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NCT Number: NCT06763406

The Effects of Schroth Based Exercise Therapy in Adolescents with Pectus Excavatum

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.

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Key information

Conditions

Pectus Excavatum Behavior Bone Diseases Bone Diseases, Developmental Chest Deformities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Motor Activity Musculoskeletal Abnormalities Musculoskeletal Diseases Pectus Excavatum Deformity

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe Uuniversity

Ankara, altındağ, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Exercise

Other

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.

Primary outcomes

  1. Primary Outcome Measure 1: Deformity Severity

    Time frame: 12 weeks

    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

  2. Primary Outcome Measure 2: Sagittal Spinal Posture

    Time frame: 12 weeks

    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

  3. Primary Outcome Measure 3: Disease-Specific QoL

    Time frame: 12 weeks

    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

  4. Primary Outcome Measure 4: General QoL

    Time frame: 12 weeks

    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

Secondary outcomes

  1. Secondary Outcome Measure 1: Thoracic Cage Mobility

    Time frame: 12 weeks

    Secondary Outcome Measure 1: Thoracic Cage Mobility Measurement: Chest Circumference (cm) Details: In cm Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment

  2. Secondary Outcome Measure 2: Spinal Mobility

    Time frame: 12 weeks

    Secondary Outcome Measure 2: Spinal Mobility Measurement: Sit-and-Reach (cm) Details: Highest value Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment

  3. Secondary Outcome Measure 3: Lumbar Mobility

    Time frame: 12 weeks

    Secondary Outcome Measure 3: Lumbar Mobility - Measurement: Modified Schober (cm) Details: Difference in cm Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment

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

    Time frame: 12 weeks

    Secondary Outcome Measure 4: Muscle Endurance (Sit-Ups) Measurement: Sit-Up (reps/30s) Details: Repetitions Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment

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

    Time frame: 12 weeks

    Secondary Outcome Measure 5: Muscle Endurance (Lateral Bridge) Measurement: Lateral Bridge (s) Details: Duration Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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