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Pilot Study on Breathing Exercises and Pulmonary Function in Children With Cerebral Palsy: A Randomized Trial 55 Randomized Pediatric Exercise-Based

Active, not recruiting
Clinical Trial NCT06840626 is an interventional study for Cerebral Palsy that is active, not recruiting. It started on April 15, 2024 with plans to enroll 55 participants. Led by Semmelweis University, it is expected to complete by March 30, 2025. The latest data from ClinicalTrials.gov was last updated on February 21, 2025.
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 str...Show More
Official Title

Pilot Study on the Effects of Conductive Breathing Exercises on Pulmonary Function in School-Aged Children With Cerebral Palsy: A Randomized Controlled Trial

Conditions
Cerebral Palsy
Other Study IDs
  • SE11568780
NCT ID Number
NCT06840626
Start Date (Actual)
2024-04-15
Last Update Posted
2025-02-21
Completion Date (Estimated)
2025-03-30
Enrollment (Estimated)
55
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
cerebral palsy
respiratory health
spirometry
CP quality of life
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention 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 rehabili...Show More
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...Show More
No InterventionControl 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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Cerebral Palsy Quality of Life
The CP QoL test measures changes in quality of life (QoL) across different domains, such as social and emotional well-being, acceptance, bodily pain, and functioning. The assessment is conducted at three time points: 0 weeks, 8 weeks, and 18 weeks. Scoring and Interpretation: Scale: Scores are recorded from 1 to 9, where 1 = Very unhappy and 9 = Very happy. Higher scores indicate better quality of life (QoL).
measurement at 0 weeks, 8 weeks, 18 weeks
Severity and Frequency of Drooling
The severity and frequency of drooling will be assessed for changes.
measurement at 0 weeks, 8 weeks, 18 weeks
Depression level
Depression Scale (DAS-D): Measures symptoms of depression such as low mood, hopelessness, and loss of interest. • Scale Details: * Minimum Score: \[0\] * Maximum Score: \[28\] In this scale, higher scores represent worse outcomes (indicating more severe depression symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of depression).
measurement at 0 weeks, 8 weeks, 18 weeks
Anxiety level
Anxiety Scale (DAS-A): Assesses symptoms related to anxiety, including nervousness, panic, and fear. Scale Details: * Minimum Score: \[0\] * Maximum Score: \[20\] In this scale, higher scores represent worse outcomes (indicating more severe anxiety symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of anxiety).
measurement at 0 weeks, 8 weeks, 18 weeks
Stress level
Stress Scale (DAS-S): Evaluates stress-related symptoms like irritability, tension, and difficulty relaxing. Scale Details: * Minimum Score: \[0\] * Maximum Score: \[34\] In this scale, higher scores represent worse outcomes (indicating more severe stress symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of stress).
measurement at 0 weeks, 8 weeks, 18 weeks
Eating Ability
Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids.
measurement at 0 weeks, 8 weeks, 18 weeks
Drinking Ability
Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids.
measurement at 0 weeks, 8 weeks, 18 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
12 Years
Eligible Sexes
All
Eligibility 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

  • Children who have received recent surgical procedures or botulinum toxin injections
  • Children who are unable to perform spirometry
Semmelweis University logoSemmelweis University
Center for Translational Medicine logoCenter for Translational Medicine
No contact data.
1 Study Locations in 1 Countries

Pest County

Semmelweis University, Conductive Pedagogical Methodology Institution and College., Budapest, Pest County, 1125, Hungary