Use of a Digital App to Deliver Home-based Rehabilitative Interventions in Patients Affected by Respiratory Diseases: a Monocentric Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effects of home-based telerehabilitation intervention on self-perceived overall quality of life
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and the mid-term effects of a pulmonary rehabilitation intervention, delivered by digital App, on quality of life of patients affected by respiratory diseases. The App will include a monitored exercise training program based on most recent cardiopulmonary rehabilitation guidelines, including alerts, reminders and educational contents as well as chat and online visits with healthcare professionals to improve patient engagement.
详细描述
The center-based pulmonary rehabilitation (PR) intervention is considered the gold standard for functional recovery, secondary prevention, quality of life improvement and social as well as work reintegration in patients affected by respiratory diseases. Such kind of intervention, when delivered in all its fundamental components (clinical stabilization, functional assessment, physical and respiratory training, counseling, nutritional intervention and psychosocial support), is able to reduce global mortality and is recommended by the major international guidelines.
Despite the high level of recommendation, only a small fraction of patients after the acute hospital phase is currently initiated to PR programs for several reasons, including the limited number of specialized rehabilitation facilities.
This unmet need can cause a potential damage to patients' health (failure to reduce disability, higher risk of further pathological relapses) and generates an increase in social and healthcare costs, especially related to subsequent hospitalizations and loss of working capacity.
In order to fill the gap between PR need and demand, health systems are have to adopt not only organizational changes but also to implement innovative solutions based on new technologies. In particular, wearables and mobile health devices seem to be promising tools to deliver a sort of "light PR intervention" promoting healthier lifestyle, even in the long term.
Primary aim The primary objective of the study is to evaluate the feasibility and the medium-term effect on quality of life, measured by Visual Analogue Scale (VAS) contained in the EuroQoL 5D-5L questionnaire, of a digital home-based telerehabilitation program in patients with chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, pulmonary fibrosis, obesity and long COVID syndrome.
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
- •Diagnosis of COPD with Tiffenau index lower than 70%, FEV1 lower than 80%, asthma, bronchiectasis, pulmonary fibrosis, obesity (BMI higher than 30), long COVID syndrome;
- •Mini-mental status examination higher than 22;
- •Ability to perform a 6MWT with or without assistive devices;
- •Patients discharged from the Pulmonary Rehabilitation Unit less than two weeks before the enrollment;
- •Release of written informed consent
排除标准
- •Simultaneous participation to other research projects;
- •Simultaneous participation to other rehabilitation interventions;
- •High risk of heart failure and/or ventricular dysfunction;
- •High thrombotic risk;
- •Cardiac surgery within 3 months after the study enrollment;
- •High risk of arrhythmias;
- •Atrial fibrillation
- •Moderate to severe valvulopathy;
- •Severe or not adequately controlled respiratory diseases;
- •Hemodynamic instability;
- •Anemia (Hb lower than 10 g/dl);
- •Pregnancy;
- •History of drugs abuse
- •Total or partial inability to use digital devices
- •Barriers to exercise training completion
- •Full-day ventilotherapy
结局指标
主要结局
Effects of home-based telerehabilitation intervention on self-perceived overall quality of life
时间窗: 8 weeks
Rating of EuroQoL 5D-5L Visual Analogue Scale (VAS) score changes: the EuroQoL 5D-5LVAS scale is a graduated line ranging from 0 (worse quality of life) to 100 (better quality of life). Longitudinal changes will be obtained subtracting baseline VAS to VAS at follow-up. A positive score means quality of life improvement, a negative score, a worsening of quality of life.
次要结局
- Effects of home-based telerehabilitation intervention on quality of life(8 weeks)
- Effects of home-based telerehabilitation intervention on exercise tolerance(8 weeks)
- Effects of home-based telerehabilitation intervention on heart rate(8 weeks)
- Effects of home-based telerehabilitation intervention on fatigue during exercise(8 weeks)
- Effects of home-based telerehabilitation intervention on dyspnea perception(8 weeks)
- Effects of home-based telerehabilitation intervention on forced vital capacity (FVC)(8 weeks)
- Effects of home-based telerehabilitation intervention on Tiffeneau index(8 weeks)
- Effects of home-based telerehabilitation intervention on forced expiratory volume in the first second (FEV1)(8 weeks)
- Effects of home-based telerehabilitation intervention on forced expiratory flow (FEF)(8 weeks)