Pulmonary FunctionsNCT04787861
Motorized Movement Therapy & Pulmonary Functions in Down Syndrome
A study testing motorized movement therapy in people with Pulmonary Functions and Down Syndrome, run by Taibah University at 1 site in Saudi Arabia.
Trial summary
To investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with Down Syndrome Read more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- Pulmonary Functions, Down Syndrome
- What is being tested?
- motorized movement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Dec 2018to 4 May 2020
- 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 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ability to walk independently
- No involvement in any physical rehabilitation program or sports activity
- Ability to understand and follow orders
Who cannot join
- Children suffering from obesity
- Severe visual and/or auditory impairment
- Congenital heart disease
- Children with musculoskeletal disorders
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Medical Rehabilitation Hospital
Al Madīnah, Al Madinah Al Munawarah
About this study
Official title: Improved Pulmonary Functions and Exercise Capacity in Children With Down Syndrome Following Motorized Movement Therapy: Comparison With Chest Physical Therapy
To investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with Down Syndrome
Read the detailed description
To investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with Down Syndrome (DS). Methods: This randomized controlled study included 40 children (24 boys \& 16 girls) with DS. Their ages ranged from 9 to 13 years. The control group received conventional chest physical therapy program, three sessions per week for 12 weeks. The study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group. Pulmonary function tests, and six-minutes walking test were measured at baseline, after 18 sessions and after 36 sessions of treatment.
- Conditions
- Pulmonary Functions, Down Syndrome
- Being tested
- motorized movement therapy
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motorized movement therapyOther
The study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Control group treatment is identical to treatment of the study group but without a motorized movement device.Childen in this group received chest physical therapy program including positioning, breathing exercises, and postural drainage in addition to incentive spirometer training for 20 minutes, 3 times/week for 12 weeks. Receives: Other: motorized movement therapy |
| study group | Experimental | This group received the same program given to the control group in addition to an aerobic training regimen for 25 minutes 3 times/week for 12 weeks using a motorized movement device. Receives: Other: motorized movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in forced expiratory volume in 1st second (FEV1)
FEV1 is the maximal volume of air that can be expired in 1st second of forced vital capacity maneuver using spirometry. We measured FEV1 at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
Measured: Baseline, week 6 and week 12
Change from baseline in forced vital capacity (FVC)
Forced vital capacity (FVC) is the maximal volume of air that can be expired while patient performs forced expiration as fast and as deep as possible using spirometry.
We measured FVC at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
Measured: Baseline, week 6 and week 12
Change from baseline in FEV1/FVC ratio
FEV1/FVC is used to differentiate obstructive from restrictive patterns by spirometry. We measuredFEV1/ FVC at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
Measured: Baseline, week 6 and week 12
Change from baseline in peak expiratory flow rate (PEFR).
Peak expiratory flow rate (PEFR).is the maximal flow rate achieved during FVC maneuver using spirometry.
We measured PEFR at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
Measured: Baseline, week 6 and week 12
Change from baseline in maximum voluntary ventilation (MVV)
maximum voluntary ventilation (MVV) is the maximal volume of air that can be moved by voluntary ventilation in 1 minute while the patient breathes deeply and rapidly for 12 to 15 seconds using spirometry.
We measured MVV at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
Measured: Baseline, week 6 and week 12
Secondary outcomes (1)
Six-minutes walking test
The distance covered during of 6 minutes
Measured: Week 1,6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start17 Dec 2018
- Primary completion7 Mar 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FunctionsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taibah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatem Abd Elmohsen Abdel Hamid Emara, Taibah University
- Investigators
- Hatem A Emara, A.Prof, Principal investigator, Taibah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787861
- Sponsor's protocol ID
- Down Syndrome
- Status last verified
- Mar 2021
- First submitted
- 12 Feb 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoshimi K, Ueki J, Seyama K, Takizawa M, Yamaguchi S, Kitahara E, Fukazawa S, Takahama Y, Ichikawa M, Takahashi K, Fukuchi Y. Pulmonary rehabilitation program including respiratory conditioning for chronic obstructive pulmonary disease (COPD): Improved hyperinflation and expiratory flow during tidal breathing. J Thorac Dis. 2012 Jun 1;4(3):259-64. doi: 10.3978/j.issn.2072-1439.2012.03.17.
PubMed 22754664Pehlivan E, Niksarlioglu EY, Balci A, Kilic L. The Effect of Pulmonary Rehabilitation on the Physical Activity Level and General Clinical Status of Patients with Bronchiectasis. Turk Thorac J. 2019 Jan 1;20(1):30-35. doi: 10.5152/TurkThoracJ.2018.18093.
PubMed 30664424
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Pulmonary Functions and Exercise Capacity in Children With Down Syndrome Following Motorized Movement Therapy: Comparison With Chest Physical Therapy
- ClinicalTrials.gov ID
- NCT04787861
- Acronym / sponsor ID
- Down Syndrome
- Conditions
- Pulmonary Functions, Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taibah UniversityUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 7 Mar 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 9 Mar 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.
To investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with Down Syndrome
Detailed description
To investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with Down Syndrome (DS). Methods: This randomized controlled study included 40 children (24 boys \& 16 girls) with DS. Their ages ranged from 9 to 13 years. The control group received conventional chest physical therapy program, three sessions per week for 12 weeks. The study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group. Pulmonary function tests, and six-minutes walking test were measured at baseline, after 18 sessions and after 36 sessions of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: motorized movement therapyControl group treatment is identical to treatment of the study group but without a motorized movement device.Childen in this group received chest physical therapy program including positioning, breathing exercises, and postural drainage in addition to incentive spirometer training for 20 minutes, 3 times/week for 12 weeks. |
| study group | Experimental | Other: motorized movement therapyThis group received the same program given to the control group in addition to an aerobic training regimen for 25 minutes 3 times/week for 12 weeks using a motorized movement device. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ability to walk independently
- No involvement in any physical rehabilitation program or sports activity
- Ability to understand and follow orders
Key exclusion criteria (4 listed)
- Children suffering from obesity
- Severe visual and/or auditory impairment
- Congenital heart disease
- Children with musculoskeletal disorders
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 |
|---|---|---|
| motorized movement therapyThe study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group. | Other | Control group, study group |
Primary outcome
Change from baseline in forced expiratory volume in 1st second (FEV1)
Time frame: Baseline, week 6 and week 12
FEV1 is the maximal volume of air that can be expired in 1st second of forced vital capacity maneuver using spirometry. We measured FEV1 at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
Change from baseline in forced vital capacity (FVC)
Time frame: Baseline, week 6 and week 12
Forced vital capacity (FVC) is the maximal volume of air that can be expired while patient performs forced expiration as fast and as deep as possible using spirometry. We measured FVC at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
Change from baseline in FEV1/FVC ratio
Time frame: Baseline, week 6 and week 12
FEV1/FVC is used to differentiate obstructive from restrictive patterns by spirometry. We measuredFEV1/ FVC at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
Change from baseline in peak expiratory flow rate (PEFR).
Time frame: Baseline, week 6 and week 12
Peak expiratory flow rate (PEFR).is the maximal flow rate achieved during FVC maneuver using spirometry. We measured PEFR at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
Change from baseline in maximum voluntary ventilation (MVV)
Time frame: Baseline, week 6 and week 12
maximum voluntary ventilation (MVV) is the maximal volume of air that can be moved by voluntary ventilation in 1 minute while the patient breathes deeply and rapidly for 12 to 15 seconds using spirometry. We measured MVV at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).
1 secondary outcome
Six-minutes walking test
Time frame: Week 1,6 and 12
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 9 Mar 2021.
- Background: PubMed 22754664Yoshimi K, Ueki J, Seyama K, Takizawa M, Yamaguchi S, Kitahara E, Fukazawa S, Takahama Y, Ichikawa M, Takahashi K, Fukuchi Y. Pulmonary rehabilitation program including respiratory conditioning for chronic obstructive pulmonary disease (COPD): Improved hyperinflation and expiratory flow during tidal breathing. J Thorac Dis. 2012 Jun 1;4(3):259-64. doi: 10.3978/j.issn.2072-1439.2012.03.17.
- Background: PubMed 30664424Pehlivan E, Niksarlioglu EY, Balci A, Kilic L. The Effect of Pulmonary Rehabilitation on the Physical Activity Level and General Clinical Status of Patients with Bronchiectasis. Turk Thorac J. 2019 Jan 1;20(1):30-35. doi: 10.5152/TurkThoracJ.2018.18093.
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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.
Hatem A Emara, A.Prof principal investigator
Taibah 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 motorized movement therapy in people with Pulmonary Functions and Down Syndrome, run by Taibah 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 3 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 9 Mar 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?
Change from baseline in forced expiratory volume in 1st second (FEV1) (time frame: Baseline, week 6 and week 12). The study lists 5 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 NCT04787861, which also lists 2 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 9 Mar 2021.