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

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 Overview

• Status: Completed
• Conditions: Muscle Wasting
• Intervention / Treatment: Device: Functional Electrical Stimulation (FES); Other: Functional Electrical Stimulation (FES) sham

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Santa Maria, RS, Brazil, 97.060-330
      • Isabella Martins de Albuquerque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: FES + combined exercise
Sham Comparator: 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.	Other: 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.; Other Names: FES sham + combined exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle thickness of the quadriceps femoris	Muscle thickness of the quadriceps femoris will be assessed by ultrasonography (baseline and after 12 weeks)	Change in muscle thickness (in cm) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vastus intermedius, rectus femoris echo intensity	Vastus intermedius, rectus femoris echo intensity will be assessed by ultrasonography (baseline and after 12 weeks)	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	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	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.	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).	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.	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	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	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

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Maria

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy
• Other Study ID Numbers: 85774518.3.0000.5346

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No