Effects of Interval Physical Training on Expiratory Flow Limitation in Recent Myocardial Infarction

NCT03121911 | Withdrawn DMC

• 1 other identifier: 005040/2017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Expiratory Flow Limitation; Recent Myocardial Infarction

Keywords

Recent Myocardial Infarction; Interval Physical Training; Inspiratory Muscle Training; Expiratory Flow Limitation; Ventilatory Efficiency; Inflammatory Markers; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• Change on Expiratory Flow Limitation (EFL)

  Two constant workload exercise tests (CWET) will evaluate the EFL and the ventilatory strategy at the VAT and VAT + 25%, with rest interval of 30 to 60 minutes between tests. Duration: 20 minutes each test. Patients will be monitored with optoelectronic plethysmography and transthoracic electrical cardioimpedance. After a 2-minute rest period in a cycle ergometer (clinical evaluation, metabolic, cardiovascular, ventilatory and gas exchange records, and Borg), the effort will start at zero load (60 rpm). The pre-established intensity corresponding to VAT and 25% above VAT will be placed in the 3rd minute of exercise by single increment for ten minutes. In the last four minutes the flow-volume loops will be measured. After each test there will be an active recovery for 3 minutes, and 2 minutes of rest. EFL will be evaluated by comparing tidal flow-volume loops, obtained after an inspiratory capacity maneuver, with the resting maximal flow-volume loop measured before each CWET.

  Change from baseline EFL, after 12 weeks at the end of the rehabilitation program and 6 months after release from rehabilitation program

Secondary Outcomes (18)

• Change on Ankle Brachial Index (ABI)

  Change from baseline ABI, after 12 weeks at the end of the rehabilitation program and 6 months after release from rehabilitation program

• Change on Heart Rate Variability (HRV) at rest

  Change from baseline HRV, after 12 weeks at the end of the rehabilitation program and 6 months after release from rehabilitation program

• Change on Maximal Inspiratory Pressure (MIP)

  Change from baseline MIP, once a week during the training period, after 12 weeks at the end of the rehabilitation program and 6 months after release from rehabilitation program

• Change on Maximal Expiratory Pressure (MEP)

  Change from baseline MEP, once a week during the training period, after 12 weeks at the end of the rehabilitation program and 6 months after release from rehabilitation program

• Change on Incremental Cardiopulmonary Exercise Testing (CPET)

  Change from baseline CPET, every 4 weeks during the training period, after 12 weeks at the end of the rehabilitation program and 6 months after release from rehabilitation

Study Arms (3)

Group 1 - Interval Training (IT)

EXPERIMENTAL

All participants will be submitted to several exams of cardiac and pulmonary functions. Then, group 1 (IT) will participate in a physical training program for 12 weeks and will be re-evaluated after this period. After discharge, they will be monitored for an aditional period of 6 months, with returns every two months to measure the energy expenditure (accelerometer). At the end of this period all the tests will be repeated. Each exercise session will last for 60 minutes and will be divided into three parts as follows: warm up (10 minutes); interval training (IT) - 30 minutes of IT performed in a cycle ergometer, divided into 6 levels of intensity based on the ventilatory anaerobic threshold found in CPET (70%, 80%, 100% and 110%); cooling down (10 minutes).

Other: Interval Training (IT)

Group 2 - IT + IMT

EXPERIMENTAL

All participants will be submitted to the same evaluations before and after training, and 6 months after discharge. Group 2 (IT + inspiratory muscle training (IMT)) will participate in a 12 week physical training program. After discharge, they will be monitored for an aditional period of 6 months, with returns every two months to measure the energy expenditure. The group 2 will perform the IMT session at the end of the warm-up exercises, prior to the beginning of the IT on a cycloergometer. IMT session consists of 2 series of 12 inspirations with a 60% of MIP. Participant will be asked to inhale quickly and deeply, as quickly as possible, with a 2 minutes interval between series. All the others exercises will be identical between group 1 and 2.

Other: Interval Training (IT); Other: Inspiratory Muscle Training (IMT)

Group 3 - Absence of rehabilitation

NO INTERVENTION

Group 3 (absence of rehabilitation) will be made up of those patients who for any reason do not agree to participate in the rehabilitation program, such as those who do not live in the city, and will remain without intervention. All participants in this group will perform all the evaluations procedures, comprised 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 (SF-36 and MacNew QLMI), cardiopulmonary exercise testing and constant load tests.

Interventions

Interval Training (IT) OTHER

Each exercise session will consist of: 1. warm up (10 minutes)- stretches and calisthenics exercises of low to moderate intensity; 2. interval training (IT) - 30 minutes of IT performed in a cycle ergometer, divided into 6 levels of intensity based on the ventilatory anaerobic threshold (VAT) found in CPET: Level 1 - 5 minutes in moderate intensity, at 80% of power reached in VAT; Levels 2 and 4 - 5 minutes of moderate to high intensity, at 100% of VAT; Levels 3 and 5 - 5 minutes of moderate to high intensity, 110% of VAT; Level 6 - 5 minutes in moderate intensity, at 70% of VAT. 3. cooling down (10 minutes) - stretching, and breathing exercises. An CPET will be performed every four weeks to adjust the intensity of training.

Group 1 - Interval Training (IT); Group 2 - IT + IMT

Inspiratory Muscle Training (IMT) OTHER

The IMT session will take place just after the warm-up exercises and consist of 2 series of 12 inspirations with a 60% of Maximal Inspiratory Pressure (MIP) with the equipment POWERbreathe Plus Medic® (POWERbreathe International Ltd, Warwickshire, UK). The patient will be instructed to remain seated with a nasal clip during the IMT series to avoid nasal air leakage and will be asked to inhale quickly and deeply, as quickly as possible, with a 2 minute interval between series. The training load will be adjusted weekly by a new evaluation of MIP to maintain the intensity of the exercise within the proposed value. All the others exercises will be identical between group 1 and 2.

Group 2 - IT + IMT

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men
• Aged 35 to 80 years
• Recent myocardial infarction (RMI), between 15 and 45 days post-event, being the 1st MI event
• Left ventricular ejection fraction (LVEF) ≥ 50%
• Preserved respiratory muscle strength (Maximal Inspiratory Pressure \> 60% predicted)
• Whether or not submitted to Percutaneous Transluminal Coronary Angioplasty (PTCA)
• Presence of expiratory flow limitation by incremental cardiopulmonary test
• Agreement to participate in the study after reading and signing the informed consent
• Body Mass Index (BMI) ≥ 35 kg / m2
• Previous diagnosis of any musculoskeletal, neurological, respiratory or vascular diseases
• Ankle Brachial Index (ABI) \< 0.90 and \> 1.4
• Diabetes mellitus
• Active or smoking cessation for less than six months
• Chronic organic dysfunction such as renal or hepatic impairment
• Patients submitted to Coronary Artery Bypass Graft Surgery (CABG)

You may not qualify if:

• Refusal to participate in the study
• Participants who do not complete all the steps proposed in the research

Sponsors & Collaborators

• Federal University of Uberlandia: lead
• Universidade Federal de Sao Carlos: collaborator

Study Sites (1)

Universidade Federal de Uberlândia

Uberlândia, Minas Gerais, 38400-902, Brazil

Location

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MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Debora LZ Scheucher, M.S.

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 54 patients will be included, divided into three groups with 18 participants each. All will be submitted to several exams applied to the monitoring of cardiac and pulmonary function. 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.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 20, 2017
• Study Start: July 4, 2019
• Primary Completion: February 28, 2021
• Study Completion: October 31, 2022
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)