NCT03638050

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

July 27, 2018

Last Update Submit

August 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Angina

    Third day after acute myocardial infarction

  • Dyspnea

    Third day after acute myocardial infarction

  • Pallor

    Third day after acute myocardial infarction

  • Sweating

    Third day after acute myocardial infarction

  • Cramps

    Third day after acute myocardial infarction

  • +3 more secondary outcomes

Study Arms (1)

In-hospital acute myocardial infarction patients

Functional Capacity Assessment

Other: Functional Capacity Assessment

Interventions

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.

In-hospital acute myocardial infarction patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • AMI patients

You may not qualify if:

  • Previous history of AMI
  • Recurrent or refractory pain
  • Presence of neuromuscular diseases
  • Acute or chronic lung diseases
  • Inability to perform the functional test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graciana Santos Martinhão

São Paulo, 04024002, Brazil

RECRUITING

Central Study Contacts

Solange Guizilini, PhD

CONTACT

Graciana Santos Martinhão

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 20, 2018

Study Start

August 17, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations