Cerebral PalsyNCT07873593
The Effects of Protocolized Breathing Exercises on Pulmonary Function in Adolescents With Cerebral Palsy.
A study testing Protocolized breathing exercises in people with Cerebral Palsy, run by Semmelweis University at 1 site in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Protocolized breathing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteHungary
- Study dates
- 5 Apr 2027to 6 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and young adults with a diagnosis of CP
- GMFCS Levels I to V
- Ages ≥12 to ≤22 years
- Ability to perform spirometry
- Ability to follow instructions
- Informed consent signed by legal guardian
Who cannot join
- Use of respiratory support in the past 12 months
- Botulinum toxin injections within 12 months prior to enrolment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
Semmelweis University András Pető Faculty
Budapest, Pest County, 1125
About this study
Official title: The Effects of Protocolized Breathing Exercises on Pulmonary Function and Quality of Life in School-aged Children With Cerebral Palsy
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.
Read the detailed description
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.
- Conditions
- Cerebral Palsy
- Being tested
- Protocolized breathing exercises, Sham Breathing Exercises
- Keywords
- quality of life, cerebral palsy, pulmonary function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized breathing exercisesBehavioural
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.
Sham Breathing ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: Protocolized breathing exercises |
| Control | Sham comparator | 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 Receives: Behavioral: Sham Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements at baseline (week 0) , week 8.
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measurements at baseline (week 0) , week 8, week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start5 Apr 2027 (estimated)
- Primary completion6 Sep 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ibolya Túri, PhD, Principal investigator, Semmelweis Egyetem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873593
- Sponsor's protocol ID
- SE_PAK_KEB/2024/001
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Protocolized Breathing Exercises on Pulmonary Function and Quality of Life in School-aged Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07873593
- Acronym / sponsor ID
- SE_PAK_KEB/2024/001
- Conditions
- Cerebral Palsy
- Keywords
- quality of life, cerebral palsy, pulmonary function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 5 Apr 2027 (estimated)
- Primary completion
- 6 Sep 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Protocolized breathing exercisesIn 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. |
| Control | Sham comparator | Behavioral: Sham Breathing ExercisesIn 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 |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children and young adults with a diagnosis of CP
- GMFCS Levels I to V
- Ages ≥12 to ≤22 years
- Ability to perform spirometry
- Ability to follow instructions
Key exclusion criteria (2 listed)
- Use of respiratory support in the past 12 months
- Botulinum toxin injections within 12 months prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocolized breathing exercisesThe 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. | Behavioural | Intervention Arm |
| Sham Breathing ExercisesThe 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. | Behavioural | Control |
Primary outcome
Peak Expiratory Flow (PEF), Percentage of Predicted Value
Time frame: Measurements at baseline (week 0) , week 8.
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.
10 secondary outcomes
Peak Expiratory Flow (PEF), Percentage of Predicted Value
Time frame: Measurements at week 18
Peak Expiratory Flow (PEF), Liters per Second
Time frame: Measurements at baseline (week 0) , week 8, week 18
Forced Vital Capacity (FVC), Percentage of Predicted Value
Time frame: Measurements at baseline (week 0) , week 8, week 18
Forced Vital Capacity (FVC), Liters
Time frame: Baseline (week 0), week 8, and week 18
Forced Expiratory Volume in One Second (FEV1), Percentage of Predicted Value
Time frame: Baseline (week 0), week 8, and week 18
Forced Expiratory Volume in One Second (FEV1), Liters
Time frame: Baseline (week 0), week 8, and week 18
Quality of Life: Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen)
Time frame: Baseline (week 0), week 8, and week 18
Psychological Distress
Time frame: Baseline (week 0), week 8, and week 18
Eating and drinking abilities
Time frame: Measurements at baseline (week 0) , week 8, week 18
Severity and Frequency of Drooling
Time frame: Measurements at baseline (week 0) , week 8, week 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ibolya Túri, PhD principal investigator
Semmelweis Egyetem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolized breathing exercises in people with Cerebral Palsy, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibolya Túri, PhD. (+3612241500 ext. 1553, túri.ibolya@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Expiratory Flow (PEF), Percentage of Predicted Value (time frame: Measurements at baseline (week 0) , week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.