Ventilatory Functions Response to Bicycle Ergometry Training in Boys With Duchenne Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Forced Vital Capacity (FVC)
研究概览
简要总结
The purpose of the study is to investigate the effect of bicycle ergometry training on ventilatory functions in boys with Duchenne muscular dystrophy.
详细描述
Duchenne muscular dystrophy (DMD) is a common genetic X chromosome-linked recessive muscular dystrophy. It causes deterioration in mobility, progressive deformities in musculoskeletal system, upper limb impairment, and impaired airway clearance. Deterioration in respiratory muscles is the major cause of mortality and morbidity in DMD in their second to the third decade as a secondary complication in respiratory and cardiovascular systems. Cycling exercise is an easy functional treatment that considered as an aerobic exercise used to improve ventilatory functions, strength of respiratory muscles and therefore prevents respiratory diseases. Several studies support the benefit of bicycle ergometry training on ventilatory functions in different diseases while, there is no research conducted its effect on Duchenne muscular dystrophy. Hence, there is need to study the effect of bicycle ergometry training on ventilatory functions in Duchenne muscular dystrophy.
Thirty boys with Duchenne muscular dystrophy aged from 8-10 years will be recruited from Abu El-Rish Pediatric Hospital. They will be divided randomly into control group (15 boys) and study group (15 boys). Control group will be participated in designed physical therapy program. Study group will be trained on the bicycle ergometer in addition to the same designed physical therapy program participated in control group.
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
- 8 Years 至 10 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Boys ages will be ranged from 8 to 10 years old.
- •Confirmed diagnosis as Duchenne muscular dystrophy.
- •Lower limb functional levels ranged from Grades 1 through 3 acc. to Vignos scale for lower extremities.
- •Still ambulant and able to sit independently for at least 1 hour.
排除标准
- •Ccongenital or acquired skeletal deformities or cardiopulmonary dysfunction.
- •Previous orthopaedic surgery in lower limbs.
- •Behavioral problems causing inability to cooperate during the study.
结局指标
主要结局
Forced Vital Capacity (FVC)
时间窗: Up to 12 weeks
Spirometry will be used to measure forced vital capacity (FVC). It is the maximum volume of gas that can be expired when the child exhales as forcefully and as rapidly as possible after a maximal inspiration to assess the overall ability to move air in and out of the lungs. It is expressed in liter/minute.
Forced Expiratory Volume in the First Second (FEV1)
时间窗: Up to 12 weeks
Spirometry will be used to measure forced expiratory volume in the first second (FEV1). It is the volume of gas expired over a given time interval (the first second) from the beginning of the FVC maneuver that reflects airflow in the large airways. It is expressed in liter/minute.
Forced Expiratory Volume in the First Second/Forced Vital Capacity Ratio (FEV1/FVC%)
时间窗: Up to 12 weeks
Spirometry will be used to measure forced expiratory volume in the first second/forced vital capacity ratio (FEV1/FVC%). It is the relationship between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) to determine if the respiratory pattern is obstructive, restrictive or normal pattern. It is expressed in (%).
次要结局
- Ambulatory status assessment(Up to 12 weeks)
研究者
Eman Wagdy
lecturer
Beni-Suef University