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

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 Overview

• Status: Recruiting
• Conditions: Pectus Excavatum Deformity
• Intervention / Treatment: Other: Cardiopulmonary exercises at hospital; Other: Pulmonary and posture exercises at home

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayse Naz Kalem Ozgen, Specialist; Phone Number: +90 0312 797 00 00; Email: kalemnaz@gmail.com

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06010
      • Recruiting
      • Ankara Etlik City Hospital
      • Contact: Ayşe Naz Kalem Özgen; Phone Number: +90 0312 797 00 00; Email: kalemnaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children aged 5-18 years with pectus excavatum deformity
2. Children undergoing conservative treatment (vacuum orthosis, exercise)
3. Patients whose families have signed a consent form agreeing to participate in the study

Exclusion Criteria:

1. Known cardiac disease
2. Presence of an additional syndrome (Marfan syndrome, etc.)
3. Cobb angle ≥10°
4. Refusal to participate in the study
5. Presence of mixed deformity (pectus arcuatum)
6. Those with an indication for surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cardiopulmonary exercises group at hospital; The 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.	Other: Cardiopulmonary exercises at hospital; Patients will exercise using a bicycle ergometer. In addition, the same physiotherapist will demonstrate breathing and posture exercises for them to perform at home.
Active Comparator: pulmonary exercises group at home; The physiotherapist will only demonstrate the breathing and posture exercises that patients in the control group will perform at home.	Other: Pulmonary and posture exercises at home; The physiotherapist will demonstrate the breathing and posture exercises to be performed at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal inspiration and expiration pressure	first day of exercises program and 5th week of exercises program

Secondary Outcome Measures

Outcome Measure	Time Frame
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
body lenght	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

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): May 9, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pectus excavatum; cardiopulmonary exercises
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Funnel Chest
• Other Study ID Numbers: AEŞH-EK-2025-168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No