Pilot Study on Breathing Exercises and Pulmonary Function in Children With Cerebral Palsy: A Randomized Trial

Not Applicable

Active, not recruiting

• Conditions: Cerebral Palsy

• Registration Number: NCT06840626
• Lead Sponsor: Semmelweis University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-15
• Status Verified: 2024-05
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Exclusion Criteria

• Children who have received recent surgical procedures or botulinum toxin injections
• Children who are unable to perform spirometry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1st second (FEV1) in (L)	• 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 %	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)	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 %	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	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)	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 %	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.

Secondary Outcome Measures

Name	Time	Method
Cerebral Palsy Quality of Life	measurement at 0 weeks, 8 weeks, 18 weeks	The CP QoL test measures changes in quality of life (QoL) across different domains, such as social and emotional well-being, acceptance, bodily pain, and functioning. The assessment is conducted at three time points: 0 weeks, 8 weeks, and 18 weeks.; Scoring and Interpretation: Scale: Scores are recorded from 1 to 9, where 1 = Very unhappy and 9 = Very happy. Higher scores indicate better quality of life (QoL).
Severity and Frequency of Drooling	measurement at 0 weeks, 8 weeks, 18 weeks	The severity and frequency of drooling will be assessed for changes.
Depression level	measurement at 0 weeks, 8 weeks, 18 weeks	Depression Scale (DAS-D): Measures symptoms of depression such as low mood, hopelessness, and loss of interest.; • Scale Details: * Minimum Score: \[0\]; * Maximum Score: \[28\]; In this scale, higher scores represent worse outcomes (indicating more severe depression symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of depression).
Anxiety level	measurement at 0 weeks, 8 weeks, 18 weeks	Anxiety Scale (DAS-A): Assesses symptoms related to anxiety, including nervousness, panic, and fear.; Scale Details: * Minimum Score: \[0\]; * Maximum Score: \[20\] In this scale, higher scores represent worse outcomes (indicating more severe anxiety symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of anxiety).
Stress level	measurement at 0 weeks, 8 weeks, 18 weeks	Stress Scale (DAS-S): Evaluates stress-related symptoms like irritability, tension, and difficulty relaxing.; Scale Details: * Minimum Score: \[0\]; * Maximum Score: \[34\] In this scale, higher scores represent worse outcomes (indicating more severe stress symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of stress).
Eating Ability	measurement at 0 weeks, 8 weeks, 18 weeks	Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids.
Drinking Ability	measurement at 0 weeks, 8 weeks, 18 weeks	Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids.

Trial Locations

Locations (1)

Semmelweis University, Conductive Pedagogical Methodology Institution and College.; 🇭🇺 Budapest, Pest, Hungary