NCT02523521Unknown不适用
Impacte d'un Programa d'Exercici Per Nens d'Entre 4 a 6 Anys Amb Displàsia Broncopulmonar
Hospital de Nens de Barcelona2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- aerobic capacity measured by shuttle run test
研究概览
简要总结
The purpose of this study is to determine the effects of a physical activity program for children with Bronchopulmonary Dysplasia.
详细描述
Primary objectives is: to compare exercise tolerance and aerobic capacity between healthy children with Bronchopulmonary Dysplasia children Only Bronchopulmonary Dysplasia children will realise the physical activity program.
Secondary objectives are: to analyse lung function and to evaluate flexibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bronchopulmonary Dysplasia Children
- •Inclusion Criteria:
- •age between 4 to 6 years old
- •Bronchopulmonary Dysplasia diagnostic
- •ex-prematurity
- •accept to participate.
排除标准
- •congenital malformations
- •neuromuscular disorders
- •gait alterations
- •difficulties for communication and understanding
- •wheezing or pulmonary disease two weeks before to start the program
- •hemodynamic changes (heart rate > 130bpm, systolic blood pressure > 130bpm, diastolic blood pressure > 80bpm).
- •heart and/or lung transplantation.
- •Healthy children Criteria:
- •Inclusion Criteria:
- •age between 4 to 6 years old.
- •Exclusion Criteria:
- •antecedents of pulmonary or cardiac chronic disease
- •congenital malformations
- •neuromuscular disorders
- •gait alterations
- •difficulties for communication and understanding
- •wheezing or pulmonary disease two weeks before to start the program
- •hemodynamic changes (heart rate > 130bpm, systolic blood pressure > 130bpm, diastolic blood pressure > 80bpm).
- •heart and/or lung transplantation.
研究组 & 干预措施
Bronchopylmonary Dysplasia Control
No Intervention
Nothing
Bronchopylmonary Dysplasia Intervention
Experimental
physical activity program.
干预措施: Physical activity program (Behavioral)
Healthy children
No Intervention
Nothing.
结局指标
主要结局
aerobic capacity measured by shuttle run test
时间窗: 15 minutes
effort tolerance measured by six minute walking test
时间窗: six minutes
次要结局
- lung function measured by spirometry(5 minutes)
- flexibility measured by sit and reach test(2 minutes)
研究者
Morales
physiotherapist
Hospital de Nens de Barcelona
研究点 (2)
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