Investigation of the Effects of Neuromuscular Electrical Stimulation in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Isometric muscle strength
研究概览
简要总结
This study aimed to investigate the effects of neuromuscular electrical stimulation on peripheral muscles and other physical and psychosocial variables in patients with pulmonary arterial hypertension. This study was designed as an assessor-blind randomized controlled trial. Thirty-one patients with pulmonary arterial hypertension will be recruited. The participants will randomly divided two parallel groups as treatment and control. For the treatment group, neuromuscular electrical stimulation will be applied to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks. Control group will not be received any additional treatment, just given healthy life recommendations such as walking. The participants will be assessed before and after the treatment by a blind assessor to the group allocation. The outcome measure will be assessments of the upper and lower limb muscle strength, respiratory muscle strength, muscle cross-sectional area and thickness, pulse wave velocity, exercise capacity, walking speed, functional mobility and balance performances, balance confidence, fatigue perceptions, physical activity level, activities of daily living and quality of life.
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
- 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
- •Elevated pulmonary artery pressures measured by right heart catheterization
- •New York Heart Association class II or III
- •Stabile Pulmonary Arterial Hypertension-specific pharmaceutical therapy for 3 months
排除标准
- •Orthopaedic problems
- •Significant restrictive or obstructive pulmonary disease
- •Acute cor pulmonale.
研究组 & 干预措施
Neuromuscular electrical stimulation intervention
Neuromuscular electrical stimulation treatment
干预措施: Neuromuscular electrical stimulation (Device)
Control
No additional intervention
结局指标
主要结局
Isometric muscle strength
时间窗: Change from Baseline at 8 weeks
Isometric muscle strength for knee extensors
次要结局
- Six-Minute Pegboard and Ring Test(Change from Baseline at 8 weeks)
- Sit-to-Stand Test(Change from Baseline at 8 weeks)
- Timed-Up and Go Test(Change from Baseline at 8 weeks)
- Six-Minute Walk Test(Change from Baseline at 8 weeks)
- Isometric muscle strength(Change from Baseline at 8 weeks)
- Hand grip strength(Change from Baseline at 8 weeks)
- Quadriceps femoris muscle thickness(Change from Baseline at 8 weeks)
- Rectus femoris cross-sectional area(Change from Baseline at 8 weeks)
- Pulse wave velocity(Change from Baseline at 8 weeks)
- Activities-specific Balance Confidence Scale(Change from Baseline at 8 weeks)
- 4-m Gait Speed Test(Change from Baseline at 8 weeks)
- Fatigue Impact Scale(Change from Baseline at 8 weeks)
- International Physical Activity Questionnaire-Short Form(Change from Baseline at 8 weeks)
- Milliken Activities of Daily Living Scale(Change from Baseline at 8 weeks)
- Nottingham Health Profile(Change from Baseline at 8 weeks)
研究者
Buse Ozcan Kahraman
Principal Investigator
Dokuz Eylul University