Anaemia and Handgrip Strength, a Prospective Observatonal Study Amongst Female Population Planned for Major Elective Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Association between handgrip strength and haemoglobin status within female participants of ProPBM study
研究概览
简要总结
This is a sub-study parallel to ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery (NCT03888768).
Only female participants of ProPBM will be included in this sub-study.
Association between anaemia and handgrip strength and the effect of intravenous iron therapy as part of ProPBM protocol within female participants is elucidated in this study.
详细描述
BACKGROUND:
Maximal physical efforts and aerobic exercise depend highly on adequate oxygen supply provided by haemoglobin and level of iron bound to haemoglobin.
Handgrip strength has been shown to have a strong validity and high reliability in testing the upper body and lower body muscle strength, however its use as a potential tool to identify early anaemic patients planned for surgery is not fully explored. To our knowledge, this study is the first to investigate the diagnostic power of functional performance test within preoperative anaemic population and the change of handgrip strength after administration of intravenous iron.
METHODS:
At recruitment of ProPBM study, all eligible patients for this sub-study will be invited to this sub-study and have their full blood count, ferritin and transferrin saturation recorded and handgrip strength assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients participating in the ProPBM study
- •Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics surgery
- •The patient must be willing and able to provide informed consent for the study
排除标准
- •Patients with known muscle weakness eg myasthenia gravis
- •Patients with cerebrovascular or orthopaedic disease that could influence muscle mass and/or upper body function
- •Patients in which IV iron is contraindicated eg 1st trimester of pregnancy or known allergy or hypersensitivity to parenteral iron
- •Patients with iron overload
结局指标
主要结局
Association between handgrip strength and haemoglobin status within female participants of ProPBM study
时间窗: At recruitment
The dependent variable is concentration of plasma circulating haemoglobin (Hb) taken at recruitment and measured in g/dL. The non-dependant variable is the baseline handgrip strength recorded in kilogram using Jamar hydraulic hand dynamometer. Participants will be positioned in a straight back chair with both hand and feet flat on the ground, elbow flexed to 90 degrees with forearm and wrist in the neutral position. Patient's muscle strength will then be tested three times with an interval of one minute between testing and the average of three times will be recorded to the nearest 0.1kg. The association between anaemia and handgrip strength will be analyzed by using binary logistic regression technique.
次要结局
- Association between handgrip strength and iron status within female participants of ProPBM study(At recruitment)
- Change in handgrip strength in iron deficient female participants of ProPBM study who received intravenous iron(Handgrip strength repeated within 1 month post IV iron administration preoperatively)