Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-07 @ 4:10 AM
Study NCT ID:
NCT03858192
Status:
UNKNOWN
Last Update Posted:
2019-05-21
First Post:
2019-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Acute Sarcopenia
Sponsor:
University of Birmingham
Organization:
Study Overview
Official Title:
Understanding Acute Sarcopenia: a Time-limited Cohort Study to Characterise Changes in Muscle Mass and Physical Function in Older Adults Following Hospitalisation
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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?
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: