An interventional study of Protocolized breathing exercises and Sham Breathing Exercises in Cerebral Palsy, sponsored by Semmelweis University. Not yet recruiting at 1 site in Hungary. Open to participants aged 12 Years to 22 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Semmelweis University · Not applicable, Interventional, and Treatment
This multicenter randomized controlled pilot trial evaluates whether an 8-week protocolized breathing exercise program improves pulmonary function and quality of life in adolescents and young adults with cerebral palsy. Participants are randomized to either a structured breathing exercise program added to usual pedagogical rehabilitation care or sham breathing exercises plus usual care.
The study assesses changes in spirometric outcomes (FVC, FEV₁, PEF) and patient-reported quality of life and emotional well-being. Participants complete respiratory assessments and questionnaires at baseline, post-intervention, and follow-up.
This multicenter randomized controlled pilot trial investigates the effects of a structured, protocolized breathing exercise program on pulmonary function and quality of life in adolescents and young adults with cerebral palsy (CP).
The study builds on evidence that individuals with CP are at increased risk of respiratory impairment due to motor dysfunction, reduced mobility, postural limitations, and oropharyngeal dysphagia, all of which may contribute to restrictive lung disease and long-term respiratory complications. In addition, individuals with CP frequently experience reduced quality of life and increased levels of emotional distress, including anxiety, depression, and stress.
The intervention is based on breathing exercises derived from the Conductive Education System (CES), a pedagogical rehabilitation care that integrates motor, cognitive, and functional training for individuals with CP. Although breathing exercises are commonly included in pedagogical rehabilitation practice, their clinical effectiveness has not previously been systematically evaluated.
Participants are adolescents and young adults aged approximately 12-22 years with a diagnosis of cerebral palsy, representing a wide range of motor severity (Gross Motor Function Classification System levels I-V). The study will conducted across multiple conductive education centers to increase generalizability and to reflect real-world rehabilitation settings.
Participants will randomized at the class or group level to either an intervention group or a control group. The intervention group receives an 8-week structured breathing exercise program in addition to standard care. The program consists of short, guided daily sessions (approximately 15 minutes per day), including deep breathing, abdominal breathing, controlled inhalation and exhalation patterns, and forced expiration exercises using simple aids (e.g., balloons or windmills). The control group receives usual care and performs sham breathing activities for only 3 minutes/day. During the sham condition, participants are instructed only to breathe naturally without performing any structured or guided breathing exercises. This approach is intended to control for attention and environmental exposure without providing active respiratory training.
Primary outcomes include pulmonary function measures assessed by spirometry, specifically forced vital capacity (FVC), forced expiratory volume in 1 second (FEV₁), and peak expiratory flow (PEF). Secondary outcomes include quality of life, emotional distress (depression, anxiety, and stress), eating and drinking ability, and drooling severity, all assessed using standardized validated questionnaires and classification tools.
Assessments are performed at baseline, immediately after the 8-week intervention, and at follow-up approximately 18 weeks after baseline. The study also explores whether motor function level (GMFCS) influences responsiveness to the intervention.
The main aim of this pilot trial is to evaluate the feasibility and generate preliminary evidence regarding the potential benefits of structured breathing exercises in this population.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's planned enrollment of 360 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Semmelweis University is the lead sponsor of 139 studies on the registry; 55 are open to participants now.
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Exclusion Criteria
In this group, participants receive pedagogical rehabilitation as standard rehabilitation care plus the procolized breathing exercesis. In this group, participants follow 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. During the intervention, participants perform respiratory exercises, including deep breathing, abdominal 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.
Behavioral: Protocolized breathing exercises
In this group, participants receive pedagogical rehabilitation 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.During the sham condition, participants are instructed only to breathe naturally without performing any structured or guided breathing exercises. T
Behavioral: Sham Breathing Exercises
The investigator developed a protocolized breathing program based on a systematic review of Dr. András Pető's work. Exercises were designed to be simple and easily guided by video or a trained therapist. The intervention group receives an 8-week structured breathing exercise program in addition to standard care. The program consists of short, guided daily sessions (approximately 15 minutes per day), including deep breathing, abdominal breathing, controlled inhalation and exhalation patterns, and forced expiration exercises using simple aids (e.g., balloons or windmills). Therapists guided participants through a standardized rhythm (3-4 s inhalation, 1-2 s hold, 5-6 s exhalation), using playful tools such as windmills or balloons for forced exhalation.
