitalisation - BATT [ Time Frame: One week ]
    Change in BATT within one week of hospitalisation (elective and emergency cohorts)

  6. Acute changes during hospitalisation - handgrip strength [ Time Frame: One week ]
    Change in handgrip strength within one week of hospitalisation (elective and emergency cohorts)

  7. Rectus femoris echogenicity (quantified using ImageJ software) [ Time Frame: Immediately postoperatively, one week postoperatively, and at three months ]
    Change in rectus femoris echogenicity (elective and emergency cohorts)

  8. BATT: subcutaneous tissue ratio (BATT-SCR) [ Time Frame: Immediately postoperatively and one week postoperatively ]
    Change in BATT: subcutaneous tissue ratio (BATT-SCR) (elective and emergency cohorts)

  9. Acute sarcopenia [ Time Frame: One week postoperatively ]
    Incidence of acute sarcopenia (elective and emergency cohorts)

  10. Physical activity - steps taken [ Time Frame: One week ]
    Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)

  11. Physical activity - steps taken [ Time Frame: One month ]
    Postoperative physical activity (steps taken) as measured by physical activity recorders (subset of elective and emergency cohorts)

  12. Physical activity - distance walked [ Time Frame: One week ]
    Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)

  13. Physical activity - distance walked [ Time Frame: One month ]
    Postoperative physical activity (distance walked) as measured by physical activity recorders (subset of elective and emergency cohorts)

  14. Sedentary time [ Time Frame: One week ]
    Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)

  15. Sedentary time [ Time Frame: One month ]
    Postoperative sedentary time as measured by physical activity recorders (subset of elective and emergency cohorts)

  16. Acceptability (objective) - refusal [ Time Frame: Three months ]
    Participant refusal rates (elective and emergency cohorts)

  17. Acceptability (objective) - missing data [ Time Frame: Three months ]
    Missing data (elective and emergency cohorts)

  18. Acceptability (objective) - drop-outs [ Time Frame: Three months ]
    Drop-out rates (elective and emergency cohorts)

  19. Acceptability (patient-reported) [ Time Frame: Three months ]
    Total derived acceptability score as measured by questionnaire upon study completion (elective and emergency cohorts)


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858192


Contacts
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Contact: Carly Welch, MBChB +44 (0)121 414 3344 c.welch@bham.ac.uk

Locations
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United Kingdom
Queen Elizabeth Hospital Birmingham Recruiting
Birmingham, West Midlands, United Kingdom, B152GW
Contact: Carly Welch       c.welch@bham.ac.uk   
Contact: Thomas Jackson       t.jackson@bham.ac.uk   
Sponsors and Collaborators
University of Birmingham
Dowager Countess Eleanor Peel Trust
University Hospital Birmingham NHS Foundation Trust
MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research
Investigators
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Study Director: Carly Welch, MBChB University of Birmingham
Principal Investigator: Thomas Jackson, MBChB, PhD University of Birmingham
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT03858192    
Other Study ID Numbers: RG_18-213
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Birmingham:
Acute sarcopenia, muscle, physical function, older adults
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
 Atrophy
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Anti-Infective Agents