AsthmatictrainingNCT04267666
Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women
A study testing incentive spirometer and Inspiratory muscle trainer device in people with Asthmatic and Postmenopausal Symptoms, run by Cairo University at 1 site in Egypt.
Trial summary
Objective: To compare the effectiveness of inspiratory muscle training (IMT) and incentive spirometer on ventilatory functions in post-menopausal asthmatic women. Participants and methods: A total of forty postmenopausal women suffering from asthma, their ages ranged from 50 to 60 years old, and their body mass index… Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asthmatic, Postmenopausal Symptoms
- What is being tested?
- incentive spirometer and Inspiratory muscle trainer device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 30 Dec 2019
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Forty postmenopausal women suffering from asthma
- Their ages were ranged from 50 to 60 years,
- their body mass index (BMI) don't exceed 30kg/m2.
- All participants were asthmatic patient
- clinically and medically stable cases
Who cannot join
- participant who had chest infection,
- malignant diseases,
- Patients with chest trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Inspiratory Muscle Strength Training and Incentive Spirometer on Ventilatory Function in Postmenopausal Asthmatic Women
Objective: To compare the effectiveness of inspiratory muscle training (IMT) and incentive spirometer on ventilatory functions in post-menopausal asthmatic women. Participants and methods: A total of forty postmenopausal women suffering from asthma, their ages ranged from 50 to 60 years old, and their body mass index of the patient don't exceed 30kg/m2. They were recruited from patient chest clinic in Kasr -El- Ainy Teaching Hospital, Cairo University, Egypt.
Read the detailed description
They signed a consent form, confidentiality was assured. They assigned into two groups (A) who received inspiratory muscle training in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training) while patients in group (B): received traditional chest physical therapy intervention and incentive spirometer, three sessions per week for six weeks. Patients in both groups were assessed before treatment (pre-training) then after treatment (post-training) (after 6 weeks) to measure lung functions using electronic spirometer. The training program was carried in the duration from January 2019 to July 2019.
- Conditions
- Asthmatic, Postmenopausal Symptoms
- Being tested
- incentive spirometer, Inspiratory muscle trainer device
- Keywords
- Inspiratory, Spirometer, Postmenopausal, asthma
- Medical subject headings
- Asthma, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incentive spirometerDevice
Patient had to produce a high inspiratory pressure. The ball serves as visible feedback of the inspiratory flow and indicates the obtained flow on a calibrated scale on the transparent cylinder of the spirometer. If the patient flows greater than 300 milliliters per second, the float ball in first chamber will rise. As patient flow increases to 600 milliliters per second the second ball float will rise. If the patient flow exceeds 900 milliliters per second all three will be suspended. Patient should encourage holding the balls up for a few seconds
Inspiratory muscle trainer deviceOther
The threshold trainer is a small plastic handheld device supplied by respironics. It includes a mouthpiece and a calibrated spring loaded valve. The valve controls a constant inspiratory pressure training load and the patient must generate the inspiratory pressure in order for the inspiratory valve to be opened and allow inhalation of air.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Strength Training | Experimental | in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training) Receives: Other: Inspiratory muscle trainer device |
| Incentive Spirometer | Experimental | incentive spirometer, three sessions per week for six weeks Receives: Device: incentive spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronic Spirometer (VIASYS- Health Care Microlab)
It was used for ventilatory functions measurement Ventilatory,reported as a number in liters (L).
Measured: 6 weeks
FVC (Forced vital capacity)
is one of the most useful tests to assess the overall ability to move air in and out of the lungs (ventilation). This is the maximum amount of air that can be forcefully and rapidly exhaled after a deep breath (maximal inspiration),reported as a number in liters (L)
Measured: 6 weeks
FEV1 (Forced expiratory volume)
is the volume of air forcibly exhaled in one second during the FVC test,reported as a number in liters (L)
Measured: 6 weeks
MVV (Maximum voluntary ventilation)
is the maximum air, which can be expired in a minute by deepest and fastest breathing, reported as a number in liters (L)
Measured: 6 weeks
Secondary outcomes (1)
Body mass index
It was used for measuring the weight and height of each patient to calculate the body mass index. BIM=weight (Kg) / height (m2).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Jul 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaticStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- inspiratory muscle training in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
- Investigators
- ghada eb elrefaye, professor, Principal investigator, Department of Physical Therapy for Women's Health, Cairo University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267666
- Sponsor's protocol ID
- CairoU9
- Acronym
- training
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Inspiratory Muscle Strength Training and Incentive Spirometer on Ventilatory Function in Postmenopausal Asthmatic Women
- ClinicalTrials.gov ID
- NCT04267666
- Acronym / sponsor ID
- training / CairoU9
- Conditions
- Asthmatic, Postmenopausal Symptoms
- Keywords
- Inspiratory, Spirometer, Postmenopausal, asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 13 Feb 2020 (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.
