Heart FailureNCT01325597
Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients
A study testing Combined training, Electrical stimulation and Inspiratory muscle training in people with Heart Failure, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
The purpose of this study is to assess the effects of functional electrical stimulation associated with inspiratory muscle training on functional capacity and quality of life in heart failure patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Combined training, Electrical stimulation and Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Mar 2017
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable heart failure and New York Heart Association (NYHA) class II-IV
- Aged 30-70 years
- Left ventricular ejection fraction less than 35% determined by echocardiography and optimized pharmacological treatment (unchanged 1 month prior to study)
Who cannot join
- Patients with unstable heart failure
- NYHA class I
- Unstable angina pectoris and ventricular arrhythmia
- Implanted cardiac pacemaker
- Acute pulmonary diseases
- Chronic renal failure or dialysis
Show all 12Show fewer
- Acute myocardial infarction 3 months before the inclusion in the study
- Acute inflammatory diseases
- Peripheral vascular disease
- Neurologic disease
- Musculoskeletal pathologies
- Malignancies or being an active smoker
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90.620-000
Rodrigo DM Plentz, PhD, + 55 51 32192802, roplentz@yahoo.com.br
Graciele Sbruzzi, MSc, + 55 51 32232746, graci_sbruzzi@hotmail.com
About this study
Official title: Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial
The purpose of this study is to assess the effects of functional electrical stimulation associated with inspiratory muscle training on functional capacity and quality of life in heart failure patients.
Read the detailed description
The aim of this study is to assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity and quality of life in patients with heart failure (HF). A randomized clinical trial with 60 HF patients (functional class II-IV) will be randomly assigned to the FES, IMT, IMT associated with FES or control group. FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure. Acute and chronic effects of interventions on functional capacity, quality of life, peripheral muscle strength, pulmonary function, respiratory muscle strength and endurance, endothelial function, autonomic control and oxidative stress will be analyzed in these patients.
- Conditions
- Heart Failure
- Being tested
- Combined training, Electrical stimulation, Inspiratory muscle training, Control group
- Keywords
- Heart failure, Electric stimulation, Breathing exercises
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined trainingOther
Also called Electric stimulation, Electrical stimulation, Inspiratory muscle training, Breathing exercises
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure.
Electrical stimulationOther
Also called Electric stimulation, Eletric stimulation therapy
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks
Inspiratory muscle trainingOther
Also called Respiratory muscle training, Breathing exercises
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Combined training | Experimental | Training with functional electrical stimulation added by inspiratory muscle training. Receives: Other: Electrical stimulation; Other: Inspiratory muscle training; Other: Control group |
| Electrical stimulation | Experimental | FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks Receives: Other: Combined training; Other: Inspiratory muscle training; Other: Control group |
| Inspiratory muscle training | Experimental | IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure Receives: Other: Combined training; Other: Electrical stimulation; Other: Control group |
| Control group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.
Measured: 12 weeks
Secondary outcomes (7)
Quality of life
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on quality of life.
Measured: 12 weeks
Peripheral muscle strength
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on peripheral muscle strength.
Measured: 12 weeks
Pulmonary function
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary function.
Measured: 12 weeks
Respiratory muscle strength
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on respiratory muscle strength.
Measured: 12 weeks
Endothelial function
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on endothelial function.
Measured: 12 weeks
Autonomic control
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on autonomic control.
Measured: 12 weeks
Oxidative stress
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Graciele Sbruzzi, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Rodrigo DM Plentz, PhD, Principal investigator, Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325597
- Sponsor's protocol ID
- UP 4546/10
- Status last verified
- Mar 2015
- First submitted
- 14 Mar 2011
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01325597
- Acronym / sponsor ID
- UP 4546/10
- Conditions
- Heart Failure
- Keywords
- Heart failure, Electric stimulation, Breathing exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2010
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 30 Mar 2011 (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 is to assess the effects of functional electrical stimulation associated with inspiratory muscle training on functional capacity and quality of life in heart failure patients.
Detailed description
The aim of this study is to assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity and quality of life in patients with heart failure (HF). A randomized clinical trial with 60 HF patients (functional class II-IV) will be randomly assigned to the FES, IMT, IMT associated with FES or control group. FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure. Acute and chronic effects of interventions on functional capacity, quality of life, peripheral muscle strength, pulmonary function, respiratory muscle strength and endurance, endothelial function, autonomic control and oxidative stress will be analyzed in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined training | Experimental | Other: Electrical stimulation, Other: Inspiratory muscle training, Other: Control groupTraining with functional electrical stimulation added by inspiratory muscle training. |
| Electrical stimulation | Experimental | Other: Combined training, Other: Inspiratory muscle training, Other: Control groupFES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks |
| Inspiratory muscle training | Experimental | Other: Combined training, Other: Electrical stimulation, Other: Control groupIMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure |
| Control group | No intervention | –No intervention. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stable heart failure and New York Heart Association (NYHA) class II-IV
- Aged 30-70 years
- Left ventricular ejection fraction less than 35% determined by echocardiography and optimized pharmacological treatment (unchanged 1 month prior to study)
Key exclusion criteria (12 listed)
- Patients with unstable heart failure
- NYHA class I
- Unstable angina pectoris and ventricular arrhythmia
- Implanted cardiac pacemaker
- Acute pulmonary diseases
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 |
|---|---|---|
| Combined trainingAlso: Electric stimulation, Electrical stimulation, Inspiratory muscle training, Breathing exercisesFES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure. | Other | Electrical stimulation, Inspiratory muscle training |
| Electrical stimulationAlso: Electric stimulation, Eletric stimulation therapyFES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks | Other | Combined training, Inspiratory muscle training |
| Inspiratory muscle trainingAlso: Respiratory muscle training, Breathing exercisesIMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure | Other | Combined training, Electrical stimulation |
| Control groupNo intervention | Other | Combined training, Electrical stimulation, Inspiratory muscle training |
Primary outcome
Functional capacity
Time frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.
7 secondary outcomes
Quality of life
Time frame: 12 weeks
Peripheral muscle strength
Time frame: 12 weeks
Pulmonary function
Time frame: 12 weeks
Respiratory muscle strength
Time frame: 12 weeks
Endothelial function
Time frame: 12 weeks
Autonomic control
Time frame: 12 weeks
Oxidative stress
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
Rodrigo DM Plentz, PhD principal investigator
Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined training, Electrical stimulation and Inspiratory muscle training in people with Heart Failure, run by Instituto de Cardiologia do Rio Grande do Sul 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Mar 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo DM Plentz, PhD (+ 55 51 91794399, roplentz@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: 12 weeks). 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 11 Mar 2015.