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

Muscle Wasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560713
• Other study ID #: 85774518.3.0000.5346
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: March 10, 2020

Study information

• Verified date: March 2020
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 10, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Wasting
• Muscular Atrophy

Intervention

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.

Locations

Country	Name	City	State
Brazil	Isabella Martins de Albuquerque	Santa Maria	RS

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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