Hernias, Diaphragmatic, CongenitalherniaNCT04900649
Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia
A study testing chest resistance exercise and chest expansion exercises in people with Hernias, Diaphragmatic, Congenital, run by Qassim University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Hernias, Diaphragmatic, Congenital
- What is being tested?
- chest resistance exercise and chest expansion exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2020to 5 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- physical disability.
- diaphragmatic eventration.
- unable to perform all tests or procedures.
- children with cardiac anomalies
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 .
- Conditions
- Hernias, Diaphragmatic, Congenital
- Being tested
- chest resistance exercise, chest expansion exercises
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest resistance exerciseOther
Also called respiratory muscle strength
lung function.
chest expansion exercisesOther
Also called POWER breath KH2
thoracic excursion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: chest expansion exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle Strength
evaluated by using POWER breathe KH2 equipment.
Measured: at baseline
Respiratory muscle Strength
evaluated by using POWER breathe KH2 equipment.
Measured: 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).
Measured: 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).
Measured: after 12 weeks
Secondary outcomes (2)
Thoracic excursion
assessed by tape measurement
Measured: at baseline
Thoracic excursion
assessed by tape measurement
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 May 2020
- Primary completion20 Feb 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hernias, Diaphragmatic, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Walid Kamal, PhD, Study chair, Prince Sattam Bin Abdulaziz UniversityAlshimaa Azab, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900649
- Sponsor's protocol ID
- RHPT/020/056
- Acronym
- hernia
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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.
PubMed 17436306Lally 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.
PubMed 16567174Malaguti 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.
PubMed 19961637
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04900649
- Acronym / sponsor ID
- hernia / RHPT/020/056
- Conditions
- Hernias, Diaphragmatic, Congenital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Study start
- 1 May 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: chest resistance exercisethe 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. |
| control group | Experimental | Other: chest expansion exercises12-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 |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- physical disability.
- diaphragmatic eventration.
- unable to perform all tests or procedures.
- children with cardiac anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest resistance exerciseAlso: respiratory muscle strengthlung function. | Other | study group |
| chest expansion exercisesAlso: POWER breath KH2thoracic excursion | Other | control group |
Primary outcome
Respiratory muscle Strength
Time frame: at baseline
evaluated by using POWER breathe KH2 equipment.
Respiratory muscle Strength
Time frame: after 12 weeks
evaluated by using POWER breathe KH2 equipment.
Lung functions
Time frame: at baseline
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
Time frame: after 12 weeks
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).
2 secondary outcomes
Thoracic excursion
Time frame: at baseline
Thoracic excursion
Time frame: after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Background: PubMed 17436306Ackerman 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 publication: PubMed 16567174Lally 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 publication: PubMed 19961637Malaguti 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.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Related trials for Hernias, Diaphragmatic, Congenital
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Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
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Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
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Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walid Kamal, PhD study chair
Prince Sattam Bin Abdulaziz University
Alshimaa Azab, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest resistance exercise and chest expansion exercises in people with Hernias, Diaphragmatic, Congenital, run by Qassim University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle Strength (time frame: at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900649, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.