Inspiratory Muscle Training in Patients With Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04491760
• Other study ID #: No.GDREC2019521H(R1)
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: June 2020
• Source: Guangdong Provincial People's Hospital
• Contact: Yuanhui Liu, MD, PHD
• Phone: +86-13824440637
• Email: liuyuanhui[@]gdph.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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

Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dubé 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). pii: 1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Major adverse cardiovascular events (MACE)	MACE is defined as: all cause death, recurrence of myocardial infarction, stroke at 30 days.	up to 30 days
Secondary	Vital signs of participants during training	The vital signs of participants during training in hospital will be recorded.	up to 30 days
Secondary	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
Secondary	Length of stay	Length of stay will be assessed by calculating the number of days the patient in the hospital.	up to 120 days