Inspiratory Muscle Training in Patients With Acute Myocardial Infarction

Feasibility of Inspiratory Muscle Training in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention and Complicated With High Risk of Pneumonia: a Randomized Controlled Trail

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Other: Inspiratory Muscle Training

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuanhui Liu, MD, PHD; Phone Number: +86-13824440637; Email: liuyuanhui@gdph.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Yuanhui Liu, MD, PHD; Phone Number: +86-13824440637; Email: liuyuanhui@gdph.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: Control group; Participants will receive standard care according to the current guideline and clinical practice after primary PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumonia	The diagnosis of pneumonia is based on guidelines of the American Thoracic Society [American Thoracic Society (ATS) and Infectious Diseases Society of America (IDSA), 2005]. The events of pneumonia will be followed and recorded by experienced doctors when in hospital. After discharged, participants will be followed by the experienced researches, once pneumonia is considered as possible, guidance will be provided for the participants to complete necessary examines, until 30 days.	up to 30 days
Major adverse cardiovascular events (MACE)	MACE is defined as: all cause death, recurrence of myocardial infarction, stroke at 30 days.	up to 30 days
Vital signs of participants during training	The vital signs of participants during training in hospital will be recorded.	up to 30 days
Satisfactory assessment	Satisfaction of the participants in inspiratory muscle training (IMT) group will be evaluated using a questionnaire at the day of discharged and at 30 days.	up to 30 days
Length of stay	Length of stay will be assessed by calculating the number of days the patient in the hospital.	up to 120 days

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Yuanhui Liu, MD, PHD, Guangdong Provincial People's Hospital, Guangzhou, China.

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: No.GDREC2019521H(R1)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No