Noninvasive Ventilatory Support Associated With Concurrent Training in Improved Functional Capacity and Quality of Life in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- SIX MINUTES WALK TEST
研究概览
简要总结
Due to the symptoms of heart failure (HF), as dyspnea and fatigue, patients have a reduced functional capacity, evidenced during usual daily activities and exercises. The Cardiac Rehabilitation with emphasis on resistance and aerobic exercises performed in the same session (concurrent training), can be added to pharmacological treatment as improvement strategy in functional capacity and quality of life.
详细描述
A randomized clinical trial, divided into two stages will be held. In step 1 the function will be assessed by the 6-minute walk test, spirometry, and questionnaires to evaluate quality of life. After fulfilled the series of assessments individuals will be randomly divided into two groups, with group 1 (control) will hold only one interval aerobic exercise program on treadmill and group 2 (intervention) will hold a combined exercise program for prior use of ventilatory support noninvasive. For both groups will be held an aerobic exercise program associated with resistance exercise for 12 weeks. The first two weeks will be considered in period. In the 10 weeks following both groups maintain the preset exercise program gradually. In the intervention group will be added before the exercise program the use of noninvasive ventilation for 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Will be included 60 patients of both sexes, adults with medical diagnosis divided into two groups: Group A consisted of 30 patients use non-invasive ventilation added to interval training and group B consisted of 30 patients also only use interval training.
排除标准
- •Will be excluded from the study patients who have chest pain (angina), arrhythmias, spo2 ≤ 90%, hypertension or hypotension, neurological or osteoarticular disease preventing the ambulation of these individuals.
结局指标
主要结局
SIX MINUTES WALK TEST
时间窗: AFTER 12 WEEKS FOLLOW
Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
次要结局
- double product(AFTER 12 WEEKS FOLLOW)
- spirometry(AFTER 12 WEEKS FOLLOW)
- minnesota questionnaire(AFTER 12 WEEKS FOLLOW)
- SF-36 questionnaire(AFTER 12 WEEKS FOLLOW)
- Functional Independence Measure questionnaire(AFTER 12 WEEKS FOLLOW)
研究者
Mansueto Gomes Neto
Physiotherapy course coordinator
Federal University of Bahia