Muscle WastingNCT03560713
Effects of Functional Electrical Stimulation in Patients Undergoing Coronary Artery Bypass Grafting Surgery
A study testing Functional Electrical Stimulation (FES) in people with Muscle Wasting, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Muscle Wasting
- What is being tested?
- Functional Electrical Stimulation (FES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2017to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 11Show fewer
- Changes of skin sensitivity,skin lesion and allergic skin problems
- Severe lymphedema
- Uncontrolled diabetes mellitus
- Acute superficial venous thrombophlebitis
- Systemic arterial hypertension
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Isabella Martins de Albuquerque
Santa Maria, Rio Grande do Sul, 97.060-330
About this study
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.
- Conditions
- Muscle Wasting
- Being tested
- Functional Electrical Stimulation (FES), Functional Electrical Stimulation (FES) sham
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation (FES)Device
Also called FES + combined exercise
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.
Functional Electrical Stimulation (FES) shamOther
Also called FES sham + combined exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Functional Electrical Stimulation (FES) |
| 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. Receives: Other: Functional Electrical Stimulation (FES) sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness of the quadriceps femoris
Muscle thickness of the quadriceps femoris will be assessed by ultrasonography (baseline and after 12 weeks)
Measured: Change in muscle thickness (in cm) from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
Secondary outcomes (8)
Vastus intermedius, rectus femoris echo intensity
Vastus intermedius, rectus femoris echo intensity will be assessed by ultrasonography (baseline and after 12 weeks)
Measured: 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
Rectus femoris cross-sectional area
Rectus femoris cross-sectional area will be assessed by ultrasonography
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Jul 2017
- Primary completion20 Dec 2019
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabella Martins de Albuquerque, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560713
- Sponsor's protocol ID
- 85774518.3.0000.5346
- Status last verified
- Mar 2020
- First submitted
- 24 May 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Electrical Stimulation in Patients Undergoing Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT03560713
- Acronym / sponsor ID
- 85774518.3.0000.5346
- Conditions
- Muscle Wasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES + combined exercise | Experimental | Device: Functional Electrical Stimulation (FES)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. |
| FES sham | Sham comparator | Other: Functional Electrical Stimulation (FES) shamThe 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. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical Stimulation (FES)Also: FES + combined exerciseParticipants 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. | Device | FES + combined exercise |
| Functional Electrical Stimulation (FES) shamAlso: FES sham + combined exerciseParticipants 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 | FES sham |
Primary outcome
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)
8 secondary outcomes
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
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 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
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
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
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
Quality of life
Time frame: Change in MacNew scores from baseline at after 12 weeks of rehabilitation cardiac admission, an average of 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation (FES) in people with Muscle Wasting, run by Universidade Federal de Santa Maria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.