Technical Validity and Clinical Feasibility of Using a Telerehabilitation System Using Advanced Telehealth Technologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Technical validity of the data transmitted remotely - pulse oximeter - concordance between datasets.
研究概览
简要总结
This prospective study will be held in two steps.
The aim of the first step is to assess the technical validity of transmitting data remotely from different devices connected to a telerehabilitation system. These will include real-time oximetry data during exercise on a cycle ergometer (heart rate and transcutaneous oxygen saturation) as well as daily step count from a commercially available physical activity tracker.
The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment). Briefly, participants will benefit from a eight weeks pulmonary rehabilitation program performed at home, using the telerehabilitation system. Further details about the content of the program and the outcomes are provided below.
详细描述
Before taking part in the study, participants will undergo an incremental cardiopulmonary exercise testing as their baseline assessment before referral to a pulmonary rehabilitation program.
Participants referred for pulmonary rehabilitation to the ADIR Association will be screened for eligibility. They will be contacted to initiate their program. During the first session, they will be offered to participate in the study.
This protocol will be held in two steps : the first step will aim to assess the clinical validity of the data transmitted remotely through the system (from two different devices) and the second step will aim to assess the clinical feasibility of using the system in the home environment.
Participant recruitment for each of these steps will be performed chronologically (the first twenty eligible participants will participate in the technical validity step of the study and the last twenty eligible participants will participate in the clinical feasibility step).
Step one: Clinical validity. The first step of the study aims to assess the clinical validity of data transmitted remotely from two devices connected to the telerehabilitation system (a. oximetry data during exercise and b. daily step count from a commercially available physical activity tracker).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 superior to eighteen years.
- •Stable (> four weeks) chronic obstructive pulmonary disease, GOLD stage II to IV
- •Referred to pulmonary rehabilitation (no contraindication to exercise training on a cycle ergometer).
- •With or without oxygen during exercise.
- •Specific inclusion criteria for the first step of the study:
- •Able to perform forty-five minutes of exercise training on a cycle ergometer.
- •Specific inclusion criteria for the second phase of the study:
- •Person of legal age who may be present during home exercise sessions (relatives).
- •Non-inclusion Criteria:
- •Pregnancy or likely to be.
- •Guardianship.
- •Unable to consent.
- •Referred to pulmonary rehabilitation before lung cancer surgery.
- •Referred to pulmonary rehabilitation before lung volume reduction surgery scheduled in the next few months.
排除标准
- •Consent withdrawal
结局指标
主要结局
Technical validity of the data transmitted remotely - pulse oximeter - concordance between datasets.
时间窗: Data will be recorded immediately after the intervention.
Comparison of paired datasets between the data recorded locally within the internal memory of the pulse oximeter and those collected from the telerehabilitation system.
Technical validity of the data transmitted remotely - physical activity tracker - proportion of sessions transmitted.
时间窗: Data will be recorded immediately after the intervention.
The number of days with physical activity data retrieved from the telerehabilitation system will be expressed in relation to the number of days that the tracker has been worn by the participant.
Technical validity of the data transmitted remotely - physical activity tracker - concordance between datasets.
时间窗: Data will be recorded immediately after the intervention.
Comparison of paired dataset between the daily data, either automatically collected from the telerehabilitation system or self-reported by the participant (visually displayed on the physical activity tracker).
Technical validity of the data transmitted remotely - pulse oximeter - proportion of sessions transmitted.
时间窗: Data will be recorded immediately after the intervention.
The number of exercise sessions retrieved from the telerehabilitation system will be expressed in relation to the number of sessions performed.
Technical validity of the data transmitted remotely - pulse oximeter - number of session required to be autonomous when using the system.
时间窗: Data will be recorded immediately after the intervention.
Participants will be taught to use the system and they will be requested to set data collection autonomously during the four next sessions. They will be considered autonomous when they will be able to set data collection autonomously without error. The number of sessions (after the first session) required to reach autonomy will be collected.
Technical validity of the data transmitted remotely - pulse oximeter - proportion of common usable data.
时间窗: Data will be recorded immediately after the intervention.
The proportion of data without artefacts will be compared between datasets. Artefacts will be identified for heart rate when values indicate two hundred fifty beats per minute and for transcutaneous oxygen saturation when values indicate hundred percent.
次要结局
- Endurance exercise capacity - constant workload exercise testing.(Baseline and immediately after the intervention.)
- Endurance exercise capacity - six-minute walking test.(Baseline and immediately after the intervention.)
- Maximal voluntary isometric quadriceps force.(Baseline and immediately after the intervention.)
- Health status.(Baseline and immediately after the intervention.)
- Endurance exercise capacity - six-minute stepper test.(Baseline and immediately after the intervention.)
- Functional dyspnea.(Baseline and immediately after the intervention.)
- Self-reported quality of life.(Baseline and immediately after the intervention.)
- Anxiety.(Baseline and immediately after the intervention.)
- Depression.(Baseline and immediately after the intervention.)
- Cognitive Function.(Baseline and immediately after the intervention.)
- Usability of the system.(Data will be collected immediately after the intervention.)
- Objective physical activity.(Baseline and immediately after the intervention.)
- Adherence - exercise training.(Data will be collected through study completion, an average of 8 weeks.)
- Adherence - self-management education.(Data will be collected through study completion, an average of 8 weeks.)
- Adherence - symptoms monitoring questionnaires.(Data will be collected through study completion, an average of 8 weeks.)
- Use of the telerehabilitation system.(Data will be collected through study completion, an average of 8 weeks.)
- Satisfaction - standardized questionnaire.(Data will be collected immediately after the intervention.)
- Satisfaction - purpose designed survey.(Data will be collected immediately after the intervention.)
- Emotional perception of the system.(Data will be collected immediately after the intervention.)
- Participant's flow.(Data will be collected immediately after the intervention.)
- Motivation to participate in the program using the telerehabilitation system.(Data will be collected immediately after the intervention.)