Coronary DiseaseNCT02088138
Functional Electrical Stimulation in Cardiac Patients
A study testing Functional Electrical Stimulation in people with Coronary Disease and Heart Failure, run by Prof. Dr. Antônio Marcos Vargas da Silva at 3 sites in Brazil.
Trial summary
The purpose of this study was to determine the effects of Functional Electrical Stimulation (FES) on physical performance and quality of life of patients in cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Coronary Disease, Heart Failure
- What is being tested?
- Functional Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesBrazil
- Study dates
- Sep 2010to Jun 2012
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in phase II and III of cardiac rehabilitation undergoing coronary artery bypass grafting or valve replacement
Who cannot join
- Patients with some cognitive impairment that prevents the completion of assessments, inability to understand the term of free and informed consent or with the following contraindications to the use of FES: epidermal lesions at the site of application, change of skin sensitivity or intolerance electrical stimulator;
- Patients undergoing cardiac surgery other than coronary artery bypass grafting or valve replacement;
- Patients who use pacemakers;
- Subjects with peripheral vascular changes in the lower limbs;
- Presence of comorbidities such as chronic obstructive pulmonary disease (COPD), cerebrovascular disease or skeletal muscle disease.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90040-060
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, 97105-900
About this study
Official title: Effects of Functional Electrical Stimulation on Physical Performance of Patients in Cardiac Rehabilitation
The purpose of this study was to determine the effects of Functional Electrical Stimulation (FES) on physical performance and quality of life of patients in cardiac rehabilitation.
Read the detailed description
This randomized controlled trial aimed to evaluate the effects of functional electrical stimulation (FES) in patients with stage II and III cardiac rehabilitation (CR) on the variables strength, endurance and muscle tropism lower limb, functional capacity and quality of life. To this were invited to participate in the study cardiac patients registered in the database of the cardiology department of the University Hospital of Santa Maria. The sample included patients of both sexes undergoing coronary artery bypass grafting or valve replacement. The subjects were divided into two groups: placebo group (PG) or functional electrical stimulation group (FESG). To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: one repetition maximum test, sit-and-stand test, perimetry thighs, the six-minute walk test and evaluate the quality of life through The Medical questionnaire Study 36-item Short-Form Health Survey (SF-36).
- Conditions
- Coronary Disease, Heart Failure
- Being tested
- Functional Electrical Stimulation, Functional Electrical Stimulation placebo
- Keywords
- Thoracic Surgery, Electrical Stimulation, Rehabilitation, Quality of Life
- Medical subject headings
- Coronary Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationDevice
Also called FES
Functional electrical stimulation twice per week for eight weeks totaling sixteen sessions.
Functional Electrical Stimulation placeboDevice
Also called FES placebo
Functional electrical stimulation in the sensory threshold level, twice a week for eight weeks, totaling sixteen sessions.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation | Experimental | Functional Electrical Stimulation
In the intervention group the FES was applied in the medial and lateral vastus of both thighs targeting the movement of knee extension. The application frequency was 15 Hz, lasting 40 minutes, pulse width of 0.5 ms, time ON 5s, time OFF 10s, ramp-up of 0 or 1s, descent ramp 2s and intensity as tolerance patient. Receives: Device: Functional Electrical Stimulation |
| FES placebo | Experimental | Functional Electrical Stimulation placebo
The placebo group received functional electrical stimulation with the same parameters in the intervention group, except that the intensity of stimulation did not lead to visible or palpable contraction. Receives: Device: Functional Electrical Stimulation placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance on the six minute walk test
Measured: Two Years
Secondary outcomes (4)
Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test
Measured: Two years
Quality of life through The Medical Study 36-Item Short-Form Health Survey (SF-36) questionnaire
Measured: Two years
Lower limb muscle tropism evaluated by measuring the thigh circumference by tape
Measured: Two years
Lower limb muscle endurance assessed by sit-and-stand test
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Antônio Marcos Vargas da Silva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria
- Investigators
- Antônio M Vargas da Silva, PhD, Principal investigator, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088138
- Sponsor's protocol ID
- FESCP01
- Status last verified
- Mar 2014
- First submitted
- 26 Feb 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Electrical Stimulation on Physical Performance of Patients in Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT02088138
- Acronym / sponsor ID
- FESCP01
- Conditions
- Coronary Disease, Heart Failure
- Keywords
- Thoracic Surgery, Electrical Stimulation, Rehabilitation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Prof. Dr. Antônio Marcos Vargas da SilvaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Mar 2014 (estimated)
- 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.
