Hypertension, PulmonaryNCT04152187
Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension
A study testing Inspiratory muscle training in people with Hypertension, Pulmonary, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the possible effects of inspiratory muscle training on cardiovascular, respiratory, physical and psychosocial functions in patients with PH. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2019to 18 Oct 2022
- 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
- According to the New York Heart Association functional class II - III
- Cases receiving stable medication for 3 months
Who cannot join
- Conditions which can limit the assessments
- Severe ischemic heart disease
- Acute cor pulmonale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension
This study aims to determine the possible effects of inspiratory muscle training on cardiovascular, respiratory, physical and psychosocial functions in patients with PH.
Read the detailed description
Pulmonary Hypertension (PH) is a hemodynamic finding related to increase in pulmonary artery pressure. Because PH disease is a progressive, rare disease, it is important for this disease group to prolong the life span and to increase the quality of life and functional capacity. PH patients have been shown to have weakness in peripheral and respiratory muscles.
Patients will be randomly assigned to the inspiratory muscle training and control group. Inspiratory muscle training will be initiated in accordance with the patient at a range of 40-60%. İnspiratory muscle training will be given based on the assessments by the physiotherapist. Patients with PH who come to the routine outpatient clinic and volunteer will be included in the study. The first session will be the evaluation session and the 8-week inspiratory muscle training will be given, the other group will be the control group only. Dyspnoea, diaphragm thickness, pulmonary function, respiratory and peripheral muscle strength, blood pressure, arterial stiffness, physical activity, anxiety, depression and quality of life assessments will be repeated before and after the treatment.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Inspiratory muscle training
- Keywords
- pulmonary hypertension, inspiratory muscle training, muscle weakness
- Medical subject headings
- Hypertension, Pulmonary, Muscle Weakness
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 will receive inspiratory muscle training.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training (IMT) | Experimental | Patients will receive IMT for 30 min (15x2), 7 times per week for 8 weeks using inspiratory muscle trainer device (PowerBreathe). During training, patients will be instructed to maintain diaphragmatic breathing. Inspiratory load will be set at 40-60% of maximum inspiratory pressure. Each week, six training sessions will be held at home and a training session will be supervised with physiotherapist. Receives: Other: Inspiratory muscle training |
| Control | No intervention | No additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
functional capacity
Measured: Change from Baseline at 8 weeks
Secondary outcomes (14)
Mouth pressures
Maximal inspiratory pressure, maximal expiratory pressure and endurance will be measure with mouth pressure device
Measured: Change from Baseline at 8 weeks
Modified Medical Research Council Dyspnea Scale
Modified Medical Research Council Dyspnea Scale is used to measure dyspnea. Higher scores indicate higher dyspnea.
Measured: Change from Baseline at 8 weeks
Forced vital capacity
Forced vital capacity is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Change from Baseline at 8 weeks
Forced expiratory volume in 1 second
The volume of air expired in the first second of expiration or forced expiratory volume in 1 second, especially when expressed as a ratio with the total amount of air expired during the forced vital capacity, is a good index of expiratory airways resistance.
Measured: Change from Baseline at 8 weeks
Diaphragma thickness
Diaphragma thickness will be measured by two dimensional ultrasonography
Measured: Change from Baseline at 8 weeks
Levels of blood pressure
Ambulatory blood pressure monitoring will be used for blood pressure measurement
Measured: Change from Baseline at 8 weeks
Arterial stiffness
During blood pressure measurements, augmentation index will be measured by non-invasive oscillations over the brachial artery.
Measured: Change from Baseline at 8 weeks
Isometric muscle strength
Isometric muscle strength for knee extensors and shoulder flexors and abductors
Measured: Change from Baseline at 8 weeks
Upper extremity exercise capacity
Upper extremity exercise capacity will be measured with Six-Minute Pegboard and Ring Test. In this test 4 iron rods, and a total of 20 rings are placed on a pegboard. At the end of six minutes, total number of rings placed will count.
Measured: Change from Baseline at 8 weeks
International Physical Activity Questionnaire-Short Form
The International Physical Activity Questionnaire-Short Form has 7 items listing activities and requests estimates of durations and frequencies for each activity engaged in over the past week. Durations are multiplied by known metabolic equivalents per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. Higher scores indicate higher physical activity level.
Measured: Change from Baseline at 8 weeks
Fatigue Impact Scale
The Fatigue Impact Scale is widely used to measure fatigue. It is a 40-item multidimensional scale measuring the physical, cognitive and social. Patients are asked to rate how much of a problem fatigue has caused them during the past month, including the day of testing, on a 5-point Likert-type scale, with response options ranging from 0 "no problem" to 4 "extreme problem". Loer scores indicate the better results
Measured: Change from Baseline at 8 weeks
Nottingham Health Profile
Health-related quality of life will be assessed using Nottingham Health Profile scale which is a general quality of life questionnaire that measures perceived health problems and their impact on normal daily activities. It has 38 items divided into six domains: energy level, pain, emotional reactions, sleep, social isolation and physical abilities. Items use yes/no answer format and each item is weighted. Total scores for each domain range from 0 to 100. Higher scores represent less quality of life in relevant domain.
