Inspiratory Muscle Training in Patients With Acute Myocardial Infarction

NCT ID: NCT04491760

Last Updated: 2021-02-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-05-30

Brief Summary

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Pneumonia is uncommon high among patients with acute myocardial infarction (AMI), which increases adverse clinical events and prolongs the hospital stay. Inspiratory muscle training (IMT) is able to improve inspiratory muscle strength and prevent pneumonia in patients undergoing cardiac surgery including coronary artery bypass grafting. Thus, the investigators design the study mainly aim to evaluate the 30 days IMT for the change of inspiratory muscle strength, and also to observe its potentially effect on reducing pneumonia, in participants who accepted primary percutaneous coronary intervention (PCI) and at a high risk of pneumonia.

Detailed Description

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This is a single center, prospective, randomized controlled study. All participants will be followed up until 30 days after randomized.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years, patients with AMI undergoing primary PCI, admitted to cardiac intensive care unit and at a high pneumonia risk \[2 or more of the following parameters are regarded as high risk for pneumonia: 1. Age \> 55 years, 2. Diabetes mellitus, 3. Smoking at present, 4. Chronic kidney disease: estimated glomerular filtration rate \< 60 mL/min/1.73m2, 5. Forced expiratory volume in the first second of expiration (FEV1) \< 80% predicted and FEV1/forced vital capacity (FVC) \< 70% predicted\]
* be able to understand and agree with informed consent

Exclusion Criteria

* a history of cerebrovascular accident
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuanhui Liu, MD, PHD

Role: CONTACT

+86-13824440637

Facility Contacts

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Yuanhui Liu, MD, PHD

Role: primary

+86-13824440637

References

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Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

Reference Type BACKGROUND
PMID: 7154893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30956204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15699079 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33511161 (View on PubMed)

Other Identifiers

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No.GDREC2019521H(R1)

Identifier Type: -

Identifier Source: org_study_id

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