Angina, StableNCT03923153

Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

A study testing Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England) in people with Angina, Stable, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Angina, Stable
What is being tested?: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Apr 2019to 30 Aug 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

No contraindication for pulmonary physiotherapy
Anjina patients who are clinically stable
have no other disease that may affect respiratory function
Individuals who have the good cooperation

Who cannot join

Patients under the age of 18
Pregnancy
Active infection
Patients with known malignancies
patients without consent
known arrhythmia, dilated or hypertrophic cardiomyopathy, heart failure (EF <40%)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hatay Mustafa Kemal University
Hatay, Merkez, 31010

Other trials in Turkey (Türkiye)

About this study

Stable angina is a cardiac pathology that adversely affects the quality of life of the patient, which develops as a result of narrowing of the coronary vessels developing in atherosclerotic ground and / or impaired oxygen supply-need balance. Studies widely investigated the effects of exercise training in patients with stable angina. No study investigated the effects of inspiratory muscle training in patients with stable angina.Investigators aimed to investigate the effects of inspiratory muscle training on aerobic exercise capacity, quality of life, depression, peripheral and respiratory (MIP, MEP) muscle strength, pulmonary function, dyspnea, fatigue in stable angina patients.

Read the detailed description

Patients with stable angina will be included. Primary outcome measurement is inspiratory muscle strength, secondary outcomes are functional exercise capacity, peripheral muscle strength, pulmonary functions, maximal exercise capacity, fatigue, quality of life, depression.

Conditions: Angina, Stable
Being tested: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England), Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)
Keywords: inspiratory muscle trainig, quality of life, aerobic capacity, depression, fatique
Medical subject headings: Angina, Stable, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)Device
Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 30% of maximal inspiratory pressure (MIP).
The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload.
The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.
Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)Device
Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 10% of maximal inspiratory pressure (MIP).
The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload.
The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.

Study groups in NCT03923153
Study group	Role	What they receive
Inspiratory muscle training group	Active comparator	Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device Receives: Device: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
Sham group	Sham comparator	Sham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device Receives: Device: Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week
Mouth pressure device( MicroRPM, Micro Medical England)
Measured: Baseline, after 8 week

Secondary outcomes (4)

Change from Baseline Functional exercise capacity at 8 week
6 minute walking test
Measured: Baseline, after 8 week
Change from Pulmonary functions at 8 week
Spirometry
Measured: Baseline, after 8 week
Fatigue
Change from baseline Fatigue Severity Scale (FSS) (Turkish version of scale) at 8 weeek.
Patient choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue
Measured: Baseline, after 8 week
Depression
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) (Turkish version of scale) at 8 week.
This assessment tool contains 10 items with a score from 0 to 6, thus the maximum score is 60. A higher score indicates a more severe depression.
Measured: Baseline,after 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201930 Aug 2020

First posted22 Apr 2019
Study start15 Apr 2019
Primary completion30 Aug 2020
Study completion30 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Angina, StableStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03923153
Sponsor's protocol ID: MustafaKU 2
Status last verified: May 2021
First submitted: 17 Apr 2019
Last updated: 6 May 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kellens I, Cannizzaro F, Gouilly P, Crielaard JM. [Inspiratory muscles strength training in recreational athletes]. Rev Mal Respir. 2011 May;28(5):602-8. doi: 10.1016/j.rmr.2011.01.008. Epub 2011 Apr 19. French.
PubMed 21645830
Long L, Anderson L, Dewhirst AM, He J, Bridges C, Gandhi M, Taylor RS. Exercise-based cardiac rehabilitation for adults with stable angina. Cochrane Database Syst Rev. 2018 Feb 2;2(2):CD012786. doi: 10.1002/14651858.CD012786.pub2.
PubMed 29394453
American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
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Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris

All Angina, Stable trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
ClinicalTrials.gov ID: NCT03923153
Acronym / sponsor ID: MustafaKU 2
Conditions: Angina, Stable
Keywords: inspiratory muscle trainig, quality of life, aerobic capacity, depression, fatique
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Mustafa Kemal UniversityUniversity, hospital or other
Study start: 15 Apr 2019 (actual)
Primary completion: 30 Aug 2020 (actual)
Study completion: 30 Aug 2020 (actual)
First posted: 22 Apr 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Inspiratory muscle training group	Active comparator	Device: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
Sham group	Sham comparator	Device: Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)Sham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

No contraindication for pulmonary physiotherapy
Anjina patients who are clinically stable
have no other disease that may affect respiratory function
Individuals who have the good cooperation

Key exclusion criteria (6 listed)

Patients under the age of 18
Pregnancy
Active infection
Patients with known malignancies
patients without consent

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 training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 30% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.	Device	Inspiratory muscle training group
Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 10% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.	Device	Sham group

Primary outcome

Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week
Time frame: Baseline, after 8 week
Mouth pressure device( MicroRPM, Micro Medical England)

4 secondary outcomes

Change from Baseline Functional exercise capacity at 8 week
Time frame: Baseline, after 8 week
Change from Pulmonary functions at 8 week
Time frame: Baseline, after 8 week
Fatigue
Time frame: Baseline, after 8 week
Depression
Time frame: Baseline,after 8 week

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 6 May 2021.
Background: PubMed 21645830Kellens I, Cannizzaro F, Gouilly P, Crielaard JM. [Inspiratory muscles strength training in recreational athletes]. Rev Mal Respir. 2011 May;28(5):602-8. doi: 10.1016/j.rmr.2011.01.008. Epub 2011 Apr 19. French.
Background: PubMed 29394453Long L, Anderson L, Dewhirst AM, He J, Bridges C, Gandhi M, Taylor RS. Exercise-based cardiac rehabilitation for adults with stable angina. Cochrane Database Syst Rev. 2018 Feb 2;2(2):CD012786. doi: 10.1002/14651858.CD012786.pub2.
Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
Individual participant dataSharing planned: No

Related trials for Angina, Stable

Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris

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.

Aysel yıldız, assoc prof study director

Marmara University Faculty of Health Sciences

Irem Hüzmeli, Msc study chair

Mustafa Kemal University

Oğuz Akkuş, assist prof principal investigator

Mustafa Kemal University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 6 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 6 May 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 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. Some participants in this study may receive a placebo. 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 of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week (time frame: Baseline, after 8 week). 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 NCT03923153, which also lists 3 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 6 May 2021.