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出境医 / 临床实验 / Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty
Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Rehabilitation Aerobic Exercise Resistance Exercise | Other: Resistance exercise session | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty: Randomized Clinical Trial |
| Actual Study Start Date : | August 1, 2018 |
| Actual Primary Completion Date : | January 31, 2019 |
| Actual Study Completion Date : | June 25, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Resistance exercise session
Acute isometric session, about 20 minutes.
|
Other: Resistance exercise session
Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.
Other Name: Aerobic exercise session
|
|
Active Comparator: Aerobic exercise session
Acute aerobic session, about 20 minutes.
|
Other: Resistance exercise session
Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.
Other Name: Aerobic exercise session
|
Outcome Measures
Primary Outcome Measures :
- Endothelial function [ Time Frame: Pre and post 5 minutes exercise session ]Flow-mediated dilatation technique
Secondary Outcome Measures :
- Arterial stiffness [ Time Frame: Pre and post 5 minutes exercise session ]Pulse wave velocity technique
Eligibility Criteria
| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Locations
| Brazil | |
| Alexandre Lehnen | |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001 | |
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Investigators
| Principal Investigator: | Alexandre Lehnen, PhD | Instituto de Cardiologia do Rio Grande do Sul |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 25, 2019 | ||||
| First Posted Date ICMJE | June 27, 2019 | ||||
| Last Update Posted Date | June 27, 2019 | ||||
| Actual Study Start Date ICMJE | August 1, 2018 | ||||
| Actual Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Endothelial function [ Time Frame: Pre and post 5 minutes exercise session ] Flow-mediated dilatation technique
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Arterial stiffness [ Time Frame: Pre and post 5 minutes exercise session ] Pulse wave velocity technique
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty | ||||
| Official Title ICMJE | Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty: Randomized Clinical Trial | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE |
|
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| Intervention ICMJE | Other: Resistance exercise session
Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.
Other Name: Aerobic exercise session
|
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| Study Arms ICMJE |
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| Publications * | Kollet DP, Marenco AB, Bellé 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
20 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | June 25, 2019 | ||||
| Actual Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Brazil | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04000893 | ||||
| Other Study ID Numbers ICMJE | AMI and exercise | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Instituto de Cardiologia do Rio Grande do Sul | ||||
| Study Sponsor ICMJE | Instituto de Cardiologia do Rio Grande do Sul | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Instituto de Cardiologia do Rio Grande do Sul | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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