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Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty

Primary Purpose

Cardiac Rehabilitation, Aerobic Exercise, Resistance Exercise

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance exercise session
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Rehabilitation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Post-acute myocardial infarction patients
  • Ergometric test 30 days after the infarction
  • Ejection fraction> 40% (Simpson's method)
  • Regular use of optimized drugs

Exclusion Criteria:

  • Unable to perform the randomized exercise

Sites / Locations

  • Alexandre Lehnen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resistance exercise session

Aerobic exercise session

Arm Description

Acute isometric session, about 20 minutes.

Acute aerobic session, about 20 minutes.

Outcomes

Primary Outcome Measures

Endothelial function
Flow-mediated dilatation technique

Secondary Outcome Measures

Arterial stiffness
Pulse wave velocity technique

Full Information

First Posted
June 25, 2019
Last Updated
June 26, 2019
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT04000893
Brief Title
Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty
Official Title
Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

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
Cardiac Rehabilitation, as art and acting science multiprofessional, is based on the training with exercises that provides the post-infarct patients to satisfactorily re-establish the patient's clinical condition and that improve the functional capacity of these individuals. Evidence shows that aerobic exercise training provides improvements in the endothelial function of this population. However, we do not yet have strong evidence of other modalities of exercise in these parameters in post-infarction patients treated with angioplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Rehabilitation, Aerobic Exercise, Resistance Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance exercise session
Arm Type
Experimental
Arm Description
Acute isometric session, about 20 minutes.
Arm Title
Aerobic exercise session
Arm Type
Active Comparator
Arm Description
Acute aerobic session, about 20 minutes.
Intervention Type
Other
Intervention Name(s)
Resistance exercise session
Other Intervention Name(s)
Aerobic exercise session
Intervention Description
Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.
Primary Outcome Measure Information:
Title
Endothelial function
Description
Flow-mediated dilatation technique
Time Frame
Pre and post 5 minutes exercise session
Secondary Outcome Measure Information:
Title
Arterial stiffness
Description
Pulse wave velocity technique
Time Frame
Pre and post 5 minutes exercise session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post-acute myocardial infarction patients Ergometric test 30 days after the infarction Ejection fraction> 40% (Simpson's method) Regular use of optimized drugs Exclusion Criteria: Unable to perform the randomized exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Lehnen, PhD
Organizational Affiliation
Instituto de Cardiologia do Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandre Lehnen
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33596832
Citation
Kollet DP, Marenco AB, Belle NL, Barbosa E, Boll L, Eibel B, Waclawovsky G, Lehnen AM. Aerobic exercise, but not isometric handgrip exercise, improves endothelial function and arterial stiffness in patients with myocardial infarction undergoing coronary intervention: a randomized pilot study. BMC Cardiovasc Disord. 2021 Feb 17;21(1):101. doi: 10.1186/s12872-021-01849-2.
Results Reference
derived

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Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty

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