EFFECT OF ARM ERGOMETRY ON RESPIRATIONNCT05068570
Effect of Arm Ergometry on Children With Down Syndrome
A study testing ARMEROMTERY in people with EFFECT OF ARM ERGOMETRY ON RESPIRATION, run by Badr University at 1 site in Egypt.
Trial summary
Cardiopulmonary issues are the major cause of sickness and hospitalisation in children with Down syndrome . Down syndrome children are also more likely to develop chronic lung infections, middle ear infections, and persistent tonsillitis. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- EFFECT OF ARM ERGOMETRY ON RESPIRATION
- What is being tested?
- ARMEROMTERY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Sep 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
- comprehend and follow directions
- AGE 10-14
Who cannot join
- Anomalies of the vasculature.
- -Participating in sports of any kind. Moderate to severe asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Arm Ergometry Training on Pulmonary Function in Children With Down Syndrome
Cardiopulmonary issues are the major cause of sickness and hospitalisation in children with Down syndrome . Down syndrome children are also more likely to develop chronic lung infections, middle ear infections, and persistent tonsillitis.
Read the detailed description
30 Down's syndrome children (boys and girls). randomly separated into two groups of equal size. Both groups received traditional chest physical therapy, with the addition of arm ergometry training in Group B
- Conditions
- EFFECT OF ARM ERGOMETRY ON RESPIRATION
- Being tested
- ARMEROMTERY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARMEROMTERYOther
ARMERGOMTERY TRAINING FOR UPPERLIMB
| Study group | Role | What they receive |
|---|---|---|
| EXPERMINTAL GROUP | Experimental | start with cycle at a pace of 15-25 cycles per minute without resistance and end with cycle 45cycles per minute Receives: Other: ARMEROMTERY |
| CONTROL GROUP | No intervention | selected respiratory exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discovery Spirometer
measure forced expiratory volume, the means incresed mean improvement
Measured: pre and post treatment for 14 weeks at 3 times per week.
Discovery spirometer
Measure peak volume,the means incresed mean improvement
Measured: Pre and post treatment for 14 weeks at 3 times per week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Jun 2021
- Primary completion10 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EFFECT OF ARM ERGOMETRY ON RESPIRATIONStudies 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanaa mohsen, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068570
- Sponsor's protocol ID
- HANAA 8
- Status last verified
- Feb 2022
- First submitted
- 7 Sep 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Arm Ergometry Training on Pulmonary Function in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05068570
- Acronym / sponsor ID
- HANAA 8
- Conditions
- EFFECT OF ARM ERGOMETRY ON RESPIRATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 6 Oct 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.
Cardiopulmonary issues are the major cause of sickness and hospitalisation in children with Down syndrome . Down syndrome children are also more likely to develop chronic lung infections, middle ear infections, and persistent tonsillitis.
Detailed description
30 Down's syndrome children (boys and girls). randomly separated into two groups of equal size. Both groups received traditional chest physical therapy, with the addition of arm ergometry training in Group B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERMINTAL GROUP | Experimental | Other: ARMEROMTERYstart with cycle at a pace of 15-25 cycles per minute without resistance and end with cycle 45cycles per minute |
| CONTROL GROUP | No intervention | –selected respiratory exercise program |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- comprehend and follow directions
- AGE 10-14
Key exclusion criteria (2 listed)
- Anomalies of the vasculature.
- -Participating in sports of any kind. Moderate to severe asthma
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 |
|---|---|---|
| ARMEROMTERYARMERGOMTERY TRAINING FOR UPPERLIMB | Other | EXPERMINTAL GROUP |
Primary outcome
Discovery Spirometer
Time frame: pre and post treatment for 14 weeks at 3 times per week.
measure forced expiratory volume, the means incresed mean improvement
Discovery spirometer
Time frame: Pre and post treatment for 14 weeks at 3 times per week
Measure peak volume,the means incresed mean improvement
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 15 Feb 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARMEROMTERY in people with EFFECT OF ARM ERGOMETRY ON RESPIRATION, run by Badr University at 1 site in Egypt.
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 2 inclusion and 2 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 15 Feb 2022. 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 Egypt. 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?
Discovery Spirometer (time frame: pre and post treatment for 14 weeks at 3 times per week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2022.