Effects of Functional Electrical Stimulation in Patients Undergoing Coronary Artery Bypass Grafting Surgery

Universidade Federal de Santa Maria25 enrolled

Overview

Even with major advances in clinical therapy and percutaneous interventions, coronary artery bypass grafting (CABG) is the most common cardiac surgery performed worldwide and is an effective treatment in reducing symptoms and mortality in patients with coronary artery disease (CAD). However, CABG is a complex procedure that triggers a series of clinical and functional complications, such as series postoperative repercussions as muscle wasting in the first four hours after surgery. For quantification of changes in muscle structure and morphology ultrasonography has been used. In this context, cardiac rehabilitation program (CRP) is an essential component of care in CABG patients, because this intervention can prevent muscle weakness and wasting. Among different treatment modalities, functional electrical stimulation (FES) is a feasible therapy for neuromuscular activation and prevent muscle weakness and wasting in patients in phase I CRP, however the effect of this intervention in phase II CRP not been fully elucidated. The purpose of this study will to assess the effects of FES plus combined aerobic and resistance training on muscle thickness of quadriceps femoris, lower limbs muscle strength, functional capacity, QoL in in CABG patients enrolled in a phase II CR program.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Muscle Wasting

Functional Electrical Stimulation (FES)DEVICE

Participants will perform 12 weeks of FES (Neurodyn High Volt, IBRAMED, São Paulo/SP, Brasil), three times a week, frequency 25Hz, pulse rate of 200μs, ON:OFF 5:5, individual maximum tolerated intensity; minimum at strong but comfortable visible muscle contraction (without causing undue pain or discomfort to the participant). during 30 minutes nd receive aerobic exercise training and resistance exercises for upper limbs and lower limbs.

Functional Electrical Stimulation (FES) shamOTHER

Participants will perform 12 weeks of Functional Electrical Stimulation (FES) sham (Neurodyn High Volt, IBRAMED, São Paulo/SP, Brasil), three times a week, frequency 5Hz, pulse rate of 200μs, ON:OFF 5:5, without muscle contraction during 30 minutes nd receive aerobic exercise training and resistance exercises for upper limbs and lower limbs.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients undergoing CABG up to three weeks before the initiation of the study, a clinical course without complications during hospitalization * Clinically stable * The absence of smoking (previous or current). Exclusion Criteria: * Unstable angina * Myocardial infarction and heart surgery up to three months before the survey * Chronic respiratory diseases * Hemodynamic instability * Orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and Cardiac Rehabilitation exercises * Psychological and/or cognitive impairment that restrict them to respond to questionnaires * Changes of skin sensitivity,skin lesion and allergic skin problems * Severe lymphedema * Uncontrolled diabetes mellitus * Acute superficial venous thrombophlebitis * Systemic arterial hypertension

Outcomes

Primary Outcomes

Muscle thickness of the quadriceps femoris

Muscle thickness of the quadriceps femoris will be assessed by ultrasonography (baseline and after 12 weeks)

Time frame: Change in muscle thickness (in cm) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months

Secondary Outcomes

Vastus intermedius, rectus femoris echo intensity

Vastus intermedius, rectus femoris echo intensity will be assessed by ultrasonography (baseline and after 12 weeks)

Time frame: Change in vastus intermedius and rectus femoris echo intensity (in region of interest -ROI) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months

Rectus femoris cross-sectional area

Rectus femoris cross-sectional area will be assessed by ultrasonography

Time frame: Change in rectus femoris cross-sectional area (in cm2) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months

Rectus femoris and vastus intermedius thickness

Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography

Time frame: Change in rectus femoris and vastus intermedius thickness (in cm) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months

Ankle-brachial index

Ankle-brachial index will be assessed by by Doppler ultrasonography using color Doppler.

Time frame: Change in ankle-brachial index (in mmHg) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months

Peripheral muscle strength of the lower limbs

Peripheral muscle strength of the lower limbs will be measured by sit-to-stand test (STST).

Time frame: Change in peripheral muscle strength (in number of repetitions performed in the STST) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months

Peripheral muscle strength of the lower limbs

Peripheral muscle strength of the lower limbs will be measured by one-repetition maximum muscle strength.

Time frame: Change in peripheral muscle strength (in the maximum load (kg) lifted up during the one-repetition maximum test ) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months

Quality of life

Quality of life will be measured by a MacNew Heart Disease health-related quality of life instrument

Time frame: Change in MacNew scores from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months

Lower-limb functional exercise capacity

Lower-limb functional exercise capacity will be assessed by six-minute walk test

Time frame: Change in distance walked (meters) by the patients during six-minute walk test from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months