Objective: To compare the effectiveness of inspiratory muscle training (IMT) and incentive spirometer on ventilatory functions in post-menopausal asthmatic women. Participants and methods: A total of forty postmenopausal women suffering from asthma, their ages ranged from 50 to 60 years old, and their body mass index of the patient don't exceed 30kg/m2. They were recruited from patient chest clinic in Kasr -El- Ainy Teaching Hospital, Cairo University, Egypt.
Detailed description
They signed a consent form, confidentiality was assured. They assigned into two groups (A) who received inspiratory muscle training in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training) while patients in group (B): received traditional chest physical therapy intervention and incentive spirometer, three sessions per week for six weeks. Patients in both groups were assessed before treatment (pre-training) then after treatment (post-training) (after 6 weeks) to measure lung functions using electronic spirometer. The training program was carried in the duration from January 2019 to July 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- inspiratory muscle training in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training)
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Strength Training | Experimental | Other: Inspiratory muscle trainer devicein the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training) |
| Incentive Spirometer | Experimental | Device: incentive spirometerincentive spirometer, three sessions per week for six weeks |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Forty postmenopausal women suffering from asthma
- Their ages were ranged from 50 to 60 years,
- their body mass index (BMI) don't exceed 30kg/m2.
- All participants were asthmatic patient
- clinically and medically stable cases
Key exclusion criteria (3 listed)
- participant who had chest infection,
- malignant diseases,
- Patients with chest trauma.
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 |
|---|---|---|
| incentive spirometerPatient had to produce a high inspiratory pressure. The ball serves as visible feedback of the inspiratory flow and indicates the obtained flow on a calibrated scale on the transparent cylinder of the spirometer. If the patient flows greater than 300 milliliters per second, the float ball in first chamber will rise. As patient flow increases to 600 milliliters per second the second ball float will rise. If the patient flow exceeds 900 milliliters per second all three will be suspended. Patient should encourage holding the balls up for a few seconds | Device | Incentive Spirometer |
| Inspiratory muscle trainer deviceThe threshold trainer is a small plastic handheld device supplied by respironics. It includes a mouthpiece and a calibrated spring loaded valve. The valve controls a constant inspiratory pressure training load and the patient must generate the inspiratory pressure in order for the inspiratory valve to be opened and allow inhalation of air. | Other | Inspiratory Muscle Strength Training |
Primary outcome
Electronic Spirometer (VIASYS- Health Care Microlab)
Time frame: 6 weeks
It was used for ventilatory functions measurement Ventilatory,reported as a number in liters (L).
FVC (Forced vital capacity)
Time frame: 6 weeks
is one of the most useful tests to assess the overall ability to move air in and out of the lungs (ventilation). This is the maximum amount of air that can be forcefully and rapidly exhaled after a deep breath (maximal inspiration),reported as a number in liters (L)
FEV1 (Forced expiratory volume)
Time frame: 6 weeks
is the volume of air forcibly exhaled in one second during the FVC test,reported as a number in liters (L)
MVV (Maximum voluntary ventilation)
Time frame: 6 weeks
is the maximum air, which can be expired in a minute by deepest and fastest breathing, reported as a number in liters (L)
1 secondary outcome
Body mass index
Time frame: 6 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 13 Feb 2020.
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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.
ghada eb elrefaye, professor principal investigator
Department of Physical Therapy for Women's Health, Cairo University, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing incentive spirometer and Inspiratory muscle trainer device in people with Asthmatic and Postmenopausal Symptoms, run by Cairo 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 5 inclusion and 3 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 13 Feb 2020. 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?
Electronic Spirometer (VIASYS- Health Care Microlab) (time frame: 6 weeks). 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?
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 13 Feb 2020.