EFFECT OF INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION IN PATIENTS WITH STROKE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
Stroke individuals with hemiplegia often display difficulties in mobility, cardiopulmonary function...etc. All stroke patients had restrictive pulmonary dysfunction. Therefore, respiratory training improves their respiratory capacity, and orthostatic stress mediated respiratory, cardiovascular and autonomic response. Respiratory muscle training interventions are efficient in terms of pulmonary functional parameters. In advanced line, this study will be conducted to evaluate inspiratory muscle trainer effect on autonomic modulation and pulmonary function in stroke patients.
详细描述
The second trigger of death and the most frequent life-threatening neurological disease are now strokes. Stroke is the third main cause of the death & disability in Egypt. According to world health organization; from the total world's population, nearly 18.6 had severe disability and 79.7 million had moderate long-term disability. Respiratory dysfunction is a common complication of stroke, with an incidence of over 60%. Despite the high prevalence of stroke-induced respiratory dysfunction, how disordered breathing influences recovery and cognitive outcomes after ischemic stroke is unknown.
Patients with hemiplegia exhibited diminished respiratory muscle strength and pulmonary function at a more severe motor dysfunction level. Impaired inspiratory muscle strength was associated with reduced balance ability and limitations in activities required for daily living.
in the same line this study will be conducted to find out the effect of inspiratory muscle trainer on autonomic modulation and pulmonary function in patients with stroke.
Sixty chronic hemiplegic patients who aged from 55:65 years old will be recruited, and randomly divided into 2 equal groups; study group will receive threshold inspiratory muscle trainer for 8 weeks (24 sessions) and their medications, and traditional training, where control group will receive their prescribed medications in addition to the same traditional training.
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
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Chronic hemiplegic post stroke patients 'at least 6months'
- •Age ranged 55-65years old.
- •Body mass index ranged from 29.9- 34.9 kg/m2
- •Mini-Mental State Examination (MMSE) scores of 23-27 indicate mild cognitive impairment
- •Did not participate in any selective exercise program for the respiratory muscles before.
- •Participants suffering from orthostatic hypotension a systolic BP decline ≥20 mm Hg or a diastolic BP decline ≥10 mm Hg on position change from sitting to standing.
- •Smokers will be defined as those (who had smoked >400 cigarettes in their lifetime)
排除标准
- •Unstable cardiovascular problems.
- •Asthmatic patient.
- •Implanted pacemaker
- •Patients with chest infection.
- •Patients with pleural diseases.
- •Primary valvular disease.
- •History of spontaneous pneumothorax.
- •Clinically significant peripheral vascular disease.
- •Severe anemia being unable to follow RMT instructions or complete the questionnaires of the study due to cognitive impairment .
- •Previous lung surgery.
- •Long-term oxygen treatment.
- •Patients with chronic renal failure.
- •Any patient enrolled in an anther research study for at least 30 days.
- •Facial affection
研究组 & 干预措施
Study Group
Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension will receive inspiratory muscle training for 30 minutes per day for at least 3 days a week for 8 weeks, medications, and traditional training along 8 weeks.
干预措施: Inspiratory muscle training (Other)
Study Group
Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension will receive inspiratory muscle training for 30 minutes per day for at least 3 days a week for 8 weeks, medications, and traditional training along 8 weeks.
干预措施: Traditional Training (Other)
Control Group
Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension will receive their medications, and traditional training along 8 weeks.
干预措施: Traditional Training (Other)
结局指标
主要结局
Blood Pressure
时间窗: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
systolic, diastolic blood pressure and mean arterial blood pressure those will be measure using Mercury sphygmomanometer and stethoscope (China ,1600G004).
Pulmonary Function test
时间窗: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Pulmonary function test using Spirometry will be used to evaluate (Compact; Vitalograph; Buckingham, England) FVC, FEV1, FEV1 / FVC will be measured three times per each time of evaluation on a computerized spirometer
次要结局
- Functional capacity and orthostatic hypotension assessment(Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).)
- Cognitive function(Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).)
研究者
Adly A Adam
Lecturer of Physical Therapy
Cairo University