NCT06763406

Brief Summary

Research on exercise methods for pectus excavatum (PE) is limited, highlighting the need for further studies. This study investigated the effects of Schroth-based exercise therapy combined with vacuum treatment in 35 adolescents with PE, divided into a vacuum + exercise group (n=19) and a vacuum-only group (n=16). Outcomes included deformity severity, sagittal posture, thoracic cage and spinal mobility, muscle endurance, and quality of life. The combination therapy significantly improved sagittal spinal posture (craniovertebral, thoracic, thoracolumbar, lumbar angles) and deformity-specific quality of life (Nuss Questionnaire scores) compared to vacuum-only treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

December 4, 2024

Last Update Submit

January 6, 2025

Conditions

Pectus ExcavatumPectus Excavatum DeformityFunnel ChestChest Deformities

Keywords

Funnel chestPectus excavatumExerciseExercise therapyVacuumTissue expansion devices

Outcome Measures

Primary Outcomes (4)

  • Primary Outcome Measure 1: Deformity Severity

    Primary Outcome Measure 1: Deformity Severity Measurement: Anthropometric Index (cm) Details: Repeated, in cm. Time frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment

    12 weeks

  • Primary Outcome Measure 2: Sagittal Spinal Posture

    Primary Outcome Measure 2: Sagittal Spinal Posture Measurement: Lateral Photos (°) Details: In degrees Time Frame:The assessment will be conducted during the first week of treatment and 12 weeks after treatment

    12 weeks

  • Primary Outcome Measure 3: Disease-Specific QoL

    Primary Outcome Measure 3: Disease-Specific QoL Measurement: Nuss Questionnaire (1-4) Details: Higher = better Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment

    12 weeks

  • Primary Outcome Measure 4: General QoL

    Primary Outcome Measure 4: General QoL Measurement: PedsQL (0-100) Details: Higher = better Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment

    12 weeks

Secondary Outcomes (5)

  • Secondary Outcome Measure 1: Thoracic Cage Mobility

    12 weeks

  • Secondary Outcome Measure 2: Spinal Mobility

    12 weeks

  • Secondary Outcome Measure 3: Lumbar Mobility

    12 weeks

  • Secondary Outcome Measure 4: Muscle Endurance (Sit-Ups)

    12 weeks

  • Secondary Outcome Measure 5: Muscle Endurance (Lateral Bridge)

    12 weeks

Study Arms (2)

vacuum only

NO INTERVENTION

Vacuum plus exercise

EXPERIMENTAL
Other: Exercise

Interventions

ExerciseOTHER

Due to the limited research on exercise approaches for pectus excavatum, further investigation in this field is needed. This study aims to explore the impact of Schroth-based exercise therapy on adolescents with pectus excavatum.

Vacuum plus exercise

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • having pectus excavatum
  • being 10-18 years
  • having Haller index more than 2.5

You may not qualify if:

  • Individuals with pectus excavatum associated with a syndrome Individuals with mixed deformity
  • Individuals who have previously received any conservative treatment or surgery for chest deformity or spinal issues
  • Individuals with neuromuscular, rheumatic, or chronic systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Uuniversity

Ankara, altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Funnel ChestMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2024

First Posted

January 8, 2025

Study Start

April 15, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)