Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia (hernia)

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

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.

Study Overview

• Status: Completed
• Conditions: Hernias, Diaphragmatic, Congenital
• Intervention / Treatment: Other: chest resistance exercise; Other: chest expansion exercises

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al-Kharj, Riyadh, Saudi Arabia
      • King Khalid Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; 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.	Other: chest resistance exercise; lung function.; Other Names: respiratory muscle strength
Experimental: control group; 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	Other: chest expansion exercises; thoracic excursion; Other Names: POWER breath KH2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle Strength	evaluated by using POWER breathe KH2 equipment.	at baseline
Respiratory muscle Strength	evaluated by using POWER breathe KH2 equipment.	after 12 weeks
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thoracic excursion	assessed by tape measurement	at baseline
Thoracic excursion	assessed by tape measurement	after 12 weeks

Collaborators and Investigators

• Sponsor: Qassim University
• Collaborators: Cairo University; Prince Sattam Bin Abdulaziz University
• Investigators: Study Chair: Walid Kamal, PhD, Prince Sattam Bin Abdulaziz University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): April 5, 2021

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Hernia; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: RHPT/020/056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No