Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 1st session of 45 of aerobic training.
研究概览
简要总结
The purpose of this study is to assess the feasibility and the reliability of a telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease.
The feasibility is assessed using the patient's satisfaction and it ease of use.
The reliability of the remote telemonitoring system is assessed comparing the local data (extracted from the monitoring device itself) and the data transmitted through the telemonitoring platform.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years ;
- •Chronicle obstructive pulmonary disease stage II/III/IV (FEV1 < 80%) ;
- •Referred for pulmonary rehabilitation.
排除标准
- •Pregnant woman or likely to be ;
- •Patient under guardianship ;
- •Neuropathic disorder ;
- •Contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation ;
- •Progressive cancer.
结局指标
主要结局
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 1st session of 45 of aerobic training.
时间窗: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 2nd session of 45 of aerobic training.
时间窗: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 5th session of 45 of aerobic training.
时间窗: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 3rd session of 45 of aerobic training.
时间窗: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 4th session of 45 of aerobic training.
时间窗: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
次要结局
- Patient's satisfaction assessed by Likert scale.(5 sessions for 5 different patients will be assessed for a total time frame a 6month. Outcome will be assessed during the final session of every patient.)
- Reliability between the transcutaneous saturation (SpO2) acquired directly with the oximeter (Nonin 3150) and SpO2 provided by the telemedicine gateway.(HR is assessed during 5 training sessions of 45min for a total time frame of 2month.)
- Reliability of the telemedicine gateway in providing data.(5 sessions of 45min will be carried out for 5 patients for a total time frame of 4months. For every patient, sessions will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions).)
- Ability of the patients to be autonomous when using the device.(5 sessions for 5 different patients will be assessed for a total time frame a 6month. Data will be collected after every sessions and presented as the number of patients autonomous when using the device.)