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Clinical Trials/NCT02265107
NCT02265107CompletedNot Applicable

Effects of Exercise Training on Vascular Endothelial Function of Patients Submitted to Coronary Artery Bypass Graft

Universidade Federal do Rio Grande (FURG)2 sites in 1 country9 target enrollmentStarted: March 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
9
Locations
2
Primary Endpoint
Vascular endothelial function

Study Overview

Brief Summary

Objective: To observe the effects of exercise training on vascular endothelial function in patients undergoing coronary artery bypass graft (CABG) alone in phase III after six months of Cardiac rehabilitation programs (CRP).

Methods: the investigators contacted all patients undergoing CABG alone in period of 1 year to participate in a CRP with duration of six months with three weekly sessions of 1 and half hour of the duration. All patients underwent biochemical blood tests, muscle strength testing of one repetition maximum (1-RM test) for upper and lower limbs, 6-minute walk test (6MWT), and evaluation of endothelial function (using flow-mediated vasodilation).

Detailed Description

Introduction The cardiac rehabilitation optimizes a cardiac patient's physical, psychological, and social functioning, in addition to stabilizing, slowing, or even reversing the progression of the underlying atherosclerotic processes, thereby reducing morbidity and mortality. Patients who recently had had a myocardial infarction; or had undergone coronary artery bypass graft; or who had undergone percutaneous coronary interventions; or who are heart transplantation candidates or recipients; or have stable chronic heart failure, peripheral arterial disease with claudication, or other forms of CVD are candidates eligible for cardiac rehabilitation services ( , ).

Recently, studies randomized clinical trials have reported the efficacy of the exercise training (ET) independently of format of exercise: aerobic, resistance, or combined exercise training in patients with coronary artery disease ( , ) and, others studies investigated the effects of ET on vascular endothelial function in patients with stable coronary artery disease ( ), ischemic heart disease ( ), recent myocardial infarction (4), and chronic heart failure (3, , ). ET is associated with an improvement in endothelial function, oxidative stress, and inflammation. Furthermore, the ET promotes beneficial effects on cardiovascular outcomes and decreases hospitalizations.

Arterial endothelium function evaluated by flow-mediated vasodilation (FMD) is a predictor of long-term adverse cardiovascular outcomes in healthy subjects ( ). Vascular endothelial dysfunction is an independent risk factor for cardiovascular events and provides important prognostic data in addition to the more traditional risk factors ( ). Endothelial dysfunction plays an important role in patients with coronary atherosclerosis (both acute and chronic myocardial ischemia) and heart failure (3,5, ). Therefore, we aim to investigate the effect of combined exercise training on vascular endothelial function in sedentary patients submitted to coronary artery bypass graft (CABG) in late phase.

Methods The protocol was approved by the local ethics committee of Associação de Caridade Santa Casa do Rio Grande Hospital, Rio Grande/RS - Brazil, under the protocol number 003/2013. This study was non-randomized clinical trial. The written informed consent was obtained from all patients before of the onset of ET. The investigators invited all consecutive patients submitted to CABG alone at Cardiologic Hospital Doctor Pedro Bertoni of the Associação de Caridade Santa Casa do Rio Grande in the period of October, 2011 until October, 2012, who resided in the city of the Rio Grande (RS/Brazil), to participate of the ET. The investigators excluded the patients that performed others cardiologic procedures with the CABG. All patients were evaluated by cardiologist, and were ranked in Functional Classification of New York Heart Association (NYHA) such class I and II. Initially, twenty-four patients accepted and start to participate of ET, but only nine patients completed the program until the end.

The program of exercise training (ET) was employed for 6 consecutive months with 3 sessions per week. The training of physical activity consisted of a combination of aerobic and resistance exercises for upper and lower limbs. Each session included: (1) 5-minute warm-up, (2) 30 minutes of aerobic exercise (performed in treadmills and stationary bikes); (3) 20 minutes of resistance exercises with dumbbells for upper limbs and ankle support for lower limbs (exercises preformed in diagonals) that consisted of 6 sets of 10 resistance exercises repeated for upper limbs, and the same number of sets for lower limbs; and (4) 5-minute cool-down, totaling ninety minutes of session per day (90min/day) and, two hundred and seventy minutes per week (270min/week) ( ). Initialy, in aerobic exercises, the maximal HR to be achieved was established between 30-40% of HR at rest and, the aerobic exercise was limited by symptoms reported by patients. The initial weight of the dumbbells and ankle were established between 30-40% of one-repetition maximum test (1-RM test) and, gradually increased according to the symptoms reported by patients, without compensation of the trunk to perform the exercises, no history of muscle pain, and no muscle fatigue to complete all sessions. Heart rate (HR), respiratory rate (RR), saturation pulse of oxygen, and blood pressure were measured at the beginning, middle and end of each session. The intensity and the velocity of the exercise program were progressively increased.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • resided in the city of the Rio Grande (RS/Brazil);
  • age over 18 years-old;
  • evaluation and medical authorization.

Exclusion Criteria

  • the patients that performed others cardiologic procedures with the Coronary Artery Bypass Graft

Outcomes

Primary Outcomes

Vascular endothelial function

Time Frame: after 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Priscila Aikawa

Priscila Aikawa PhD

Universidade Federal do Rio Grande (FURG)

Study Sites (2)

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