The control group receives usual care and performs sham breathing activities for only 3 minutes/day. During the sham condition, participants are instructed only to breathe naturally without performing any structured or guided breathing exercises. This approach is intended to control for attention and environmental exposure without providing active respiratory training.
Peak Expiratory Flow (PEF), Percentage of Predicted Value
The primary outcome will asses the change in PEF measured by spirometry and will be performed by trained staff in accordance with the 2019 ATS/ERS Standardization of Spirometry Statement , using a validated Piston PDD 301/sh spirometer with standard accessories. Pulmonary parameters will be assessed in an upright sitting position using a spirometer with a nose clip, ensuring a tight lip seal around the mouthpiece. Higher values indicate greater peak expiratory flow.
Time frame: Measurements at baseline (week 0) , week 8.
Peak Expiratory Flow (PEF), Percentage of Predicted Value
Description: The primary outcome will asses the change in PEF measured by spirometry and will be performed by trained staff in accordance with the 2019 ATS/ERS Standardization of Spirometry Statement , using a validated Piston PDD 301/sh spirometer with standard accessories. PEF will be assessed in an upright sitting position using a spirometer with a nose clip, ensuring a tight lip seal around the mouthpiece. Higher values indicate greater peak expiratory flow.
Time frame: Measurements at week 18
Peak Expiratory Flow (PEF), Liters per Second
Peak expiratory flow (PEF) will be measured by spirometry and reported in liters per second (L/s). Higher values indicate greater peak expiratory flow.
Time frame: Measurements at baseline (week 0) , week 8, week 18
Forced Vital Capacity (FVC), Percentage of Predicted Value
Forced vital capacity (FVC) will be measured by spirometry and expressed as a percentage of the predicted value. Higher values indicate greater forced vital capacity relative to the predicted value.
Time frame: Measurements at baseline (week 0) , week 8, week 18
Forced Vital Capacity (FVC), Liters
Forced vital capacity (FVC) will be measured by spirometry with participants in an upright sitting position. FVC will be reported in liters (L). Higher values indicate greater forced vital capacity.
Time frame: Baseline (week 0), week 8, and week 18
Forced Expiratory Volume in One Second (FEV1), Percentage of Predicted Value
Forced expiratory volume in one second (FEV1) will be measured by spirometry and expressed as a percentage of the predicted value. Higher values indicate greater forced expiratory volume in one second relative to the predicted value.
Time frame: Baseline (week 0), week 8, and week 18
Forced Expiratory Volume in One Second (FEV1), Liters
Forced expiratory volume in one second (FEV1) will be measured by spirometry with participants in an upright sitting position. FEV1 will be reported in liters (L). Higher values indicate greater forced expiratory volume in one second.
Time frame: Baseline (week 0), week 8, and week 18
Quality of Life: Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen)
The Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) self-report will be used to assess health-related quality of life. The questionnaire assesses the following domains: general well-being and participation, communication, functioning, family and friends, school, social and emotional well-being, acceptance, and pain.The domains are scored on a 0-100 scale, with higher scores indicating better quality of life.
Time frame: Baseline (week 0), week 8, and week 18
Psychological Distress
Psychological distress will be assessed using the Depression Anxiety Stress Scales - 42 Items (DASS-42). The DASS-42 comprises three subscales assessing depression, anxiety, and stress. The total score is calculated by summing the scores of all 42 items and ranges from 0 to 126. Higher scores indicate greater psychological distress.
Time frame: Baseline (week 0), week 8, and week 18
Eating and drinking abilities
The Eating and Drinking Ability Classification System (EDACS) classifies eating and drinking ability in people with cerebral palsy according to the safety and efficiency of oral intake. The classification ranges from Level I to Level V. Level I indicates that the person eats and drinks safely and efficiently, whereas Level V indicates that the person is unable to eat or drink safely. Higher levels indicate greater limitations in eating and drinking ability.
Time frame: Measurements at baseline (week 0) , week 8, week 18
Severity and Frequency of Drooling
Drooling severity and frequency will be assessed using the Drooling Severity and Frequency Scale (DSFS), a standardized measure used to evaluate the extent and occurrence of drooling. Higher scores indicate greater drooling severity and frequency.
Time frame: Measurements at baseline (week 0) , week 8, week 18
Plan to share: No — De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator.
No publications or documents are linked to this record.
Start is estimated for Apr 2027; primary completion for Sep 2027, 5 months later.
Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 5 months is below that.
Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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