Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia

Not Applicable

Completed

• Conditions: Hernias, Diaphragmatic, Congenital
• Interventions: Other: chest expansion exercises; Other: chest resistance exercise

• 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

Arm && Interventions

Group	Intervention	Description
control group	chest expansion exercises	12-week usual chest physiotherapy in form of bilateral vibration and gentle percussion for 3-5 minutes with distal finger phalanges to the upper apical lobes in modified drainage positions, placing the patient in a side-lying position or a prone position to increase oxygenation, at least 2-3 times a week
study group	chest resistance exercise	the study group has conducted chest resisted exercise combined with chest expansion exercise in addition to a usual chest physiotherapy. For chest resistance exercise, the children in the study group underwent sequential 12-week chest resistance exercise and chest expansion exercise, three sessions a week. Chest resistance exercises have been consisted of manual resistance exercise and resistance exercise via POWER breath KH2.

Primary Outcome Measures

Name	Time	Method
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).
Respiratory muscle Strength	after 12 weeks	evaluated by using POWER breathe KH2 equipment.

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