Inspiratory Muscle Training in Patients With Acute Myocardial Infarction
Primary Purpose
Acute Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sponsored by
About this trial
This is an interventional prevention trial for Acute Myocardial Infarction
Eligibility Criteria
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)
Sites / Locations
- Guangdong Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Inspiratory muscle training
Control group
Arm Description
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.
Participants will receive standard care according to the current guideline and clinical practice after primary PCI.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Major adverse cardiovascular events (MACE)
MACE is defined as: all cause death, recurrence of myocardial infarction, stroke at 30 days.
Vital signs of participants during training
The vital signs of participants during training in hospital will be recorded.
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.
Length of stay
Length of stay will be assessed by calculating the number of days the patient in the hospital.
Full Information
NCT ID
NCT04491760
First Posted
June 16, 2020
Last Updated
February 4, 2021
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04491760
Brief Title
Inspiratory Muscle Training in Patients With Acute Myocardial Infarction
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This is a single center, prospective, randomized controlled study. All participants will be followed up until 30 days after randomized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will receive standard care according to the current guideline and clinical practice after primary PCI.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in inspiratory muscle strength
Description
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.
Time Frame
at baseline, at 30 days
Secondary Outcome Measure Information:
Title
Pneumonia
Description
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.
Time Frame
up to 30 days
Title
Major adverse cardiovascular events (MACE)
Description
MACE is defined as: all cause death, recurrence of myocardial infarction, stroke at 30 days.
Time Frame
up to 30 days
Title
Vital signs of participants during training
Description
The vital signs of participants during training in hospital will be recorded.
Time Frame
up to 30 days
Title
Satisfactory assessment
Description
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.
Time Frame
up to 30 days
Title
Length of stay
Description
Length of stay will be assessed by calculating the number of days the patient in the hospital.
Time Frame
up to 120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanhui Liu, MD, PHD
Phone
+86-13824440637
Email
liuyuanhui@gdph.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanhui Liu, MD, PHD
Organizational Affiliation
Guangdong Provincial People's Hospital, Guangzhou, China.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanhui Liu, MD, PHD
Phone
+86-13824440637
Email
liuyuanhui@gdph.org.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
7154893
Citation
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Results Reference
background
PubMed Identifier
30956204
Citation
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.
Results Reference
background
PubMed Identifier
15699079
Citation
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.
Results Reference
background
PubMed Identifier
33511161
Citation
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.
Results Reference
derived
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Inspiratory Muscle Training in Patients With Acute Myocardial Infarction
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