4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Study Description
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020
Arms and Interventions
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.
Outcome Measures
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).


Eligibility Criteria
Layout table for eligibility information
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%)
Contacts and Locations

Locations
Layout table for location information
Turkey
Hatay Mustafa Kemal University
Hatay, Merkez, Turkey, 31010
Sponsors and Collaborators
Mustafa Kemal University
Investigators
Layout table for investigator information
Study Director: Aysel yıldız, assoc prof Marmara University Faculty of Health Sciences
Study Chair: Irem Hüzmeli, Msc 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
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date May 6, 2021
Actual Study Start Date  ICMJE April 15, 2019
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019) 		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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 19, 2019) 		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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
Official Title  ICMJE Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Angina, Stable
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Inspiratory muscle training group
    Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
    Intervention: Device: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
  • Sham Comparator: Sham group
    Sham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
    Intervention: Device: Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)
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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 30, 2020
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923153
Other Study ID Numbers  ICMJE MustafaKU 2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Irem Hüzmeli, Mustafa Kemal University
Study Sponsor  ICMJE Mustafa Kemal University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aysel yıldız, assoc prof Marmara University Faculty of Health Sciences
Study Chair: Irem Hüzmeli, Msc 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
PRS Account Mustafa Kemal University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