NCT07300748

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Dec 2025May 2026

First Submitted

Initial submission to the registry

November 13, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

December 9, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

November 13, 2025

Last Update Submit

February 25, 2026

Conditions

Keywords

pectus excavatumcardiopulmonary exercises

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

EXPERIMENTAL

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

pulmonary exercises group at home

ACTIVE COMPARATOR

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

Interventions

The physiotherapist will demonstrate the breathing and posture exercises to be performed at home.

pulmonary exercises group 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.

cardiopulmonary exercises group at hospital

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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)

RECRUITING

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ayşe Naz Kalem Özgen, specialist

CONTACT

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

Locations