The purpose of this study was to determine the effects of Functional Electrical Stimulation (FES) on physical performance and quality of life of patients in cardiac rehabilitation.
Detailed description
This randomized controlled trial aimed to evaluate the effects of functional electrical stimulation (FES) in patients with stage II and III cardiac rehabilitation (CR) on the variables strength, endurance and muscle tropism lower limb, functional capacity and quality of life. To this were invited to participate in the study cardiac patients registered in the database of the cardiology department of the University Hospital of Santa Maria. The sample included patients of both sexes undergoing coronary artery bypass grafting or valve replacement. The subjects were divided into two groups: placebo group (PG) or functional electrical stimulation group (FESG). To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: one repetition maximum test, sit-and-stand test, perimetry thighs, the six-minute walk test and evaluate the quality of life through The Medical questionnaire Study 36-item Short-Form Health Survey (SF-36).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation | Experimental | Device: Functional Electrical StimulationFunctional Electrical Stimulation In the intervention group the FES was applied in the medial and lateral vastus of both thighs targeting the movement of knee extension. The application frequency was 15 Hz, lasting 40 minutes, pulse width of 0.5 ms, time ON 5s, time OFF 10s, ramp-up of 0 or 1s, descent ramp 2s and intensity as tolerance patient. |
| FES placebo | Experimental | Device: Functional Electrical Stimulation placeboFunctional Electrical Stimulation placebo The placebo group received functional electrical stimulation with the same parameters in the intervention group, except that the intensity of stimulation did not lead to visible or palpable contraction. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in phase II and III of cardiac rehabilitation undergoing coronary artery bypass grafting or valve replacement
Key exclusion criteria (5 listed)
- Patients with some cognitive impairment that prevents the completion of assessments, inability to understand the term of free and informed consent or with the following contraindications to the use of FES: epidermal lesions at the site of application, change of skin sensitivity or intolerance electrical stimulator;
- Patients undergoing cardiac surgery other than coronary artery bypass grafting or valve replacement;
- Patients who use pacemakers;
- Subjects with peripheral vascular changes in the lower limbs;
- Presence of comorbidities such as chronic obstructive pulmonary disease (COPD), cerebrovascular disease or skeletal muscle disease.
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 StimulationAlso: FESFunctional electrical stimulation twice per week for eight weeks totaling sixteen sessions. | Device | Functional Electrical Stimulation |
| Functional Electrical Stimulation placeboAlso: FES placeboFunctional electrical stimulation in the sensory threshold level, twice a week for eight weeks, totaling sixteen sessions. | Device | FES placebo |
Primary outcome
Distance on the six minute walk test
Time frame: Two Years
4 secondary outcomes
Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test
Time frame: Two years
Quality of life through The Medical Study 36-Item Short-Form Health Survey (SF-36) questionnaire
Time frame: Two years
Lower limb muscle tropism evaluated by measuring the thigh circumference by tape
Time frame: Two years
Lower limb muscle endurance assessed by sit-and-stand test
Time frame: Two years
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 14 Mar 2014.
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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.
Antônio M Vargas da Silva, PhD principal investigator
Universidade Federal de Santa Maria
3 sites 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 in people with Coronary Disease and Heart Failure, run by Prof. Dr. Antônio Marcos Vargas da Silva at 3 sites 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 1 inclusion and 5 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 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Distance on the six minute walk test (time frame: Two Years). 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 14 Mar 2014.