Chronic Heart FailureNCT02794935
The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome
A study testing Inspiratory muscle training (IMT) in people with Chronic Heart Failure, run by University of Cruz Alta at 1 site in Brazil.
Trial summary
This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in patients with heart failure and obstructive sleep apnea… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Inspiratory muscle training (IMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Dec 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
- Heart failure patients with obstructive sleep apnea- hypopnea
- Heart failure patients without sleep apnea
- Left ventricle fraction ejection < 51 % for men and < 53% for woman
- Must be clinically stable
- New York Heart Association I, II and III
- Without changes in medication for the last three months.
Who cannot join
- Unstable angina
- Atrial fibrillation
- Acute myocardial infarction (<6 months)
- Recent heart surgery (<6 months)
- Chronic metabolic disease
- Infectious disease
Show all 14Show fewer
- Anemia
- Severe hypoxemia
- Neuromuscular disease
- Diabetes mellitus
- Obesity
- Use of continuous positive airway pressure
- Smoking
- Pulmonary disease (forced vital capacity <80% of predicted and / or forced expiratory volume in one second <70% predicted).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Cruz Alta
Cruz Alta, Rio Grande do Sul, 9800050
Carine C Callegaro, ccallegaro@unicruz.edu.br
About this study
This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in patients with heart failure and obstructive sleep apnea syndrome.
Read the detailed description
Patients with heart failure will be selected through the Outpatient of the Rio Grande do Sul, for convenience. Subsequently, patients will be subjected to test respiratory muscle strength (manometer), respiratory muscle endurance, portable polysomnography, sleepiness, sleep quality, cognitive function (mini-mental state examination), motor task (execution of a sequence of digital movements), executive function, quality of life (SF-36), maximum exercise testing, chemoreflex sensitivity (peripheral chemoreflex by transient hypoxia and central chemoreflex by hypercapnic hyperoxia) and vagal modulation of heart rate (spectral analysis) before the start of the training protocol. Patients will be randomized to inspiratory muscle training or control group. Inspiratory muscle training will be performed for 30 minutes a day, 7 days a week, for 12 weeks with muscle training device (PowerBreathe). There will be a weekly monitoring in the Clinical Research Center of the institution where the maximal inspiratory pressure (MIP) and respiratory training techniques will be reassessed and readjusted (30% of MIP). The control group will be submitted to respiratory training techniques with muscle training device (PowerBreathe) without load. After this period, all initial tests will be reassessed. A group study with 15 heart failure patients without obstructive sleep apnea syndrome will be included.
- Conditions
- Chronic Heart Failure
- Being tested
- Inspiratory muscle training (IMT), Sham IMT
- Keywords
- inspiratory muscle training, heart failure, obstructive sleep apnea
- Medical subject headings
- Heart Failure, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training (IMT)Other
Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
Sham IMTOther
Participants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training (IMT) | Experimental | Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center. Receives: Other: Inspiratory muscle training (IMT) |
| Sham IMT | Placebo comparator | Participants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center. Receives: Other: Sham IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index
measured by portable polysomnography [in events/hour]
Measured: 12 weeks
Secondary outcomes (9)
sleepiness
measured by Epworth Sleepiness Scale [in score]
Measured: 12 weeks
sleep quality
assessed by the Pittsburgh sleep quality index [in score]
Measured: 12 weeks
cognitive function
measured by the mini-mental state [in points]
Measured: 12 weeks
motor task
assessed by the execution of a sequence of digital movements [in time required and number of execution errors]
Measured: 12 weeks
executive function measured by Trail Making Test
measured by Trail Making Test. In Part A, participants are asked to link numbered points randomly distributed on a sheet of paper in ascending order according to numbers. In Part B, the participants are asked to link numbers and letters alternately [in time of test performance, counts the number of errors, and calculates the difference in times: B-A.].
