Inspiratory Muscle Training in Patients With Acute Myocardial Infarction
NCT ID: NCT04491760
Last Updated: 2021-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-12-01
2021-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Inspiratory muscle training
Inspiratory muscle training (IMT) will be perform for 15 minutes each time, twice a day, training every day from 12h to 24h after primary percutaneous coronary intervention (PCI) to 30 days since randomized.
Inspiratory Muscle Training
The inspiratory muscle training (IMT) will be carried out with a load of 30% of maximal inspiratory pressure (MIP) using a threshold inspiratory muscle trainer (c-type, Shengchang medical equipment factory, Yuyao city, China) at the beginning. During the hospital period, the resistance will increase incrementally, based on the rate of perceived exertion scored on the Borg scale (Borg, 1982). If the rate of perceived exertion less than 5, the resistance of the inspiratory threshold trainer will then be increase incrementally by 5%. The load for home-based IMT training will be set as the highest training load in the hospital. All patients will be required in sitting position during training, wearing nose-clips.
Control group
Participants will receive standard care according to the current guideline and clinical practice after primary PCI.
No interventions assigned to this group
Interventions
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Inspiratory Muscle Training
The inspiratory muscle training (IMT) will be carried out with a load of 30% of maximal inspiratory pressure (MIP) using a threshold inspiratory muscle trainer (c-type, Shengchang medical equipment factory, Yuyao city, China) at the beginning. During the hospital period, the resistance will increase incrementally, based on the rate of perceived exertion scored on the Borg scale (Borg, 1982). If the rate of perceived exertion less than 5, the resistance of the inspiratory threshold trainer will then be increase incrementally by 5%. The load for home-based IMT training will be set as the highest training load in the hospital. All patients will be required in sitting position during training, wearing nose-clips.
Eligibility Criteria
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Inclusion Criteria
* be able to understand and agree with informed consent
Exclusion Criteria
* treat with immunosuppressive medication for 30 days before
* neuromuscular disorder
* cardiovascular instability (such as aortic dissection or unstable hemodynamics)
* a history of Coronary Artery Bypass Grafting (CABG)
* expected survival is less than 6 months due to noncardiogenic disease
* participated in other drugs and devices studies within 30 days
* confirmed as ventricular aneurysm
* other conditions not suit for the study after the discussion among the researchers (eg: poor compliance, unable to cooperate for the training)
18 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Yuanhui Liu, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital, Guangzhou, China.
Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
Liu Y, Dai Y, Liu Z, Zhan H, Zhu M, Chen X, Zhang S, Zhang G, Xue L, Duan C, Chen J, Guo L, He P, Tan N. The Safety and Efficacy of Inspiratory Muscle Training for Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention: Study Protocol for a Randomized Controlled Trial. Front Cardiovasc Med. 2021 Jan 12;7:598054. doi: 10.3389/fcvm.2020.598054. eCollection 2020.
Other Identifiers
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No.GDREC2019521H(R1)
Identifier Type: -
Identifier Source: org_study_id
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