Pre-Operative Exercise Challenge In Geriatric Thoracic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Step Tracking Rate
研究概览
简要总结
This study is examining collecting data on steps walked (ambulation) per day by thoracic surgery patients over the age of 65 years-old before surgery.
The name(s) of the study device involved in this study is:
- Fitbit inspire
详细描述
This research study is a Feasibility Study, which is the first-time investigators are examining the use of a Fitbit by thoracic surgery patients over the age of 65 years-old before surgery. The study is looking to see if patients can wear a wrist step-tracker and keep a log of their daily step counts for one week. The study is looking to see if people are willing to keep track of their daily steps, so in the future participants may be provided with step-goals to achieve and their steps prior to surgery can be accurately measured.
This research study involves using a Fitbit tracker to record daily steps over the course of 1 week prior to scheduled surgery. Participants will be given a step tracker in clinic and instructed on its use. During the 1 week period, participants will be called by a study team to check on progress.
After a week, participants will be asked to return the step-tracker and their log either at a scheduled pre-surgery clinic visit or in the pre-operative area which ever comes first.
It is expected that about 30 people will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Aged ≥ 65 years
- •Who are preparing to undergo thoracic surgery at Brigham and Women's Hospital (BWH)
排除标准
- •Patients who are completely non-ambulatory (i.e. wheelchair-bound-patients) *
- •Those who lack capacity to consent due to cognitive disease.
- •Patient for which surgery is felt to be more urgent and therefore performed earlier then our required timeframe for intervention.
- •Patients with cardiac disease or angina for which formal cardiac testing is required for clearance.
- •Our exclusion criteria do not include patients with gait disturbances or those who require assistance devices for ambulation.
结局指标
主要结局
Step Tracking Rate
时间窗: 1 week
Feasibility will be determined by the successful tracking of steps and keeping a diary of step-count for one-week duration. Completion of a minimum of 5/7 days will be considered as a success
Return Rate
时间窗: 1 week
If 90% of trackers are returned, it will be considered a successful return.
Diary of Steps Rate
时间窗: 1 week
Feasibility will be determined by the successful tracking of steps and keeping a diary of step-count for one-week duration. We will consider completion of a minimum of 5/7 days as a success.
Data Retrieval Rate
时间窗: 1 week
assess extraction of the data from the mobility upon return. Success will be considered if 90% of data is retrievable
次要结局
未报告次要终点
研究者
Michael Jaklitsch, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute