Effects of Inspiratory Muscle Training on Lung Function, Inspiratory Muscle Strength and Trunk Balance in Patients With Stroke in Subacute Phase.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Voluntary maximum ventilation
研究概览
简要总结
Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease
详细描述
Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease. The intervention will be done in a group of patients who will be treated in the rehabilitation service at the Virgen de la Arrixaca Hospital. They will train using a threshold IMT device or a Powerbreathe device, to increase their inspiratory muscle strength in addition to a physical therapy treatment. The intervention will last eigtht weeks and the patients will be evaluated at the beginning and at the end of the intervention.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study is blinded so neither the patient, neither the psysical therapist nor the investigator knows in which group the patient is
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sroke 6 months before of the beginning of the study
- •Be able to understand simple commands
- •Hemiparesis or hemiplegia
- •Not have serious cardiopulmonary diseases(COPD,asthma,bronchiectasis)
排除标准
- •Associated neurological pathology leading to muscle weakness
- •Severe respiratory pathology, pulmonary embolism, presence of tracheostomy cannula,
- •intracranial hypertension
- •Acute retinal datachment, recent eye surgery
- •Impossibility of labial occlusion
- •Unstable heart disease, unstable angina, aortic aneurysm
- •Recent thoracic or abdominal surgery(6 months)
- •Uncontrolled arterial hypertension
研究组 & 干预措施
IMT-GE
the participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will increase from the 15% of the maximal inspiratory preassure until the 60% of the maximal inspiratory preassure.
干预措施: IMT (Device)
IMT-GP
The participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will be the 10% of the maximal inspiratory preassure during all the 8 weeks
干预措施: IMT (Device)
结局指标
主要结局
Voluntary maximum ventilation
时间窗: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer
The "Berg balance scale" Test
时间窗: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the balance at the beginning and in the end of the intervention using the berg balance scale tool. The máximum value of this scale is 56 points, and the mínimum is 0 points. A higher value represents a better outcome.
Maximum inspiratory pressure
时间窗: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks
Forzed espiratory volume in the first second
时间窗: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer
Trunk control test (TCT)
时间窗: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the trunk control at the beginning and in the end of the intervention. The maximum value is 100 points, and the minimum 0 points. Higher values represents a better outcome
Forzed vital capacity
时间窗: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the forzed vital capacity from the beginning and at the end of the intervention
The postural assessment scale for stroke patients (PASS )test
时间窗: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the balance of the trunk at the beginning and in the end of the intervention using the postural assessment scale for stroke patinents tool. The maximum value of tris scale is 36 points. The minimum is 0 points.Higher values represents a better outcome.
次要结局
- Quadriceps dynamometry(From the first day of evaluation and at eight weeks of the beginning of the intervention)
- "Functional ambulatory classificator Hospital de Sagunto" Test(From the first day of evaluation and at Eight weeks of the beginning of the intervention)
- SF-36 health survey(From the first day of evaluation and at eight weeks of the beginning of the intervention)
- "Functional ambulatory classificator" Test(From the first day of evaluation and at Eight weeks of the beginning of the intervention)
研究者
Alicia Tovar Alcaraz
Physical therapist
Hospital Universitario Virgen de la Arrixaca