Feasibility Study to Assess if Using the 6 Minute Walk Test at a Patients First Visit to Surgical Outpatients Will Identify Those Individuals With a Significantly Reduced Level of Cardiorespiratory Fitness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Can all the patients invited to 6MWT complete the walk test
研究概览
简要总结
The aim of this study is to assess the feasibility of using the 6 minute walk test (6MWT) as a cardiorespiratory fitness (CRF) screening tool. The screening would take place when the patient attends the hospital for their initial surgical outpatient appointment. By screening all potential major intra-abdominal surgery patients for a period of 6 months and recording the distance walked in the 6 minutes (6MWD) the aim is to produce a threshold distance for the patients of Sheffield that would identify those with sufficient CRF what would allow them to proceed to surgery without further investigations or fitness interventions.
Having identified the fit it would allow the perioperative team to focus resources on the less fit with the aim of improving CRF and other elements that would lead to reduced postoperative morbidity and mortality.
Other primary aims include noting the time to surgery. This data will inform on wither instigation of the early screening test would facilitate enrolment and completion of an exercise programme before surgery.
The secondary aim is to assess the relationship between the 6MWD and routine CPET to confirm if those that walk the furthest are in fact the fittest.
详细描述
This is a prospective observational study that would run for a period of 6 months. The population proceeding to undergo major abdominal surgery is estimated to be 500 patients a year. The primary aim is to invite all patients being considered for major abdominal surgery to participate in a simple screening test of fitness, the 6 minute walk test (6MWT).
Potential participants would be identified by the participating surgical teams during their first visit to this institutions Surgical Outpatient Department (SOPD). Upon identification the individual would be provided with information designed to be read on returning to the waiting area from the SOPD clinic room.
The study walker, who would be an appropriately trained research nurse or outpatient clinic support worker, would approach the patient to answer questions and provide further information if required. Consent for participation would then be obtained. The participating individual would then be walked the short distance to the testing area and would be offered a seat whilst the 6MWT procedure was explained in more detail. Time would be allowed for questions. The 6MWT would be then conducted as per the American Thoracic Society guidance. Heart rate will be recorded manually both at baseline and at the cessation of the test.
Following the 6MWT patients could either depart the hospital or return to the SOPD if it was felt a period of recovery was required.
The 6 minute walk distance (6MWD) would be recorded against the patient's participant study identification number. Patient identifiers that would link the patient study number to a particular patient would be stored safely behind lock and key or encryption when electronic. The case report forms will be paper to allow timely collection of data and this information will be collated onto a spreadsheet which will facilitate future analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Considered for major abdominal surgery who can weight bear
排除标准
- •Considered for major surgery who cannot weight bear
- •Unable to follow the verbal instructions on walking test procedure provided by the researcher
研究组 & 干预措施
Single Arm
6 Minute Walking Test
干预措施: 6 minute walk test (Other)
结局指标
主要结局
Can all the patients invited to 6MWT complete the walk test
时间窗: Day 1
Number of participants who are able to complete the walk test at their first visit
Distance walked by the participants during the 6MWT measured in meters
时间窗: Day 1
measured in meters completed
The duration in time between the walk test and the participant attending for surgery
时间窗: within 60 days of original single point measurement
measured in days
次要结局
- Correlation between the distance walked during the 6 minute walk test and anaerobic threshold as measured by cardiopulmonary exercise testing (CPET) in ml/kg/min.(for 90 days beyond the closure of the study)
- Correlation between the distance walked during the 6 minute walk test and peak oxygen consumption as measured by cardiopulmonary exercise testing (CPET) in ml/kg/min.(for 90 days beyond the closure of the study)