Effects of a Home-based Respiratory Muscle Training on Swallowing Function in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gugging Swallowing screen
研究概览
简要总结
The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment.
详细描述
This study aims to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. The swallowing function will be assessed using specific tools and questionnaires. Secondary outcomes will evaluate the respiratory function. The intervention will have a duration of 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Clinical diagnosis of stroke
- •18 years of age or more
排除标准
- •Cognitive impairment or aphasia that prevents the understanding of instructions.
- •Tracheostomy.
- •Presence of cancer.
- •Patients who present another disease of the central nervous system
- •Absence of neuromotor competence to carry out the respiratory function tests.
- •Central apnea.
- •Hypoventilation-obesity syndrome.
- •Severe cardiorespiratory impairment (hemodynamic instability, pulmonary embolism, recent pneumonothorax, acute hemoptysis, active respiratory infections, recent myocardial infarction, unstable angina, pulmonary hypertension, uncontrolled asthma, or severe chronic obstructive pulmonary disease).
- •Patients with recent otorhinolaryngological, abdominal, or thoracic surgery.
研究组 & 干预措施
Respiratory training added to orofacial exercises
Home-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises.
干预措施: Respiratory training (Device)
Respiratory training added to orofacial exercises
Home-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises.
干预措施: Orofacial exercises (Other)
Orofacial exercises
Standard treatment including orofacial exercises.
干预措施: Orofacial exercises (Other)
结局指标
主要结局
Gugging Swallowing screen
时间窗: Baseline, 6 weeks
Screening test that indicates the need to evaluate the presence of dysphagia. The scores ranges from 0 to 20, with higher scores indicating better performance. Twenty points are the highest score that a patient can attain, and it means normal swallowing ability without aspiration risk.
cough peak flow
时间窗: Baseline, 6 weeks
Evaluation of the strength of cough using a peak flow meter
Swallowing quality of life questionnaire
时间窗: Baseline, 6 weeks
Questionnaire evaluating the impact of swallowing deficits on daily living. The scores range from 0 to 100 metric, with a lower score indicating less quality of life.
次要结局
- Forced expiratory volumen in the first second(Baseline, 6 weeks)
- Respiratory Pressure Meter(Baseline, 6 weeks)
- FEV1/FVC ratio(Baseline, 6 weeks)
- Forced vital capacity(Baseline, 6 weeks)
研究者
Irene Cabrera Martos
Profesor titular de Universidad
Universidad de Granada