Effectiveness of Cardiopulmonary Exercises for Children With Pectus Excavatum
The Effectiveness of Cardiopulmonary Exercise in Children With Pectus Excavatum: A Single-Blind, Randomised Controlled Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of this study is to investigate the effects of cardiopulmonary rehabilitation on respiratory function, exercise tolerance and posture in patients with pectus excavatum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2025
CompletedStudy Start
First participant enrolled
December 9, 2025
CompletedFirst Posted
Study publicly available on registry
December 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 9, 2026
February 27, 2026
February 1, 2026
5 months
November 13, 2025
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximal inspiration and expiration pressure
first day of exercises program and 5th week of exercises program
Secondary Outcomes (10)
6 minute walking test
first day of exercises program and 5th week of exercises program
New York Posture Scale
first day of exercises program and 5th week of exercises program
Measurement of chest expansion in centimetres using a tape measure
first day of exercises program and 5th week of exercises program
Assessment of symptoms (exercise intolerance, psychological impact, resting dyspnoea, chest pain, spinal pain, gastrointestinal symptoms, palpitations, dyspnoea) using a visual analogue scale
first day of exercises program and 5th week of exercises program
Cobb angle analysis using the Diers Formatrix 4D device (Wiesbaden, Germany)
first day of exercises program and 5th week of exercises program
- +5 more secondary outcomes
Study Arms (2)
cardiopulmonary exercises group at hospital
EXPERIMENTALThe working group will be provided with a personalised exercise plan by a physiotherapist specialising in that field at the cardiopulmonary rehabilitation unit, to be carried out twice a week for five weeks. Patients will work on a bicycle ergometer. In addition, the same physiotherapist will demonstrate breathing and posture exercises for patients to perform at home.
pulmonary exercises group at home
ACTIVE COMPARATORThe physiotherapist will only demonstrate the breathing and posture exercises that patients in the control group will perform at home.
Interventions
The physiotherapist will demonstrate the breathing and posture exercises to be performed at home.
Patients will exercise using a bicycle ergometer. In addition, the same physiotherapist will demonstrate breathing and posture exercises for them to perform at home.
Eligibility Criteria
You may qualify if:
- Children aged 5-18 years with pectus excavatum deformity
- Children undergoing conservative treatment (vacuum orthosis, exercise)
- Patients whose families have signed a consent form agreeing to participate in the study
You may not qualify if:
- Known cardiac disease
- Presence of an additional syndrome (Marfan syndrome, etc.)
- Cobb angle ≥10°
- Refusal to participate in the study
- Presence of mixed deformity (pectus arcuatum)
- Those with an indication for surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PM&R Specialist
Study Record Dates
First Submitted
November 13, 2025
First Posted
December 24, 2025
Study Start
December 9, 2025
Primary Completion (Estimated)
May 9, 2026
Study Completion (Estimated)
May 9, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02