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

Semmelweis University

Status: Active, not recruiting

Conditions: Cerebral Palsy

Treatments: Other: Series of breathing exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06840626

SE11568780

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 12 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

In this group, participants received conductive education as standard rehabilitation care plus the procolized breathing exercesis. In this group, participants followed a strict protocol for breathing exercises over an 8-week period, performing them three times a day, Monday through Friday, for five minutes each session. They also adhered to prescribed ventilation guidelines, in addition to receiving standard rehabilitation care.

Treatment:

Other: Series of breathing exercises

Control Arm

No Intervention group

Description:

In this group, participants received conductive education as standard rehabilitation care plus sham breathing exercises. Participants in this group followed a strict 8-week protocol for breathing exercises, which included a sham breathing protocol, performing the exercises three times a day, Monday through Friday, for one minutes each session.