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

NCT ID: NCT06840626

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-03-30

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

Series of breathing exercises

Intervention Type: OTHER

During the intervention, participants perform respiratory exercises, including deep breathing, belly breathing, exhalation with vocalization, and forced exhalation. Each exercise is repeated five times, three times per day: twice in the morning and once in the afternoon. The exercises are conducted in a seated, corrected position, guided by rehabilitation specialists or special needs teachers who provide instructions and demonstrations. Teachers are provided with the exact protocol for the breathing exercises series. Each breathing exercise focuses on maintaining a specific rhythm, with inhalation lasting approximately 3-4 seconds, holding for 1-2 seconds, and exhalation for 5-6 seconds. Forced exhalation is facilitated using playful motivational tools such as windmills and balloon blowing. The protocol includes instructions for the breathing exercises in first-person singular. The entire session lasts approximately 5 minutes, resulting in a total of 15 minutes of training per day.

Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Series of breathing exercises

During the intervention, participants perform respiratory exercises, including deep breathing, belly breathing, exhalation with vocalization, and forced exhalation. Each exercise is repeated five times, three times per day: twice in the morning and once in the afternoon. The exercises are conducted in a seated, corrected position, guided by rehabilitation specialists or special needs teachers who provide instructions and demonstrations. Teachers are provided with the exact protocol for the breathing exercises series. Each breathing exercise focuses on maintaining a specific rhythm, with inhalation lasting approximately 3-4 seconds, holding for 1-2 seconds, and exhalation for 5-6 seconds. Forced exhalation is facilitated using playful motivational tools such as windmills and balloon blowing. The protocol includes instructions for the breathing exercises in first-person singular. The entire session lasts approximately 5 minutes, resulting in a total of 15 minutes of training per day.

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Translational Medicine

OTHER

Sponsor Role: collaborator

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Semmelweis University, Conductive Pedagogical Methodology Institution and College.

Budapest, Pest County, Hungary

Countries

Hungary

Other Identifiers

SE11568780

Identifier Type: -

Identifier Source: org_study_id