Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 30, 2020

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.

Interventions

  • Device: 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: 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.

Arms, Groups and Cohorts

  • Active Comparator: Inspiratory muscle training group
    • Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
  • Sham Comparator: Sham group
    • Sham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • Change from Baseline Functional exercise capacity at 8 week
    • Time Frame: Baseline, after 8 week
    • 6 minute walking test
  • Change from Pulmonary functions at 8 week
    • Time Frame: Baseline, after 8 week
    • Spirometry
  • Fatigue
    • Time Frame: Baseline, after 8 week
    • 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
  • Depression
    • Time Frame: Baseline,after 8 week
    • 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.

Participating in This Clinical Trial

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%)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mustafa Kemal University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Irem Hüzmeli, lecturer – Mustafa Kemal University
  • Overall Official(s)
    • Aysel yıldız, assoc prof, Study Director, Marmara University Faculty of Health Sciences
    • Irem Hüzmeli, Msc, Study Chair, hatay mustafa kemal university
    • Oğuz Akkuş, assist prof, Principal Investigator, hatay mustafa kemal university Faculty of Medicine
    • Fatih Yalçın, Prof., Study Chair, hatay mustafa kemal university Faculty of Medicine
  • Overall Contact(s)
    • Aysel Yıldız, assoc prof, 90 216 330 20 70, aysel.yildiz@marmara.edu.tr

References

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.

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:CD012786. doi: 10.1002/14651858.CD012786.pub2. Review.

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.

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