Inspiratory Muscle Training in Patients With Acute Myocardial Infarction

NCT04491760 | Unknown DMC

• 1 other identifier: No.GDREC2019521H(R1)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Change in inspiratory muscle strength

  Static maximal inspiratory pressure (MIP) will be selected for the estimation of inspiratory muscle strength. A standard measurement using Powerbreathe® K5 and according to "ERS Statement on Respiratory Muscle Testing at Rest and during Exercise" published by European Respiratory Society (ERS) will be taken (Laveneziana, 2019). MIP test will be performed at baseline and at 30 days.

  at baseline, at 30 days

Secondary Outcomes (5)

• Pneumonia

  up to 30 days

• Major adverse cardiovascular events (MACE)

  up to 30 days

• Vital signs of participants during training

  up to 30 days

• Satisfactory assessment

  up to 30 days

• Length of stay

  up to 120 days

Study Arms (2)

Inspiratory muscle training

EXPERIMENTAL

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.

Other: Inspiratory Muscle Training

Control group

NO INTERVENTION

Participants will receive standard care according to the current guideline and clinical practice after primary PCI.

Interventions

Inspiratory Muscle Training 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.

Inspiratory muscle training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (4)

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

  PMID: 7154893 BACKGROUND

• 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.

  PMID: 30956204 BACKGROUND

• 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.

  PMID: 15699079 BACKGROUND

• 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.

  PMID: 33511161 DERIVED

Study Officials

• Yuanhui Liu, MD, PHD

  Guangdong Provincial People's Hospital, Guangzhou, China.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanhui Liu, MD, PHD

CONTACT

+86-13824440637; liuyuanhui@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 29, 2020
• Study Start: December 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: February 5, 2021

Record last verified: 2020-06

Locations

CN (1)