Effects of Home-based Respiratory Muscle Training by Telerehabilitation on Quality of Life, Cardiopulmonary Function, Physical Status and Psychological Status in Individuals With Ischemic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Health related quality of life
研究概览
简要总结
The main objective of the present study is to verify whether respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles), applied by telerehabilitation, is an effective intervention (versus placebo and versus inspiratory muscle training in isolation (IMT)) in improving quality of life, cardiopulmonary function and physical and psychological state in people with ischemic heart disease. In addition, the aim is to determine whether respiratory muscle training (IMT or IMT+EMT) is effective in enhancing the results obtained by a conventional cardiac rehabilitation programme on the aforementioned variables.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Presence of ischemic heart disease
- •Age 18 years or older
- •Cardiovascular clinical stability
排除标准
- •Any condition that contraindicate exercise training
- •Inability to close the lips to hold the training device's mouthpiece (e.g., facial paralysis)
- •Previous participation in a rehabilitation programme within the last 3 months
- •Pregnancy
- •Inability to adhere to remote monitoring
研究组 & 干预措施
Inspiratory muscle training group + Exercise training
Participants in this group will perform a home-based inspiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
干预措施: Inspiratory muscle training (Other)
Inspiratory muscle training group + Exercise training
Participants in this group will perform a home-based inspiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
干预措施: Conventional cardiac rehabilitation programme (Other)
Inspiratory muscle training sham group + Exercise training
Participants in this group will perform a home-based sham inspiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
干预措施: Sham inspiratory muscle training (Other)
Inspiratory muscle training sham group + Exercise training
Participants in this group will perform a home-based sham inspiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
干预措施: Conventional cardiac rehabilitation programme (Other)
Inspiratory and expiratory muscle training group + Exercise training
Participants in this group will perform a home-based inspiratory and expiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
干预措施: Combined inspiratory and expiratory muscle training (Other)
Inspiratory and expiratory muscle training group + Exercise training
Participants in this group will perform a home-based inspiratory and expiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
干预措施: Conventional cardiac rehabilitation programme (Other)
Inspiratory and expiratory muscle training Sham group + Exercise training
Participants in this group will perform a home-based sham inspiratory and expiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
干预措施: Sham combined inspiratory and expiratory muscle training (Other)
Inspiratory and expiratory muscle training Sham group + Exercise training
Participants in this group will perform a home-based sham inspiratory and expiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
干预措施: Conventional cardiac rehabilitation programme (Other)
结局指标
主要结局
Health related quality of life
时间窗: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
EuroQol-five-dimensional Questionnaire A numerical value represented Health state as EQ-5D 'index values' or 'index scores' reflecting how good or bad a health state is. The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
次要结局
- Upper limb strenght(Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks))
- Respiratory muscle strength(Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks))
- Inspiratory muscle endurance(Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks))
- Anxiety and depression levels(Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks))
- Modified Medical Research Council Dyspnoea Scale(Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks))
- Fatigue(Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks))
- Cardiopulmonary function: level of exercise capacity(Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks))
- Strength and endurance of the lower limbs(Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks))
研究者
Ibai López de Uralde Villanueva
Tenure-track professor with a PhD in the Department of Radiology, Physiotherapy and Rehabilitation
Universidad Complutense de Madrid