Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia

Not Applicable

Completed

• Conditions: Hernias, Diaphragmatic, Congenital

• Registration Number: NCT04900649
• Lead Sponsor: Qassim University

Brief Summary

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.

Detailed Description

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 .

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2021-02-20
• Study Completion: 2021-04-05
• Status Verified: 2021-05
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory muscle Strength	after 12 weeks	evaluated by using POWER breathe KH2 equipment.
Lung functions	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 Outcome Measures

Name	Time	Method
Thoracic excursion	after 12 weeks	assessed by tape measurement

Trial Locations

Locations (1)

King Khalid Hospital; 🇸🇦 Al-Kharj, Riyadh, Saudi Arabia