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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria: Patients undergoing CABG up to three weeks before the initiation of the study, a clinical course without complications during hospitalization
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isabella Martins de Albuquerque | Santa Maria | Rio Grande do Sul | 97.060-330 | Brazil |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| C052602 | proto-oncogene protein c-fes-fps |
| C005703 | salicylhydroxamic acid |
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| 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. |
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| 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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |