Effects of Respiratory Muscle Training in Muscle Force, Functional Capacity and Quality of Life in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Distance in six-minute walk test
研究概览
简要总结
Patients with chronic kidney disease in hemodialysis have complex syndrome with diverse effects on cardiovascular, nervous, respiratory, musculoskeletal, immune and endocrine-metabolic systems. With regard to the musculoskeletal structure, there is progressive muscular loss with consequent increase in muscle weakness, limited resistance, exercise intolerance and fatigue, as well as functional and morphological abnormalities characteristic of uremic myopathy. Respiratory muscles are also affected as a result of uremic myopathy, with decreased strength and resistance. Objective: to analyze the impact of respiratory muscle training on muscle strength, functional capacity and quality of life of patients with chronic kidney disease on hemodialysis. Method: This is a prospective, randomized study involving 46 patients followed by the dialysis unit of a university hospital, over 18 years old, of both genders who underwent hemodialysis for more than six months and who signed the informed consent form. Patients will be allocated into two groups: respiratory muscle training with PowerBreath and control. All will be evaluated for demographic data, respiratory muscle strength, lung function, functional capacity and quality of life. The intervention group will perform three months of intradialytic training of a physical therapy protocol with PowerBreath. Both groups will be reevaluated after three months.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic kidney disease undergoing hemodialysis for more than 6 months Both genders
- •ged 18 years or older
- •clinically stable
- •who agreed to participate in the study by signing a free informed consent form
排除标准
- •Patients with previous or current myoarticular or neurological disease;
- •That require some urgent or elective surgical intervention during the protocol;
- •Any cardiac decompensation such as arrhythmias, systolic blood pressure greater than 200mmHg or less than 60mmHg, diastolic blood pressure greater than 120mmHg or less than 40mmHg;
- •Decompensated diabetes mellitus and acute systemic infection
结局指标
主要结局
Distance in six-minute walk test
时间窗: change from baseline in distance at 3 months
analysis of distance
Spirometry
时间窗: Change from baseline in Pulmonary Function at 3 months
Pulmonary Function
HRR1
时间窗: change from HR six minute walk test and seven minute
heart rate recovery
Manovacuometry
时间窗: Change from baseline in respiratory muscle force at 3 months
RESPIRATORY MUSCLE FORCE
Quality of life questionnaire
时间窗: change from baseline in quality of life at 3 months
Analysis of the quality of life
次要结局
未报告次要终点
研究者
Profa. Dra. Vera Lúcia dos Santos Alves
PHD
Faculdade de Ciências Médicas da Santa Casa de São Paulo