Measured: 12 weeks
quality of life assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)
assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)
Measured: 12 weeks
peak oxygen consumption
It will be assessed using of treadmill stress test with Bruce protocol. The peak oxygen consumption will be estimated according to the method established by the American College Sports Medicine [in mL.kg-1.min-1]
Measured: 12 weeks
chemoreflex sensitivity
peripheral chemoreflex will be assessed by transient hypoxia [in L.min-1.mmHg] and central chemoreflex by hypercapnic hyperoxic in [L. min-1. %SatO2]
Measured: 12 weeks
vagal modulation measured by heart rate monitoring in the time domain (spectral analysis)
measured by heart rate monitoring in the time domain by spectral analysis [in normalized units]
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 posted9 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cruz Alta
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Carine C Callegaro, PhD, Principal investigator, University of Cruz Alta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794935
- Sponsor's protocol ID
- CAAE: 25471413.7.0000.5322
- Status last verified
- Aug 2016
- First submitted
- 31 May 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The volunteers will receive the results of the evaluations pre and post-intervention by the of the study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT02794935
- Acronym / sponsor ID
- CAAE: 25471413.7.0000.5322
- Conditions
- Chronic Heart Failure
- Keywords
- inspiratory muscle training, heart failure, obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Cruz AltaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Jun 2016 (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.
This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in patients with heart failure and obstructive sleep apnea syndrome.
Detailed description
Patients with heart failure will be selected through the Outpatient of the Rio Grande do Sul, for convenience. Subsequently, patients will be subjected to test respiratory muscle strength (manometer), respiratory muscle endurance, portable polysomnography, sleepiness, sleep quality, cognitive function (mini-mental state examination), motor task (execution of a sequence of digital movements), executive function, quality of life (SF-36), maximum exercise testing, chemoreflex sensitivity (peripheral chemoreflex by transient hypoxia and central chemoreflex by hypercapnic hyperoxia) and vagal modulation of heart rate (spectral analysis) before the start of the training protocol. Patients will be randomized to inspiratory muscle training or control group. Inspiratory muscle training will be performed for 30 minutes a day, 7 days a week, for 12 weeks with muscle training device (PowerBreathe). There will be a weekly monitoring in the Clinical Research Center of the institution where the maximal inspiratory pressure (MIP) and respiratory training techniques will be reassessed and readjusted (30% of MIP). The control group will be submitted to respiratory training techniques with muscle training device (PowerBreathe) without load. After this period, all initial tests will be reassessed. A group study with 15 heart failure patients without obstructive sleep apnea syndrome will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training (IMT) | Experimental | Other: Inspiratory muscle training (IMT)Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center. |
| Sham IMT | Placebo comparator | Other: Sham IMTParticipants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Heart failure patients with obstructive sleep apnea- hypopnea
- Heart failure patients without sleep apnea
- Left ventricle fraction ejection < 51 % for men and < 53% for woman
- Must be clinically stable
- New York Heart Association I, II and III
Key exclusion criteria (14 listed)
- Unstable angina
- Atrial fibrillation
- Acute myocardial infarction (<6 months)
- Recent heart surgery (<6 months)
- Chronic metabolic 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 |
|---|---|---|
| Inspiratory muscle training (IMT)Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center. | Other | Inspiratory muscle training (IMT) |
| Sham IMTParticipants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center | Other | Sham IMT |
Primary outcome
Apnea hypopnea index
Time frame: 12 weeks
measured by portable polysomnography [in events/hour]
9 secondary outcomes
sleepiness
Time frame: 12 weeks
sleep quality
Time frame: 12 weeks
cognitive function
Time frame: 12 weeks
motor task
Time frame: 12 weeks
executive function measured by Trail Making Test
Time frame: 12 weeks
quality of life assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)
Time frame: 12 weeks
peak oxygen consumption
Time frame: 12 weeks
chemoreflex sensitivity
Time frame: 12 weeks
vagal modulation measured by heart rate monitoring in the time domain (spectral analysis)
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 9 Aug 2016.
- Individual participant dataSharing planned: Yes. The volunteers will receive the results of the evaluations pre and post-intervention by the of the study.
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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.
Carine C Callegaro, PhD principal investigator
University of Cruz Alta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training (IMT) in people with Chronic Heart Failure, run by University of Cruz Alta 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 6 inclusion and 14 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 9 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carine C Callegaro, PhD (55 55 9914-6712, ccallegaro@unicruz.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea hypopnea index (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 9 Aug 2016.