Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

NCT ID: NCT03923153

Last Updated: 2021-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2020-08-30

Brief Summary

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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.

Detailed Description

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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

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Angina, Stable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Inspiratory muscle training group

Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device

Group Type ACTIVE_COMPARATOR

Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)

Intervention Type 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

Sham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device

Group Type SHAM_COMPARATOR

Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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%)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mustafa Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Irem Hüzmeli

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysel yıldız, assoc prof

Role: STUDY_DIRECTOR

Marmara University Faculty of Health Sciences

Irem Hüzmeli, Msc

Role: STUDY_CHAIR

Mustafa Kemal University

Oğuz Akkuş, assist prof

Role: PRINCIPAL_INVESTIGATOR

hatay mustafa kemal university Faculty of Medicine

Fatih Yalçın, Prof.

Role: STUDY_CHAIR

hatay mustafa kemal university Faculty of Medicine

Locations

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Hatay Mustafa Kemal University

Hatay, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21645830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29394453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12186831 (View on PubMed)

Other Identifiers

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MustafaKU 2

Identifier Type: -

Identifier Source: org_study_id

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