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临床试验/NCT03153124
NCT03153124已完成不适用

Effects of Respiratory Muscle Training in Muscle Force, Functional Capacity and Quality of Life in Hemodialysis Patients

Faculdade de Ciências Médicas da Santa Casa de São Paulo2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年4月12日最近更新:
适应症

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

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

发起方
Faculdade de Ciências Médicas da Santa Casa de São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Profa. Dra. Vera Lúcia dos Santos Alves

PHD

Faculdade de Ciências Médicas da Santa Casa de São Paulo

研究点 (2)

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