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临床试验/NCT03776526
NCT03776526已完成不适用

Researching the Effects of Sleep on Step Count During the Postoperative Period Following Surgery for Hip Fracture

Christopher Patterson1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Number of steps per 24-hour day taken by patients during hospital admission after hip fracture repair.

研究概览

简要总结

Patients over the age of 65 who are admitted to the Juravinski Hospital for treatment of hip fractures will be invited to take part in the study. An activity monitor (a Fitbit® Alta HR) will be attached to the participant post-operatively, to record quality of sleep and amount of activity for the duration of hospital stay. The time spent in hospital and whether complications or confusion develops will also be recorded. The aim is to determine whether poor sleep affects recovery after hip fracture surgery.

详细描述

The purpose of this study is to examine the influence of sleep duration and quality on post-operative mobility in older adults admitted to hospital with a hip fracture. The hypothesis is that poor sleep will independently predict low post-operative mobility (measured by number of steps). Recent developments in activity monitor technology allow for the collection of reliable assessments of movement and sleep rhythm during surgical recovery.

The Fitbit® Alta HR activity monitor will be used for this study. When the participant is awake and alert after surgery and informed consent has been obtained, a study team member will fasten the Fitbit® device on the wrist of the participants' non-dominant hand. Investigators will monitor sleep quality and daily steps taken for the duration of hospitalization, with the option to discontinue if clinically required or requested by the patient or provider. At the time of discharge, the wearable biosensor will be reset and the information will be erased from its memory. The wearable biosensors will be cleaned with disinfectant used for durable medical equipment.

The study population will include patients aged 65+ admitted with hip fracture to the orthopedic ward (E2) at the Juravinski Hospital. Descriptive data on patients admitted with hip fracture will be collected including age, gender, Charlson comorbidity index, diagnosis of dementia, pre-hospital living accommodation, mobility aids, level of pre-admission mobility using the functional independence measure (FIM), and number of beds per room. Timing of surgery (within 24 hours, 48 hours, or more than 48 hours) after admission, highest reported daily pain score and foley catheter use will also be collected from the medical record. The use of sleep medications will be tracked each night during the study period. The physiotherapy notes will be screened for information on total distance ambulated in meters and in-hospital mobility progression. Post-operative complications such as Stroke, Cardiac event, Pneumonia, Venous thromboembolism, GI tract bleed, Urinary tract infections, Postoperative anemia, Acute Kidney Injury, and Pressure sores will be tracked from the medical record. Investigators will also contact participants by phone after 30 days have elapsed since discharge to inquire about mortality, FIM score and location of disposition.

The primary outcome is the total number of steps taken by participants during each 24-hour period after surgery for hip fracture. Mean daily steps will be calculated based on the number of days the activity monitor was worn. Secondary outcomes will be delirium prevalence, hospital length of stay, post-operative complications, 30-day post-discharge mortality, mobility status (FIM - locomotion subscale score), and location of disposition. The primary behavioural exposure is monitoring of sleep duration (measured by total sleep time in minutes) and quality (number of awakenings per night). Daytime naps will also be recorded.

One of the key strengths of this study is that both the primary outcome and the key exposure are measured using a single device, which improves the reliability and efficiency of data collection

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 recovering from surgery for hip fracture
  • •65 years of age or older
  • •Able to provide informed consent or has a substitute decision maker able to provide consent

排除标准

  • •Bed or wheelchair bound prior to fracture
  • •Physical barrier to placement of device (wrist restraints, cast for wrist fracture)
  • •Non-operative hip fractures
  • •Pathologic hip fracture

结局指标

主要结局

Number of steps per 24-hour day taken by patients during hospital admission after hip fracture repair.

时间窗: Through study completion, on average 1 week

Mean daily step count as measured by Fitbit®

次要结局

  • Delirium rate (incidence)(Through study completion, on average 1 week)
  • Length of stay in hospital(Through study completion, on average 1 week)
  • Post-operative complications(Through study completion, on average 1 week)
  • 30-day post-discharge mortality(30 days post discharge)
  • 30 day mobility status(30 days post discharge)
  • Location of disposition(Through study completion, on average 1 week)
  • Location of disposition at 30 days(30 days post discharge)

研究者

发起方
Christopher Patterson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christopher Patterson

Professor Emeritus

McMaster University

研究点 (1)

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