Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia

NCT ID: NCT04900649

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-04-05

Brief Summary

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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

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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 .

Conditions

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Hernias, Diaphragmatic, Congenital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

chest resistance exercise

Intervention Type OTHER

lung function.

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

Group Type EXPERIMENTAL

chest expansion exercises

Intervention Type OTHER

thoracic excursion

Interventions

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chest resistance exercise

lung function.

Intervention Type OTHER

chest expansion exercises

thoracic excursion

Intervention Type OTHER

Other Intervention Names

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respiratory muscle strength POWER breath KH2

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role collaborator

Qassim University

OTHER

Sponsor Role lead

Responsible Party

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Maged Basha

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.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walid Kamal, PhD

Role: STUDY_CHAIR

Prince Sattam Bin Abdulaziz University

Alshimaa Azab, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

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King Khalid Hospital

Al Kharj, Riyadh Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 17436306 (View on PubMed)

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.

Reference Type RESULT
PMID: 16567174 (View on PubMed)

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.

Reference Type RESULT
PMID: 19961637 (View on PubMed)

Other Identifiers

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RHPT/020/056

Identifier Type: -

Identifier Source: org_study_id

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