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Completed

NCT Number: NCT03560713

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.

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Key information

Conditions

Muscle Wasting Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isabella Martins de Albuquerque

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: FES sham + combined exercise

Primary outcomes

  1. Muscle thickness of the quadriceps femoris

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

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

Secondary outcomes

  1. Vastus intermedius, rectus femoris echo intensity

    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

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

  2. Rectus femoris cross-sectional area

    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 cross-sectional area will be assessed by ultrasonography

  3. Rectus femoris and vastus intermedius thickness

    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

    Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography

  4. Ankle-brachial index

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

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

  5. Peripheral muscle strength of the lower limbs

    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 will be measured by sit-to-stand test (STST).

  6. Peripheral muscle strength of the lower limbs

    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

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

  7. Quality of life

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

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

  8. Lower-limb functional exercise capacity

    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

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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Maria

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 18, 2018
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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