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Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Primary Purpose

Angina, Stable

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Angina, Stable focused on measuring inspiratory muscle trainig, quality of life, aerobic capacity, depression, fatique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%)

Sites / Locations

  • Hatay Mustafa Kemal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Inspiratory muscle training group

Sham group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week
Mouth pressure device( MicroRPM, Micro Medical England)

Secondary Outcome Measures

Change from Baseline Functional exercise capacity at 8 week
6 minute walking test
Change from Pulmonary functions at 8 week
Spirometry
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
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.

Full Information

First Posted
April 17, 2019
Last Updated
May 5, 2021
Sponsor
Mustafa Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT03923153
Brief Title
Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
Official Title
Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina, Stable
Keywords
inspiratory muscle trainig, quality of life, aerobic capacity, depression, fatique

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training group
Arm Type
Active Comparator
Arm Description
Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Sham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
Intervention Description
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
Intervention Name(s)
Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)
Intervention Description
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 Measure Information:
Title
Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week
Description
Mouth pressure device( MicroRPM, Micro Medical England)
Time Frame
Baseline, after 8 week
Secondary Outcome Measure Information:
Title
Change from Baseline Functional exercise capacity at 8 week
Description
6 minute walking test
Time Frame
Baseline, after 8 week
Title
Change from Pulmonary functions at 8 week
Description
Spirometry
Time Frame
Baseline, after 8 week
Title
Fatigue
Description
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
Time Frame
Baseline, after 8 week
Title
Depression
Description
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.
Time Frame
Baseline,after 8 week
Other Pre-specified Outcome Measures:
Title
Quality life
Description
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).
Time Frame
Baseline, after 8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysel yıldız, assoc prof
Organizational Affiliation
Marmara University Faculty of Health Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Irem Hüzmeli, Msc
Organizational Affiliation
Mustafa Kemal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Oğuz Akkuş, assist prof
Organizational Affiliation
hatay mustafa kemal university Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatih Yalçın, Prof.
Organizational Affiliation
hatay mustafa kemal university Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Hatay Mustafa Kemal University
City
Hatay
State/Province
Merkez
ZIP/Postal Code
31010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21645830
Citation
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.
Results Reference
background
PubMed Identifier
29394453
Citation
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.
Results Reference
background
PubMed Identifier
12186831
Citation
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.
Results Reference
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Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

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