Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Borg scale in six-minute walk test
研究概览
简要总结
Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic response, pulmonary function and exercise capacity.
Non-pharmacological interventions are low cost and can significant enhance outcomes in these patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable therapeutic approach in patients with functional limitations, particularly those that present with difficulty to perform exercise protocols.
Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality of life of patients with PH.
Material and methods: prospective randomized controlled study with a control group (GC, n9) and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk test (6MWT) were assessed before and after the NMES protocol.
Results: the GE presented with a significant improvement in distance walked in the 6MWT, cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and social aspects of the questionnaire Short Form Health Survey-36.
Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved exercise capacity, quality of life and lung function testing.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females greater than or equal to 18 years of age, clinically stable with optimized drug therapy in the last 3 months, previously diagnosed with a mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization and who agreed to participate by signing an informed consent were included.
排除标准
- •Exclusion criteria included a diagnosis of Down syndrome, orthopedic disease or neurologic or diagnoses, history of acute heart attack, use of beta-blockers, any urgent or elective surgical intervention during the implementation of the protocol, those who used assistive devices to ambulate or develop an infectious process during the study protocol.
结局指标
主要结局
Borg scale in six-minute walk test
时间窗: change from baseline in Borg scale at 2 months
analysis of Borg scale at end of test
Systolic blood pressure in six-minute walk test
时间窗: change from baseline in systolic blood pressure at 2 months
analysis of systolic blood pressure at end of test
Diastolic blood pressure in six-minute walk test
时间窗: change from baseline in diastolic blood pressure at 2 months
analysis of diastolic blood pressure at end of test
Distance in six-minute walk test
时间窗: change from baseline in distance at 2 months
analysis of distance
Oxygen saturation in six-minute walk test
时间窗: change from baseline in oxygen saturation at 2 months
analysis of oxygen saturation at end of test
Heart rate in six-minute walk test
时间窗: change from baseline in heart rate at 2 months
analysis of heart rate at end of test
次要结局
- Forced vital capacity(change from baseline at 2 months)
- Forced expiratory volume in the first second(change from baseline at 2 months)
- The Medical Outcomes Study 36-item Short Form Health Survey(change from baseline at 2 months)
- Forced expiratory flow 25-75 %(change from baseline at 2 months)
- Ratio of forced expiratory volume in the first second and forced vital capacity(change from baseline at 2 months)
研究者
Profa. Dra. Vera Lúcia dos Santos Alves
PHD
Faculdade de Ciências Médicas da Santa Casa de São Paulo