Pilot Study on the Effects of Conductive Breathing Exercises on Pulmonary Function in School-Aged Children With Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Forced Expiratory Volume in 1st second (FEV1) in (L)
研究概览
简要总结
This pilot study is a randomized controlled trial aimed at investigating the efficacy of protocolized conductive breathing exercises combined with regular air ventilation, in addition to standard care, on various aspects of health in school-aged children with cerebral palsy (CP). The primary objectives of the study include assessing the effects on pulmonary functions, quality of life (QoL), depression anxiety and stress (DAS) levels, eating-drinking ability (EDACS), and severity of drooling in this population.
The study compares two groups of participants: one group undergoes protocolized conductive breathing exercises three times per day for five minutes, five days a week, while the other group receives only standard rehabilitation care. Evaluations include spirometry parameters ( forced vital capacity [FVC] forced expiratory volume in the first second [FEV1], FEV1/FVC ratio and peak expiratory flow [PEF]. Assessments are conducted at the beginning and end of the eight weeks intervention period, with additional evaluations after a 2.5-month washout period.
The conductive breathing exercises, developed by Dr. András Pető, the founder of the conductive education system, consist of techniques such as diaphragmatic breathing, deep breathing, and playful forced expiration.
Respiratory well-being is crucial, particularly in pediatric CP patients, as compromised pulmonary functions can significantly impact overall health. Despite this, there is currently a lack of established protocols and research regarding the efficacy of conductive breathing exercises in this specific population. Therefore, the this study seeks to address this gap by determining whether a structured regimen of conductive breathing exercises, when added to standard care, can lead to measurable improvements in respiratory health and QoL among school-aged children with CP.
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, Care Provider)
盲法说明
The study employs double-blinded, whereby participants are unaware of their assigned treatment, and professionals are also unaware of whether they belong to the control or intervention group. The school-age children with CP in the study could only be randomised on the basis of class membership. The classes were separated, and the professionals involved were unaware of which group was assigned to the intervention or control. The professionals in the control group were provided with a breathing protocol that incorporated sham breathing tasks.
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Inclusion Criteria:
- •Children with cerebral palsy (GMFCS I-V)
- •School-Aged 12-22 years, of both genders
- •Teens and adolescents attending continuous standard care
- •Capable of understanding and following commands given by the therapist
- •Children who do not require respiratory support
排除标准
- •Children who have received recent surgical procedures or botulinum toxin injections
- •Children who are unable to perform spirometry
结局指标
主要结局
Forced Expiratory Volume in 1st second (FEV1) in (L)
时间窗: • Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Change from baseline in forced expiratory volume in 1st second (FEV1) * Description: FEV1 is the maximal volume of air that can be expired in the first second of forced vital capacity maneuver using spirometry. * Units of Measure: L (Liter)
Forced Expiratory Volume in 1st second (FEV1) in %
时间窗: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Change from baseline in forced expiratory volume in 1st second (FEV1) • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards.
Forced Vital Capacity (FVC) in (L)
时间窗: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
* Description: FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry. * Units of Measure: L (Liter)
Forced Vital Capacity (FVC) in %
时间窗: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry. • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards:
FEV1/FVC Ratio
时间窗: Measured at 0, 8, and 18 weeks.
Description: This is already a combined measurement (a ratio of Forced Expiratory Volume in the first second to Forced Vital Capacity). No unit.
Peak Expiratory Flow (PEF) in (L/sec)
时间窗: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry. Units of Measure: L/sec (Liter/secundum)
Peak Expiratory Flow (PEF) in %
时间窗: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry. • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards.
次要结局
- Cerebral Palsy Quality of Life(measurement at 0 weeks, 8 weeks, 18 weeks)
- Severity and Frequency of Drooling(measurement at 0 weeks, 8 weeks, 18 weeks)
- Depression level(measurement at 0 weeks, 8 weeks, 18 weeks)
- Anxiety level(measurement at 0 weeks, 8 weeks, 18 weeks)
- Stress level(measurement at 0 weeks, 8 weeks, 18 weeks)
- Eating Ability(measurement at 0 weeks, 8 weeks, 18 weeks)
- Drinking Ability(measurement at 0 weeks, 8 weeks, 18 weeks)