NCT04000893

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

June 25, 2019

Last Update Submit

June 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    Flow-mediated dilatation technique

    Pre and post 5 minutes exercise session

Secondary Outcomes (1)

  • Arterial stiffness

    Pre and post 5 minutes exercise session

Study Arms (2)

Resistance exercise session

EXPERIMENTAL

Acute isometric session, about 20 minutes.

Other: Resistance exercise session

Aerobic exercise session

ACTIVE COMPARATOR

Acute aerobic session, about 20 minutes.

Other: Resistance exercise session

Interventions

Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.

Also known as: Aerobic exercise session
Aerobic exercise sessionResistance exercise session

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to perform the randomized exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandre Lehnen

Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

Location

Related Publications (1)

  • 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.

Study Officials

  • Alexandre Lehnen, PhD

    Instituto de Cardiologia do Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 27, 2019

Study Start

August 1, 2018

Primary Completion

January 31, 2019

Study Completion

June 25, 2019

Last Updated

June 27, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations