Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia

Hernias, Diaphragmatic, Congenital Clinical Trial

— hernia  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04900649
• Other study ID #: RHPT/020/056
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: May 2021
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 5, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Intervention

Other:
• chest resistance exercise
lung function.
• chest expansion exercises
thoracic excursion

Locations

Country	Name	City	State
Saudi Arabia	King Khalid Hospital	Al-Kharj	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
Qassim University	Cairo University, Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

Ackerman KG, Pober BR. Congenital diaphragmatic hernia and pulmonary hypoplasia: new insights from developmental biology and genetics. Am J Med Genet C Semin Med Genet. 2007 May 15;145C(2):105-8. Review. — View Citation

Lally KP, Bagolan P, Hosie S, Lally PA, Stewart M, Cotten CM, Van Meurs KP, Alexander G; Congenital Diaphragmatic Hernia Study Group. Corticosteroids for fetuses with congenital diaphragmatic hernia: can we show benefit? J Pediatr Surg. 2006 Apr;41(4):668 — View Citation

Malaguti C, Rondelli RR, de Souza LM, Domingues M, Dal Corso S. Reliability of chest wall mobility and its correlation with pulmonary function in patients with chronic obstructive pulmonary disease. Respir Care. 2009 Dec;54(12):1703-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle Strength	evaluated by using POWER breathe KH2 equipment.	at baseline
Primary	Respiratory muscle Strength	evaluated by using POWER breathe KH2 equipment.	after 12 weeks
Primary	Lung functions	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).	at baseline
Primary	Lung functions	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).	after 12 weeks
Secondary	Thoracic excursion	assessed by tape measurement	at baseline
Secondary	Thoracic excursion	assessed by tape measurement	after 12 weeks