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NCT03121911
Effects of Interval Physical Training on Expiratory Flow Limitation in Recent Myocardial Infarction
NA trial testing Interval Training (IT) in Expiratory Flow Limitation. Withdrawn.
28 February 2021
Quick facts
| Lead sponsor | Federal University of Uberlandia |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 4 July 2019 |
| Primary completion | 28 February 2021 |
| Estimated completion | 31 October 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Interval Training (IT)
- Inspiratory Muscle Training (IMT)
Conditions studied
- Expiratory Flow Limitation — all drugs for Expiratory Flow Limitation →
- Recent Myocardial Infarction — all drugs for Recent Myocardial Infarction →
Sponsor
Federal University of Uberlandia
Who can join
Adults 35 to 80, male only, with Expiratory Flow Limitation or Recent Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Introduction: Expiratory flow limitation (EFL) and ventilatory inefficiency during dynamic exercise have been identified in patients with recent myocardial infarction (RMI) with preserved ventricular and pulmonary function. However, it is not known what is the prevalence of EFL in this population and what are the effects of physical and respiratory training on this limitation. Objectives: To evaluate the prevalence of EFL and ventilatory inefficiency during dynamic exercise in individuals with uncomplicated RMI, and to evaluate the effects of interval physical training (IT) in addition to inspiratory muscle training (IMT), exclusive IT and absence of cardiopulmonary rehabilitation (CR) on EFL and ventilatory efficiency. Methods: 54 patients will be included, divided into three groups with 18 participants each. All will be submitted to evaluations of heart rate variability, hematological and biochemical profile, erythrocytes membrane deformability and stability, inflammatory markers, respiratory pressures, plethysmography, spirometry, carbon monoxide diffusion capacity, ankle brachial index, electrical bioimpedance, echocardiogram, quality of life questionnaires, cardiopulmonary exercise testing and constant load tests. Then, groups 1 (IT) and group 2 (IT + IMT) will participate in a physical training program for 12 weeks and will be re-evaluated after this period. In addition, they will be monitored for a 6 month period after discharge, with returns every two months to measure the energy expenditure through an accelerometer, and at the end of this period they will repeat all the tests again. Group 3 (absence of CR), will consist of patients who do not live in the city or those who can not participate in the CR program for any other reason, and will only participate in the evaluations.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03121911 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal University of Uberlandia
- Last refreshed: 5 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03121911.
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