Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia

NCT04900649 | Completed

• 1 other identifier: RHPT/020/056
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernias, Diaphragmatic, Congenital

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Thoracic excursion

  at baseline

• Thoracic excursion

  after 12 weeks

Study Arms (2)

study group

EXPERIMENTAL

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

control group

EXPERIMENTAL

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

Interventions

chest resistance exercise OTHER

lung function.

Also known as: respiratory muscle strength

study group

chest expansion exercises OTHER

thoracic excursion

Also known as: POWER breath KH2

control group

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• physical disability.
• diaphragmatic eventration.
• unable to perform all tests or procedures.
• children with cardiac anomalies

Sponsors & Collaborators

• Qassim University: lead
• Cairo University: collaborator
• Prince Sattam Bin Abdulaziz University: collaborator

Study Sites (1)

King Khalid Hospital

Al Kharj, Riyadh Region, Saudi Arabia

Location

Related 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. doi: 10.1002/ajmg.c.30133. No abstract available.

  PMID: 17436306 BACKGROUND

• 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.

  PMID: 16567174 RESULT

• 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.

  PMID: 19961637 RESULT

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Walid Kamal, PhD

  Prince Sattam Bin Abdulaziz University

  STUDY CHAIR

• Alshimaa Azab, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: May 1, 2020
• Primary Completion: February 20, 2021
• Study Completion: April 5, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

SA (1)