Clinical trial NCT03560713: Effects of Functional Electrical Stimulation in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Official title: Effects of Functional Electrical Stimulation in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Wasting
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 25
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle thickness of the quadriceps femoris
timeFrame: Change in muscle thickness (in cm) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
Secondary outcomes:
measure: Vastus intermedius, rectus femoris echo intensity
timeFrame: 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
measure: Rectus femoris cross-sectional area
timeFrame: Change in rectus femoris cross-sectional area (in cm2) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
measure: Rectus femoris and vastus intermedius thickness
timeFrame: 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
measure: Ankle-brachial index
timeFrame: Change in ankle-brachial index (in mmHg) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
measure: Peripheral muscle strength of the lower limbs
timeFrame: 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
measure: Peripheral muscle strength of the lower limbs
timeFrame: 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
measure: Quality of life
timeFrame: Change in MacNew scores from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
measure: Lower-limb functional exercise capacity
timeFrame: 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
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Isabella Martins de Albuquerque
state: RS
Study officials:
References: