Understanding Acute Sarcopenia: a Time-limited Cohort Study to Characterise Changes in Muscle Mass and Physical Function in Older Adults Following Hospitalisation
试验速览
- 阶段
- 不适用
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Physical function
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Colorectal surgery procedure (Procedure)
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.
干预措施: Emergency abdominal surgery (Procedure)
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
干预措施: Antibiotics (Drug)
结局指标
主要结局
Physical function
时间窗: 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.
次要结局
- Short Physical Performance Battery (SPPB)(Three months)
- Bilateral Anterior Thigh Thickness (BATT)(Three months)
- Acceptability (patient-reported)(Three months)
- Handgrip strength(Three months)
- Acute changes during hospitalisation - gait speed(One week)
- Acute changes during hospitalisation - BATT(One week)
- Acute changes during hospitalisation - handgrip strength(One week)
- Rectus femoris echogenicity (quantified using ImageJ software)(Immediately postoperatively, one week postoperatively, and at three months)
- BATT: subcutaneous tissue ratio (BATT-SCR)(Immediately postoperatively and one week postoperatively)
- Acute sarcopenia(One week postoperatively)
- Physical activity - steps taken(One month)
- Physical activity - distance walked(One month)
- Sedentary time(One month)
- Acceptability (objective) - refusal(Three months)
- Acceptability (objective) - missing data(Three months)
- Acceptability (objective) - drop-outs(Three months)