The Safety of the 6-minute Walk Test After Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

The Safety of the 6-minute Walk Test After Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03638050
• Other study ID #: 58277816.7.0000.5505
• Status: Recruiting
• Start date: August 17, 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Federal University of São Paulo
• Contact: Solange Guizilini, PhD
• Phone: 5511982887753
• Email: s_guizilini[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: The six-minute walk test (6MWT) is widely used as an instrument for assessing the functional capacity of cardiac patients. It's a simple, low cost test that better reflects day-to-day activities when compared to other tests. Its use to evaluate the functional capacity of cardiac patients in the in-hospital phase after acute myocardial infarction requires further studies. Objective: To evaluate the safety of the 6MWT performed on the third day after acute myocardial infarction (AMI). Methods: It's a cross-sectional study, to be accomplished in Hospital São Paulo - Federal University of Sao Paulo. Individuals, of both genders, aged 18 years and over, will be assessed on the third day after acute myocardial infarction. The 6MWT will be performed according to the norms of the American Thoracic Society. The distance covered during the 6MWT will be measured as weel as adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• AMI patients

Exclusion Criteria:

• Previous history of AMI

• Recurrent or refractory pain

• Presence of neuromuscular diseases

• Acute or chronic lung diseases

• Inability to perform the functional test

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Six-minute Walk Test

Intervention

Other:
• Functional Capacity Assessment
Individuals will be assessed on the third day after acute myocardial infarction. The six-minute walk test will be performed according to the norms of the American Thoracic Society.

Locations

Country	Name	City	State
Brazil	Graciana Santos Martinhão	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk test to measure functional capacity	By 6MWT assessing the functional capacity after acute myocardial infarction	Third day after acute myocardial infarction
Secondary	Angina	To assess the occurrence of angina during the 6MWT	Third day after acute myocardial infarction
Secondary	Dyspnea	To assess the occurrence of dyspnea during the 6MWT	Third day after acute myocardial infarction
Secondary	Pallor	To assess the occurrence of pallor during the 6MWT	Third day after acute myocardial infarction
Secondary	Sweating	To assess the occurrence of sweating during the 6MWT	Third day after acute myocardial infarction
Secondary	Cramps	To assess the occurrence of cramps during the 6MWT	Third day after acute myocardial infarction
Secondary	Lower limbs fatigue	To assess the occurrence of lower limbs fatigue during the 6MWT	Third day after acute myocardial infarction
Secondary	Dizziness	To assess the occurrence of dizziness during the 6MWT	Third day after acute myocardial infarction
Secondary	Hospitalization stay	Duration of stay in the hospital (in days) will be recorded.	Thirty days after acute myocardial infarction