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Completed

NCT Number: NCT04900649

Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia

Congenital diaphragmatic hernia (CDH) is a life-threatening condition with long-term complications including respiratory tract infections, respiratory muscle weakness, and abnormal lung functions. This study, therefore, has been designed to ascertain the effect of chest resistance exercise and chest expansion exercise on respiratory muscle strength, lung function, and chest mobility in children with post-operative CDH.

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Key information

Conditions

Hernias, Diaphragmatic, Congenital Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Khalid Hospital

Al Kharj, Riyadh Region, Saudi Arabia

About this study

With the advances in surgical and neonatal treatment, the survival rates in children with CDH have been improved in the last decades. The surviving children may suffer from long-term complications such as impairments in lung growth (lung hypoplasia), cardiovascular disorders, pulmonary hypertension, gastrointestinal problems, and recurrent occurrence of lower respiratory tract infection. One of the physical therapy techniques used to treat chest disorders via encouraging the normal alignment of respiratory muscles with respiratory rhythm is chest resistance exercise through applying resistance to the sternal and coastal areas .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ages between 10 and 14 years.
  • the BMI between 20 and 25 Kg/m2. the children were considered as high risky CDH as they developed respiratory distress in the first days of their life.
  • CDH was corrected surgically immediately after birth.
  • children are still in following upstate in pediatric and physical therapy departments.

Exclusion criteria

  • physical disability.
  • diaphragmatic eventration.
  • unable to perform all tests or procedures.
  • children with cardiac anomalies

Treatment and study plan

chest resistance exercise

Other

lung function.

Other names: respiratory muscle strength

Chest Expansion Exercises

Other

thoracic excursion

Other names: POWER breath KH2

Primary outcomes

  1. Respiratory muscle Strength

    Time frame: at baseline

    evaluated by using POWER breathe KH2 equipment.

  2. Respiratory muscle Strength

    Time frame: after 12 weeks

    evaluated by using POWER breathe KH2 equipment.

  3. Lung functions

    Time frame: at baseline

    assessed by the Minispir® Light spirometer with Winspiro® Light software. The child was seated with knees flexed 90° and was asked to hold three deep breaths, take deep inspiration to total lung capacity (TLC), then expire all the air inside the lungs to their residual volume (RV) to obtain the variables FEV1 (forced expiratory volume in 1 s) and FVC (forced vital capacity).

  4. Lung functions

    Time frame: after 12 weeks

    assessed by the Minispir® Light spirometer with Winspiro® Light software. The child was seated with knees flexed 90° and was asked to hold three deep breaths, take deep inspiration to total lung capacity (TLC), then expire all the air inside the lungs to their residual volume (RV) to obtain the variables FEV1 (forced expiratory volume in 1 s) and FVC (forced vital capacity).

Secondary outcomes

  1. Thoracic excursion

    Time frame: at baseline

    assessed by tape measurement

  2. Thoracic excursion

    Time frame: after 12 weeks

    assessed by tape measurement

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Collaborators

  • Cairo University
  • Prince Sattam Bin Abdulaziz University

Registry information

Official study title

Effect of Chest Resistance Exercise Combined With Chest Expansion Exercises on Respiratory Muscle Strength, Lung Function, and Thoracic Excursion in Children With Post-operative Congenital Diaphragmatic Hernia

Acronym: hernia

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 25, 2021
Registry last updated
May 25, 2021

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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