Measured: Change from Baseline at 8 weeks
Changes in Anxiety and Depression
Anxiety and depression levels will be assessed by Hospital Anxiety and Depression Scale. The scale consists of 14 items, seven items for the anxiety subscale and seven for the depression subscale. Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Higher scores indicate
Measured: Change from Baseline at 8 weeks
Changes in Dyspnea
Dyspnea level will be questioned with the modified Borg Scale. Minimum value is 0 (no dyspnea), and maximum value is 10 (maximal dyspnea) Higher scores indicate higher fatigue levels.
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start11 Nov 2019
- Primary completion18 Aug 2022
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Ozcan Kahraman, Dokuz Eylul University
- Investigators
- Buse Ozcan Kahraman, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152187
- Sponsor's protocol ID
- Pulmonary Hypertension
- Other IDs
- 2018.KB.SAG.099
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2019
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04152187
- Acronym / sponsor ID
- Pulmonary Hypertension
- Conditions
- Hypertension, Pulmonary
- Keywords
- pulmonary hypertension, inspiratory muscle training, muscle weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 5 Nov 2019 (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.
This study aims to determine the possible effects of inspiratory muscle training on cardiovascular, respiratory, physical and psychosocial functions in patients with PH.
Detailed description
Pulmonary Hypertension (PH) is a hemodynamic finding related to increase in pulmonary artery pressure. Because PH disease is a progressive, rare disease, it is important for this disease group to prolong the life span and to increase the quality of life and functional capacity. PH patients have been shown to have weakness in peripheral and respiratory muscles.
Patients will be randomly assigned to the inspiratory muscle training and control group. Inspiratory muscle training will be initiated in accordance with the patient at a range of 40-60%. İnspiratory muscle training will be given based on the assessments by the physiotherapist. Patients with PH who come to the routine outpatient clinic and volunteer will be included in the study. The first session will be the evaluation session and the 8-week inspiratory muscle training will be given, the other group will be the control group only. Dyspnoea, diaphragm thickness, pulmonary function, respiratory and peripheral muscle strength, blood pressure, arterial stiffness, physical activity, anxiety, depression and quality of life assessments will be repeated before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training (IMT) | Experimental | Other: Inspiratory muscle trainingPatients will receive IMT for 30 min (15x2), 7 times per week for 8 weeks using inspiratory muscle trainer device (PowerBreathe). During training, patients will be instructed to maintain diaphragmatic breathing. Inspiratory load will be set at 40-60% of maximum inspiratory pressure. Each week, six training sessions will be held at home and a training session will be supervised with physiotherapist. |
| Control | No intervention | –No additional intervention |
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
- According to the New York Heart Association functional class II - III
- Cases receiving stable medication for 3 months
Key exclusion criteria (3 listed)
- Conditions which can limit the assessments
- Severe ischemic heart disease
- Acute cor pulmonale
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 will receive inspiratory muscle training. | Other | Inspiratory muscle training (IMT) |
Primary outcome
6 minute walk test
Time frame: Change from Baseline at 8 weeks
functional capacity
14 secondary outcomes
Mouth pressures
Time frame: Change from Baseline at 8 weeks
Modified Medical Research Council Dyspnea Scale
Time frame: Change from Baseline at 8 weeks
Forced vital capacity
Time frame: Change from Baseline at 8 weeks
Forced expiratory volume in 1 second
Time frame: Change from Baseline at 8 weeks
Diaphragma thickness
Time frame: Change from Baseline at 8 weeks
Levels of blood pressure
Time frame: Change from Baseline at 8 weeks
Arterial stiffness
Time frame: Change from Baseline at 8 weeks
Isometric muscle strength
Time frame: Change from Baseline at 8 weeks
Upper extremity exercise capacity
Time frame: Change from Baseline at 8 weeks
International Physical Activity Questionnaire-Short Form
Time frame: Change from Baseline at 8 weeks
Fatigue Impact Scale
Time frame: Change from Baseline at 8 weeks
Nottingham Health Profile
Time frame: Change from Baseline at 8 weeks
Changes in Anxiety and Depression
Time frame: Change from Baseline at 8 weeks
Changes in Dyspnea
Time frame: Change from Baseline at 8 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 15 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Buse Ozcan Kahraman principal investigator
Dokuz Eylul 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 Hypertension, Pulmonary, run by Dokuz Eylul 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 15 Nov 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 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?
6 minute walk test (time frame: Change from Baseline at 8 weeks). 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 Nov 2022.