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临床试验/NCT02599987
NCT02599987已完成不适用

Effectiveness of Inspiratory Muscle Training in Respiratory Muscle Strength, Chest Wall Volume, Diaphragm Thickness and Mobility in Patients With End-stage Renal Disease: Randomized Clinical Trial

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Respiratory muscle strength

研究概览

简要总结

Background: Patients with chronic kidney disease on hemodialysis may have reduced diffusion capacity, lung function and gas exchange due to mechanical and hemodynamic changes in the respiratory system, and decreased respiratory muscle strength resulting from uremic myopathy. The inspiratory muscle training (IMT) appears as an instrument to improve the inspiratory muscle strength, with positive effects on functional capacity and quality of life of kidney patients, however, the effects of IMT were not addressed in the specific variables of the respiratory system and to date there are no studies on the use of daily training in this population. Objective: To evaluate the effectiveness of daily inspiratory muscle training on respiratory muscle strength, chest wall volume, diaphragm thickness and mobility of end-stage renal disease patients. Methods: A randomized controlled clinical trial to be developed in Cardiopulmonary Physical Therapy Laboratory of the Universidade Federal de Pernambuco (UFPE) during the period from November 2015 to December 2016. The sample is composed of 24 individuals aged 18 and 65, having CKD, to perform hemodialysis for at least twelve months and provide inspiratory muscle weakness. Patients will be divided into two groups, the training group will be IMT with POWER-breathe®, load of 50% of MIP, duration of three sets of 30 inspirations, frequency of two sessions per day, 7 days a week for 8 weeks, since the sham group will be subjected to the same procedure (duration and frequency), but without load. Participants will be assessed before and after intervention through a global assessment form, questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF, diaphragmatic ultrasound, opto-electronic plethysmography, spirometry, manometer and six-minute walk test.

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, Investigator)

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

  • Have a chronic kidney disease
  • Hemodialysis for a minimum period of twelve months
  • Inspiratory muscle weakness, with MIP <80cmH2O for men and <60cmH2O for women

排除标准

  • Neurological deficit
  • Chronic lung disease
  • Severe heart disease (unstable angina and acute myocardial infarction)
  • Decompensated diabetes
  • Infectious disease

结局指标

主要结局

Respiratory muscle strength

时间窗: 2 months

Evaluate by manometer

Diaphragm thickness

时间窗: 2 months

Evaluate by ultrasound

次要结局

  • Pulmonary function(2 months)
  • Quality of life(2 months)
  • Chest wall volume(2 months)
  • Walking distance(2 months)
  • Diaphragm mobility(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ANA IRENE CARLOS DE MEDEIROS

Principal Investigator

Universidade Federal de Pernambuco

研究点 (1)

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