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Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

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ClinicalTrials.gov Identifier: NCT03923153
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Irem Hüzmeli, Mustafa Kemal University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Angina, Stable Device: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England) Device: Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Active Comparator: Inspiratory muscle training group
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)

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





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from Baseline Functional exercise capacity at 8 week [ Time Frame: Baseline, after 8 week ]
    6 minute walking test

  2. Change from Pulmonary functions at 8 week [ Time Frame: Baseline, after 8 week ]
    Spirometry

  3. 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


  4. 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.



Other Outcome Measures:
  1. Quality life [ Time Frame: Baseline, after 8 week ]
    Change of baseline quality of life at 8 week .Short Form (SF-36) Health Survey (Turkish version of scale) The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health: physical functioning (10 items) social functioning (2 items) role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general health perception (5 items). For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923153


Contacts
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Contact: Aysel Yıldız, assoc prof 90 216 330 20 70 ext 1321 aysel.yildiz@marmara.edu.tr
Contact: Irem Hüzmeli, Msc 903262455516 ext 15550 fztirem@gmail.com

Locations
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Turkey
Hatay Mustafa Kemal University Recruiting
Hatay, Merkez, Turkey, 31010
Contact: Irem Hüzmeli, msc    903262455516 ext 15550    fztirem@gmail.com   
Contact: oğuz akkuş, med. dr.    05326685870    oakkusfb@gmail.com   
Principal Investigator: Aysel Yıldız, phd         
Sub-Investigator: Fatih Yalçın, med. dr.         
Principal Investigator: Irem Hüzmeli, msc         
Principal Investigator: oğuz akkuş, med. dr         
Sponsors and Collaborators
Mustafa Kemal University
Investigators
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Study Director: Aysel yıldız, assoc prof Marmara University Faculty of Health Sciences
Study Chair: Irem Hüzmeli, Msc hatay mustafa kemal university
Principal Investigator: Oğuz Akkuş, assist prof hatay mustafa kemal university Faculty of Medicine
Study Chair: Fatih Yalçın, Prof. hatay mustafa kemal university Faculty of Medicine

Publications:
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Responsible Party: Irem Hüzmeli, lecturer, Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT03923153     History of Changes
Other Study ID Numbers: MustafaKU 2
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irem Hüzmeli, Mustafa Kemal University:
inspiratory muscle trainig
quality of life
aerobic capacity
depression
fatique
Additional relevant MeSH terms:
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Chest Pain
Pain
Respiratory Aspiration
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes