Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Study Overview
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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.

Official Title
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Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Conditions
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Angina, Stable

Intervention / Treatment
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* Device: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
* Device: Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)


Participation Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inspiratory muscle training group<br>Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device | Device: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)<br>* 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.<br>|
| Sham Comparator: Sham group<br>Sham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device | Device: Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week | Mouth pressure device( MicroRPM, Micro Medical England) | Baseline, after 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Functional exercise capacity at 8 week | 6 minute walking test | Baseline, after 8 week | 
| Change from Pulmonary functions at 8 week | Spirometry | 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 | 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. | Baseline,after 8 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inspiratory muscle trainig, quality of life, aerobic capacity, depression, fatique