Clinical trial NCT04900649: Resistance Exercise in Children With Post-operative Congenital Diaphragmatic 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernias, Diaphragmatic, Congenital
Lead sponsor: Qassim University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Prince Sattam Bin Abdulaziz University
First posted: 2021-05-25
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory muscle Strength
timeFrame: at baseline
measure: Respiratory muscle Strength
timeFrame: after 12 weeks
measure: Lung functions
timeFrame: at baseline
measure: Lung functions
timeFrame: after 12 weeks
Secondary outcomes:
measure: Thoracic excursion
timeFrame: at baseline
measure: Thoracic excursion
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Al-Kharj
country: Saudi Arabia
facility: King Khalid Hospital
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Walid Kamal, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Alshimaa Azab, PhD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1002/ajmg.c.30133. No abstract available.
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):668-74; discussion 668-74. doi: 10.1016/j.jpedsurg.2005.12.007.
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.