Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2019
CompletedFirst Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedMay 6, 2021
May 1, 2021
1.4 years
April 17, 2019
May 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change from Baseline Functional exercise capacity at 8 week
Baseline, after 8 week
Change from Pulmonary functions at 8 week
Baseline, after 8 week
Fatigue
Baseline, after 8 week
Depression
Baseline,after 8 week
Other Outcomes (1)
Quality life
Baseline, after 8 week
Study Arms (2)
Inspiratory muscle training group
ACTIVE COMPARATORInspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
Sham group
SHAM COMPARATORSham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hatay Mustafa Kemal University
Hatay, Merkez, 31010, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 21645830BACKGROUNDLong 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.
PMID: 29394453BACKGROUNDAmerican 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.
PMID: 12186831BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Mustafa Kemal University
- STUDY CHAIR
Fatih Yalçın, Prof.
Mustafa Kemal University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
April 17, 2019
First Posted
April 22, 2019
Study Start
April 15, 2019
Primary Completion
August 30, 2020
Study Completion
August 30, 2020
Last Updated
May 6, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share