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

NCT03560713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-03-25

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Universidade Federal de Santa Maria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-12-20
Completion
2020-03-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03560713 on ClinicalTrials.gov