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

NCT ID: NCT03560713

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-03-10

Brief Summary

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.

Conditions

Muscle Wasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

FES + combined exercise

The Functional Electrical Stimulation (FES) + combined exercise group will receive 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) and receive aerobic exercise training and resistance exercises for upper limbs and lower limbs.

Group Type: EXPERIMENTAL

Functional Electrical Stimulation (FES)

Intervention Type: 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.

FES sham

The Functional Electrical Stimulation (FES) sham + combined exercise group will receive 12 weeks of FES (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 and receive aerobic exercise training and resistance exercises for upper limbs and lower limbs.

Group Type: SHAM_COMPARATOR

Functional Electrical Stimulation (FES) sham

Intervention Type: OTHER

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.

Interventions

Functional Electrical Stimulation (FES)

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.

Intervention Type: DEVICE

Functional Electrical Stimulation (FES) sham

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.

Intervention Type: OTHER

Other Intervention Names

FES + combined exercise; FES sham + combined exercise

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Santa Maria

OTHER

Sponsor Role: lead

Responsible Party

Isabella Martins de Albuquerque

Professor DSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Isabella Martins de Albuquerque

Santa Maria, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

85774518.3.0000.5346

Identifier Type: -

Identifier Source: org_study_id