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

NCT03560713 | Completed DMC

• 1 other identifier: 85774518.3.0000.5346
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Vastus intermedius, rectus femoris echo intensity

  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

  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

  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

  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

  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

Study Arms (2)

FES + combined exercise

EXPERIMENTAL

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)

FES sham

SHAM COMPARATOR

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

Interventions

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.

Also known as: FES + combined exercise

FES + combined exercise

Functional Electrical Stimulation (FES) sham 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.

Also known as: FES sham + combined exercise

FES sham

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically stable
• The absence of smoking (previous or current).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Isabella Martins de Albuquerque

Santa Maria, Rio Grande do Sul, 97.060-330, Brazil

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

proto-oncogene protein c-fes-fps; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor DSc

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 18, 2018
• Study Start: July 1, 2017
• Primary Completion: December 20, 2019
• Study Completion: March 10, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

BR (1)