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

NCT06840626 | Active Not Recruiting

• 1 other identifier: SE11568780
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Keywords

cerebral palsy; respiratory health; spirometry; CP quality of life

Outcome Measures

Primary Outcomes (7)

• Forced Expiratory Volume in 1st second (FEV1) in (L)

  Change from baseline in forced expiratory volume in 1st second (FEV1) * Description: FEV1 is the maximal volume of air that can be expired in the first second of forced vital capacity maneuver using spirometry. * Units of Measure: L (Liter)

  • Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks

• Forced Expiratory Volume in 1st second (FEV1) in %

  Change from baseline in forced expiratory volume in 1st second (FEV1) • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards.

  Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks

• Forced Vital Capacity (FVC) in (L)

  * Description: FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry. * Units of Measure: L (Liter)

  Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks

• Forced Vital Capacity (FVC) in %

  FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry. • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards:

  Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks

• FEV1/FVC Ratio

  Description: This is already a combined measurement (a ratio of Forced Expiratory Volume in the first second to Forced Vital Capacity). No unit.

  Measured at 0, 8, and 18 weeks.

• Peak Expiratory Flow (PEF) in (L/sec)

  Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry. Units of Measure: L/sec (Liter/secundum)

  Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks

• Peak Expiratory Flow (PEF) in %

  Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry. • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards.

  Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks

Secondary Outcomes (7)

• Cerebral Palsy Quality of Life

  measurement at 0 weeks, 8 weeks, 18 weeks

• Severity and Frequency of Drooling

  measurement at 0 weeks, 8 weeks, 18 weeks

• Depression level

  measurement at 0 weeks, 8 weeks, 18 weeks

• Anxiety level

  measurement at 0 weeks, 8 weeks, 18 weeks

• Stress level

  measurement at 0 weeks, 8 weeks, 18 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Other: Series of breathing exercises

Control Arm

NO INTERVENTION

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.

Interventions

Series of breathing exercises 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.

Intervention Arm

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Semmelweis University: lead
• Center for Translational Medicine: collaborator

Study Sites (1)

Semmelweis University, Conductive Pedagogical Methodology Institution and College.

Budapest, Pest County, 1125, Hungary

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study employs double-blinded, whereby participants are unaware of their assigned treatment, and professionals are also unaware of whether they belong to the control or intervention group. The school-age children with CP in the study could only be randomised on the basis of class membership. The classes were separated, and the professionals involved were unaware of which group was assigned to the intervention or control. The professionals in the control group were provided with a breathing protocol that incorporated sham breathing tasks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 21, 2025
• Study Start: April 15, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)