NCT07300748
Recruiting
Not Applicable
The Effectiveness of Cardiopulmonary Exercise in Children With Pectus Excavatum: A Single-Blind, Randomised Controlled Trial
Ankara Etlik City Hospital1 site in 1 country40 target enrollmentStarted: October 9, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ankara Etlik City Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Maximal inspiration and expiration pressure
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Maximal inspiration and expiration pressure
Time Frame: first day of exercises program and 5th week of exercises program
Secondary Outcomes
- body lenght(first day of exercises program and 5th week of exercises program)
- 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)
- Thoracic kyphosis angle(first day of exercises program and 5th week of exercises program)
- Saggital balance angle using the Diers Formatrix 4D device (Wiesbaden, Germany)(first day of exercises program and 5th week of exercises program)
- Coronal balance angle using the Diers Formatrix 4D device (Wiesbaden, Germany)(first day of exercises program and 5th week of exercises program)
- pelvic obliquity angle using the Diers Formatrix 4D device (Wiesbaden, Germany)(first day of exercises program and 5th week of exercises program)
Investigators
Ayse Naz Kalem
PM&R Specialist
Ankara Etlik City Hospital
Study Sites (1)
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