Optimization of Interval Exercise Based-intensity on Ventilatory Anaerobic Threshold in Coronary Artery Disease

NCT02313831 | Unknown DMC

• 1 other identifier: 34/2012
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of interval training, based-intensity on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic profile in patients with and without coronary artery disease.

Conditions

Coronary Artery Disease; Cardiovascular Risk Factors

Keywords

autonomic nervous system; ventilatory anaerobic threshold; oxygen consumption; metabolic profile; exercise training; expiratory flow limitation

Outcome Measures

Primary Outcomes (1)

• Intensity of interval training

  The IT intensity levels will be prescribed based on workload (W) attained at ventilatory anaerobic threshold, i. e., at 70%, 80%, 100% and 110%

  40 min

Secondary Outcomes (4)

• Aerobic functional capacity

  baseline and after interval training period (16 weeks)

• Autonomic modulation of heart rate

  baseline and after interval training period (16 weeks)

• Metabolic profile

  baseline and after interval training period (16 weeks)

• Expiratory flow limitation

  Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload

Study Arms (1)

Exercise training

EXPERIMENTAL

Patients of this group will be submitted to an interval training

Other: Interval training

Interventions

Interval training OTHER

Patients of this group will be submitted to an interval training program

Also known as: Cardiac rehabilitation

Exercise training

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients will be undergone a medical investigation for coronary artery disease, by coronary angiography, at the Hemodynamics Center of local Hospital.
• After this procedure, the CAD+ group will include 34 patients, who will have clinical evidence significant stenosis (\<50% of stenosis in one or more major coronary vessels), or previous coronary artery intervention (such as percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery).
• The CAD- group will be comprised 32 patients without stenosis in coronary vessels (angiographically documented) and without history of previous myocardial infarction (MI), PCI or CABG.
• All the patients will have three or more cardiovascular risk factors such as obesity (body mass index \>30 kg/m2), smoking, sedentary lifestyle according to the International Physical Activity Questionnaire (IPAQ) version 6, hypertension, diabetes mellitus (type 2 - nonusers of insulin), and dyslipidemia.

You may not qualify if:

• Severe cardiac arrhythmias
• Chronic obstructive pulmonary disease
• Unstable angina
• Osteomuscular disorders
• Diabetes mellitus (users of insulin)
• Renal failure
• Sequelae associated with stroke.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Nayara Yamada Tamburús

São Carlos, São Paulo, 13.566-620, Brazil

RECRUITING

Related Publications (2)

• Tamburus NY, Verlengia R, Kunz VC, Cesar MC, Silva E. Apolipoprotein B and angiotensin-converting enzyme polymorphisms and aerobic interval training: randomized controlled trial in coronary artery disease patients. Braz J Med Biol Res. 2018;51(8):e6944. doi: 10.1590/1414-431x20186944. Epub 2018 May 28.

  PMID: 29846435 DERIVED

• Tamburus NY, Kunz VC, Salviati MR, Castello Simoes V, Catai AM, Da Silva E. Interval training based on ventilatory anaerobic threshold improves aerobic functional capacity and metabolic profile: a randomized controlled trial in coronary artery disease patients. Eur J Phys Rehabil Med. 2016 Feb;52(1):1-11. Epub 2015 Jun 18.

  PMID: 26086326 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

High-Intensity Interval Training; Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ester d Silva, PhD

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayara Y Tamburus, M.D.

CONTACT

+5519998821224; nayaratamburus@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

BR (1)