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

Primary Purpose

Muscle Wasting

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Functional Electrical Stimulation (FES)
Functional Electrical Stimulation (FES) sham
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Wasting

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Isabella Martins de Albuquerque

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

FES + combined exercise

FES sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Vastus intermedius, rectus femoris echo intensity
Vastus intermedius, rectus femoris echo intensity will be assessed by ultrasonography (baseline and after 12 weeks)
Rectus femoris cross-sectional area
Rectus femoris cross-sectional area will be assessed by ultrasonography
Rectus femoris and vastus intermedius thickness
Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography
Ankle-brachial index
Ankle-brachial index will be assessed by by Doppler ultrasonography using color Doppler.
Peripheral muscle strength of the lower limbs
Peripheral muscle strength of the lower limbs will be measured by sit-to-stand test (STST).
Peripheral muscle strength of the lower limbs
Peripheral muscle strength of the lower limbs will be measured by one-repetition maximum muscle strength.
Quality of life
Quality of life will be measured by a MacNew Heart Disease health-related quality of life instrument
Lower-limb functional exercise capacity
Lower-limb functional exercise capacity will be assessed by six-minute walk test

Full Information

First Posted
May 24, 2018
Last Updated
March 23, 2020
Sponsor
Universidade Federal de Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT03560713
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Wasting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES + combined exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
FES sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Functional Electrical Stimulation (FES)
Other Intervention Name(s)
FES + combined exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Functional Electrical Stimulation (FES) sham
Other Intervention Name(s)
FES sham + combined exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle thickness of the quadriceps femoris
Description
Muscle thickness of the quadriceps femoris will be assessed by ultrasonography (baseline and after 12 weeks)
Time Frame
Change in muscle thickness (in cm) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
Secondary Outcome Measure Information:
Title
Vastus intermedius, rectus femoris echo intensity
Description
Vastus intermedius, rectus femoris echo intensity will be assessed by ultrasonography (baseline and after 12 weeks)
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
Title
Rectus femoris cross-sectional area
Description
Rectus femoris cross-sectional area will be assessed by ultrasonography
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
Title
Rectus femoris and vastus intermedius thickness
Description
Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography
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
Title
Ankle-brachial index
Description
Ankle-brachial index will be assessed by by Doppler ultrasonography using color Doppler.
Time Frame
Change in ankle-brachial index (in mmHg) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
Title
Peripheral muscle strength of the lower limbs
Description
Peripheral muscle strength of the lower limbs will be measured by sit-to-stand test (STST).
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
Title
Peripheral muscle strength of the lower limbs
Description
Peripheral muscle strength of the lower limbs will be measured by one-repetition maximum muscle strength.
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
Title
Quality of life
Description
Quality of life will be measured by a MacNew Heart Disease health-related quality of life instrument
Time Frame
Change in MacNew scores from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
Title
Lower-limb functional exercise capacity
Description
Lower-limb functional exercise capacity will be assessed by six-minute walk test
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Isabella Martins de Albuquerque
City
Santa Maria
State/Province
RS
ZIP/Postal Code
97.060-330
Country
Brazil

12. IPD Sharing Statement

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

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