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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myocardial Infarction; Six-minute Walk Test
• Intervention / Treatment: Other: Functional Capacity Assessment

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Solange Guizilini, PhD; Phone Number: 5511982887753; Email: s_guizilini@yahoo.com.br
• Study Contact Backup: Name: Graciana Santos Martinhão; Phone Number: 5511999297715; Email: graciana_martinhao@hotmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 04024002
    • Recruiting
    • Graciana Santos Martinhão
    • Contact: Investigator; Phone Number: 5511999297715

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Sequential AMI patients admitted to hospitalization in the third day after myocardial infarction

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
In-hospital acute myocardial infarction patients; Functional Capacity Assessment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angina	To assess the occurrence of angina during the 6MWT	Third day after acute myocardial infarction
Dyspnea	To assess the occurrence of dyspnea during the 6MWT	Third day after acute myocardial infarction
Pallor	To assess the occurrence of pallor during the 6MWT	Third day after acute myocardial infarction
Sweating	To assess the occurrence of sweating during the 6MWT	Third day after acute myocardial infarction
Cramps	To assess the occurrence of cramps during the 6MWT	Third day after acute myocardial infarction
Lower limbs fatigue	To assess the occurrence of lower limbs fatigue during the 6MWT	Third day after acute myocardial infarction
Dizziness	To assess the occurrence of dizziness during the 6MWT	Third day after acute myocardial infarction
Hospitalization stay	Duration of stay in the hospital (in days) will be recorded.	Thirty days after acute myocardial infarction

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2016
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (ACTUAL): August 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

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: 58277816.7.0000.5505

Drug and device information, study documents

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