"Clinical Trial Randomized, Controlled, Parallel-group and Open About the Use of"TELEMEDICINE"in the Management of the Maintenance of a Respiratory Rehabilitation Program Phase in Patients With Chronic Respiratory Diseases"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months
研究概览
简要总结
Respiratory rehabilitation (RR) has been shown to provide benefits in patients with Chronic Obstructive Pulmonary Disease (COPD) with a degree of evidence A.
These benefits are primarily focused on an increase in the capacity of effort for activities of daily living and in an improvement in the quality of life related to health (HRQOL) a constant to the RR critique is the fact that the benefits achieved with programmes are lost in a progressive and constant way once the patient completes the treatment and lost contact with the team.
The introduction of new technologies in different fields of medicine has been a new approach when it comes to the management of various diseases and treatments in chronic patients. In the case of the RR telemedicine provides a new tool.
COPD disease very prevalent and chronic it is generator of a high economic cost. The possibility of universalizing the rehabilitation treatment would involve a potential savings in this population group ,another potential benefit is as translational trial as part of the development of a new technology and its possible application to clinical practice.
General objective: to determine whether a program of TeleRehabilitation (TeleRR)- Respiratory Rehabilitation Maintenance (RRm) after an intensive initial program of RR, is a useful intervention against the current usual strategy (intensive program of RR and a recommendation of not protected maintenance program).
Method: clinical trial , open, randomized, multicenter, parallel group, and focus of superiority with a strategy of Telerehabilitation program respiratory of maintenance after an intensive RR for 8 weeks in patients diagnosed with grade moderately - severe stable COPD (Bode 3-7).
详细描述
- SELECTION AND WITHDRAWAL OF SUBJECTS
1.1 INCLUSION CRITERIA
To be eligible to participate in this study, subjects must meet the following inclusion criteria:
Patients diagnosed with COPD aged less than 75 years BODE index of 3-7 clinical stability, understood as not having an exacerbation (*) of the COPD and not require treatment with antibiotics, corticoids systemic and/or hospitalization, at least 1 month prior to inclusion in the study. You have been reported to the subject and has been given sufficient time and opportunity to consider their participation has given its consent in writing. Able to use technology the subject is willing and is able to meet all the requirements of the study.
(*) Exacerbation: Exacerbation means worsening of two or more of the following main symptoms for at least 2 consecutive days:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Coded databases
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with COPD
- •age 8 and 75 (both included)
- •index BODE's 3-7 ( BODE Iindex for Body-mass index, airflow Obstruction, Dyspnea, and Exercise)
- •clinical stability, understood as not having an exacerbation (*) of the COPD and do not require treatment with antibiotics, corticoids systemic and/or hospitalization, at least in the 30 days prior to their inclusion
- •has given his consent
- •capable of using technology
- •the subject is willing and is able to meet all the requirements of the study. * Exacerbation : Exacerbation means worsening of two or more of the following main symptoms for at least 2 consecutive days: dyspnea, volume of sputum; Sputum purulence o worsening of any main symptom along with one of the following symptoms for at least 2 consecutive days: sore throat; Cold ( nasal congestion); Fever without any other cause; Cough; Wheezing
排除标准
- •Osteo-muscular pathology that limit or preclude the exercises
- •Presence of heart disease which limit exercise program
- •patients with bronchiectasis or other several of COPD respiratory disorders
- •comorbidity that prevent respiratory rehabilitation of maintenance program
- •less than 2 years life expectancy
- •any unstable medical or psychiatric process or substance abuse which, in the opinion of the investigator, would affect the ability of the patient to complete the study or impede their participation in the study
研究组 & 干预措施
Telemedicine (TeleRR)
The intervention: Telemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance Respiratory Rehabilitation supported by telemedicine (TeleRR).
A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year.
The exercises dates must be sent after doing the training each day by the PDA . The dates will be monitoring by the physician .
干预措施: Telemedicine: Maintenance Respiratory Rehabilitation (Device)
Clinical Practice (Recommendation)
No intervention. A recommendation from standard maintenance respiratory rehabilitation program with a minimum monitoring.
Clinical practice.
结局指标
主要结局
Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months
时间窗: One Year
a).Effectiveness of an Tele Respiratory Rehabiltation program in the maintenance of benefits after an intensive respiratory rehabilitation. outcomes:A/ the distancecovered (meters) in the 6m Walking test B/ health quality questionnaires. Specific respiratory questionaire (CRQ); General questionaire (SF 36) after 12 months of maintenance program.C/Changes in the multidimensional scale BODE. TeleRR program is clinically effective in the medium and long term by keeping the initial benefits of the intensive RR in aspects such as the capacity of effort (distance in meters), HRQOL and BODE .
次要结局
- Specific objective: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] .Safety of TeleRehab (mortality an serious events due related to the program)(One year)
研究者
JUAN B GALDIZ ITURRI
PhD- Neumologist
Hospital de Cruces