Pulmonary HypertensionNCT03385733
Inspiratory Muscle Training in Pulmonary Hypertension
A study testing inspiratory muscle training in people with Pulmonary Hypertension, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2017to 15 Feb 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Pulmonary Hypertension,
- NYHA functional class I-IV
- MIP pressure <80 cm h2O
Who cannot join
- COPD
- Conditions which can limit the assessments
- Insufficient cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Inspiratory Muscle Training on Exercise Capacity, Physical Activity and Quality of Life in Pulmonary Hypertension
The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.
Read the detailed description
Pulmonary hypertension (PH) is a condition which is seen with hemodynamic differences, pulmonary vascular resistance and right heart failure. Patients with pulmonary hypertension have, dyspnea, physical inactivity, reduced condition and respiratory muscle dysfunction. Aerobic exercise programs in patients with pulmonary hypertension are reported to result in improved exercise capacity and endurance of the patients, improvement in WHO functional class and quality of life, increased peak workload and increased peripheral muscle function. In recent years, few studies have investigated the efficacy of inspiratory muscle training in patients with PH.The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.
- Conditions
- Pulmonary Hypertension
- Being tested
- inspiratory muscle training
- Keywords
- pulmonary hypertension, inspiratory muscle training, functional capacity, physical activity
- Medical subject headings
- Hypertension, Pulmonary, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
The treatment group received IMT. Patients were trained using an inspiratory threshold-loading device
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training group | Experimental | Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with %30 MIP at home. Receives: Other: inspiratory muscle training |
| control group | No intervention | Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with 9 cmH2O pressure at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mouth pressures
MIP and MEP
Measured: 10 minutes
Secondary outcomes (4)
International Physical Activity Questionnaire-Short Form
Physical activity
Measured: 10 minutes
Minnesota Living with Heart Failure Questionnaire
quality of life
Measured: 15 minutes
Activity monitoring (Sense wear® Armband)
Metabolic holter
Measured: 3 days
6 minute walking test
functional capacity
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start10 Oct 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Patients will randomize into two groups as Group A: inspiratory muscle training, and Group B (control group)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University
- Responsible party
- Principal investigator, Goksen Kuran Aslan, Istanbul University
- Investigators
- Goksen Kuran Aslan, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385733
- Sponsor's protocol ID
- GAslan
- Other IDs
- BuketA
- Status last verified
- Feb 2018
- First submitted
- 21 Dec 2017
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the study will share with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inspiratory Muscle Training on Exercise Capacity, Physical Activity and Quality of Life in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03385733
- Acronym / sponsor ID
- GAslan
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, inspiratory muscle training, functional capacity, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Biruni University
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 28 Dec 2017 (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.
The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.
Detailed description
Pulmonary hypertension (PH) is a condition which is seen with hemodynamic differences, pulmonary vascular resistance and right heart failure. Patients with pulmonary hypertension have, dyspnea, physical inactivity, reduced condition and respiratory muscle dysfunction. Aerobic exercise programs in patients with pulmonary hypertension are reported to result in improved exercise capacity and endurance of the patients, improvement in WHO functional class and quality of life, increased peak workload and increased peripheral muscle function. In recent years, few studies have investigated the efficacy of inspiratory muscle training in patients with PH.The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will randomize into two groups as Group A: inspiratory muscle training, and Group B (control group)
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training group | Experimental | Other: inspiratory muscle trainingPatients will continue 8 weeks, 5 days, 2 times 15 minutes training program with %30 MIP at home. |
| control group | No intervention | –Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with 9 cmH2O pressure at home. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Pulmonary Hypertension,
- NYHA functional class I-IV
- MIP pressure <80 cm h2O
Key exclusion criteria (3 listed)
- COPD
- Conditions which can limit the assessments
- Insufficient cooperation
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 |
|---|---|---|
| inspiratory muscle trainingThe treatment group received IMT. Patients were trained using an inspiratory threshold-loading device | Other | Inspiratory muscle training group |
Primary outcome
mouth pressures
Time frame: 10 minutes
MIP and MEP
4 secondary outcomes
International Physical Activity Questionnaire-Short Form
Time frame: 10 minutes
Minnesota Living with Heart Failure Questionnaire
Time frame: 15 minutes
Activity monitoring (Sense wear® Armband)
Time frame: 3 days
6 minute walking test
Time frame: 15 minutes
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 1 Mar 2018.
- Individual participant dataSharing planned: No. Results of the study will share with other researchers
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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.
Goksen Kuran Aslan study director
Istanbul 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 inspiratory muscle training in people with Pulmonary Hypertension, run by Istanbul University at 1 site in Turkey (Türkiye).
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 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 1 Mar 2018. 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 Turkey (Türkiye). 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?
mouth pressures (time frame: 10 minutes). 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 1 Mar 2018.