Clinical trial NCT06840626: Pilot Study on Breathing Exercises and Pulmonary Function in Children With Cerebral Palsy: A Randomized Trial
Official title: Pilot Study on the Effects of Conductive Breathing Exercises on Pulmonary Function in School-Aged Children With Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
respiratory health
spirometry
CP quality of life
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Center for Translational Medicine
First posted: 2025-02-21
Enrollment: 55
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Forced Expiratory Volume in 1st second (FEV1) in (L)
timeFrame: • Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
measure: Forced Expiratory Volume in 1st second (FEV1) in %
timeFrame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
measure: Forced Vital Capacity (FVC) in (L)
timeFrame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
measure: Forced Vital Capacity (FVC) in %
timeFrame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
measure: FEV1/FVC Ratio
timeFrame: Measured at 0, 8, and 18 weeks.
measure: Peak Expiratory Flow (PEF) in (L/sec)
timeFrame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
measure: Peak Expiratory Flow (PEF) in %
timeFrame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Secondary outcomes:
measure: Cerebral Palsy Quality of Life
timeFrame: measurement at 0 weeks, 8 weeks, 18 weeks
measure: Severity and Frequency of Drooling
timeFrame: measurement at 0 weeks, 8 weeks, 18 weeks
measure: Depression level
timeFrame: measurement at 0 weeks, 8 weeks, 18 weeks
measure: Anxiety level
timeFrame: measurement at 0 weeks, 8 weeks, 18 weeks
measure: Stress level
timeFrame: measurement at 0 weeks, 8 weeks, 18 weeks
measure: Eating Ability
timeFrame: measurement at 0 weeks, 8 weeks, 18 weeks
measure: Drinking Ability
timeFrame: measurement at 0 weeks, 8 weeks, 18 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Conductive Pedagogical Methodology Institution and College.
state: Pest
Study officials:
References: