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

Primary Purpose

Hernias, Diaphragmatic, Congenital

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
chest resistance exercise
chest expansion exercises
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernias, Diaphragmatic, Congenital

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Khalid Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Respiratory muscle Strength
evaluated by using POWER breathe KH2 equipment.
Respiratory muscle Strength
evaluated by using POWER breathe KH2 equipment.
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).
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).

Secondary Outcome Measures

Thoracic excursion
assessed by tape measurement
Thoracic excursion
assessed by tape measurement

Full Information

First Posted
May 19, 2021
Last Updated
May 21, 2021
Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT04900649
Brief Title
Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia
Acronym
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
April 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernias, Diaphragmatic, Congenital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
chest resistance exercise
Other Intervention Name(s)
respiratory muscle strength
Intervention Description
lung function.
Intervention Type
Other
Intervention Name(s)
chest expansion exercises
Other Intervention Name(s)
POWER breath KH2
Intervention Description
thoracic excursion
Primary Outcome Measure Information:
Title
Respiratory muscle Strength
Description
evaluated by using POWER breathe KH2 equipment.
Time Frame
at baseline
Title
Respiratory muscle Strength
Description
evaluated by using POWER breathe KH2 equipment.
Time Frame
after 12 weeks
Title
Lung functions
Description
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).
Time Frame
at baseline
Title
Lung functions
Description
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).
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Thoracic excursion
Description
assessed by tape measurement
Time Frame
at baseline
Title
Thoracic excursion
Description
assessed by tape measurement
Time Frame
after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid Kamal, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alshimaa Azab, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
King Khalid Hospital
City
Al-Kharj
State/Province
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
17436306
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.
Results Reference
background
PubMed Identifier
16567174
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.
Results Reference
result
PubMed Identifier
19961637
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.
Results Reference
result

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Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia

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