Chronic Heart FailureINCANCT01606553
Inspiratory Muscle Training in Patients With Chronic Heart Failure
A study testing High-intensity IMT in people with Chronic Heart Failure, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether a high intensity short duration inspiratory muscle training is feasible, secure and effective to improve respiratory muscle function (strength and resistance), health-related quality of life, and to assess potential correlations with health resources utilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- High-intensity IMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years;
- chronic heart failure (CHF) of any etiology;
- clinically stable condition, with no worsening of heart failure or change in cardiac medication in the previous 3 months and during the study; and
- ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
Who cannot join
- previous history of any chronic respiratory disease;
- not to have performed any kind of general or respiratory training in the previous 3 months.
- Prior to randomization, all patients' clinical assessment and echocardiographic measurements were done by a cardiologist and all patients underwent pulmonary function tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The INCA Study: Inspiratory Muscle Training in Patients With Chronic Heart Failure
The purpose of this study is to determine whether a high intensity short duration inspiratory muscle training is feasible, secure and effective to improve respiratory muscle function (strength and resistance), health-related quality of life, and to assess potential correlations with health resources utilization.
Read the detailed description
Patients with chronic heart failure (CHF) often refer exercise intolerance, marked fatigue and dyspnea at low exercise intensities. This characteristic feature might be generated by respiratory and skeletal muscle dysfunction, and it´s has been described as a comorbid status, reflecting the systemic impact of heart failure. Despite the availability of effective pharmacologic treatments, patients with CHF continue to experience progressively worsening symptoms, frequent hospital admission and premature death. Reduced physical functioning, role limitation, and lack of energy may interfere with daily activities as the condition worsens and thereby severely reduce the quality of life in CHF patients. The ACCF/AHA Guidelines for the diagnosis and management of heart failure recommend exercise training as an adjunctive approach to improve clinical status in stable adult patients with current or prior symptoms of heart failure and reduced left ventricular ejection fraction. A wide variety of studies have focussed on respiratory muscles abnormalities in CHF patients. Reduced strength and endurance of respiratory muscles are currently recognized as additional factors implicated in the limited exercise response and quality of life, as well as in a poor prognosis. Additionally, inspiratory muscle training (IMT) has shown to result in improvements on inspiratory strength, functional capacity, ventilatory response to exercise, recovery oxygen uptake kinetics, and quality of life of CHF patients with respiratory muscle weakness. The optimal training scheme remains still to be defined. Most of clinical trials have demonstrated the effectiveness of a low-intensity IMT (maximum 38 cmH2O), but there is little information of the training effects when using higher training loads. Our research group has demonstrated that a short-time high-intensity respiratory training in patients with chronic obstructive pulmonary disease afford to reach good functional results in a shorter time, which affords to make more efficient in terms of time the rehabilitation program and to reach to more patients.
- Conditions
- Chronic Heart Failure
- Being tested
- High-intensity IMT, Sham High-intensity IMT
- Keywords
- chronic heart failure, respiratory muscle weakness, inspiratory muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity IMTDevice
Also called Orygen-Dual valve prototype
High intensity short duration respiratory muscle training with a valve prototype
Sham High-intensity IMTDevice
Also called Sham Orygen-Dual valve prototype
High intensity short duration respiratory muscle training using a sham valve prototype
| Study group | Role | What they receive |
|---|---|---|
| High-intensity IMT | Experimental | High intensity short duration respiratory muscle training (IMT) using a dual-vave prototype Receives: Device: High-intensity IMT |
| Sham High-intensity IMT | Active comparator | High intensity short duration respiratory muscle training (IMT) using a sham dual-vave prototype Receives: Device: Sham High-intensity IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory muscle function strength
Transducer measuring maximal inspiratory and expiratory pressures
Measured: Baseline to 4 weeks
Secondary outcomes (3)
Change in health-related quality of life
Minnesotta Living wih Heart Failure Questionnaire and Short Form 36
Measured: Baseline to 4 weeks
Adverse effects from training
Adverse events collection by investigator
Measured: Baseline to week 4
Health care utilization
Hospital admissions and emergency room visits
Measured: Baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Marco Navarro, Parc de Salut Mar
- Investigators
- Ferran Escalada, MD, PhD, Study director, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606553
- Sponsor's protocol ID
- INCA
- Acronym
- INCA
- Status last verified
- Feb 2016
- First submitted
- 21 May 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Marco E, Ramirez-Sarmiento AL, Coloma A, Sartor M, Comin-Colet J, Vila J, Enjuanes C, Bruguera J, Escalada F, Gea J, Orozco-Levi M. High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. Eur J Heart Fail. 2013 Aug;15(8):892-901. doi: 10.1093/eurjhf/hft035. Epub 2013 Mar 19.
PubMed 23512093
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INCA Study: Inspiratory Muscle Training in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01606553
- Acronym / sponsor ID
- INCA / INCA
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, respiratory muscle weakness, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 May 2012 (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 determine whether a high intensity short duration inspiratory muscle training is feasible, secure and effective to improve respiratory muscle function (strength and resistance), health-related quality of life, and to assess potential correlations with health resources utilization.
Detailed description
Patients with chronic heart failure (CHF) often refer exercise intolerance, marked fatigue and dyspnea at low exercise intensities. This characteristic feature might be generated by respiratory and skeletal muscle dysfunction, and it´s has been described as a comorbid status, reflecting the systemic impact of heart failure. Despite the availability of effective pharmacologic treatments, patients with CHF continue to experience progressively worsening symptoms, frequent hospital admission and premature death. Reduced physical functioning, role limitation, and lack of energy may interfere with daily activities as the condition worsens and thereby severely reduce the quality of life in CHF patients. The ACCF/AHA Guidelines for the diagnosis and management of heart failure recommend exercise training as an adjunctive approach to improve clinical status in stable adult patients with current or prior symptoms of heart failure and reduced left ventricular ejection fraction. A wide variety of studies have focussed on respiratory muscles abnormalities in CHF patients. Reduced strength and endurance of respiratory muscles are currently recognized as additional factors implicated in the limited exercise response and quality of life, as well as in a poor prognosis. Additionally, inspiratory muscle training (IMT) has shown to result in improvements on inspiratory strength, functional capacity, ventilatory response to exercise, recovery oxygen uptake kinetics, and quality of life of CHF patients with respiratory muscle weakness. The optimal training scheme remains still to be defined. Most of clinical trials have demonstrated the effectiveness of a low-intensity IMT (maximum 38 cmH2O), but there is little information of the training effects when using higher training loads. Our research group has demonstrated that a short-time high-intensity respiratory training in patients with chronic obstructive pulmonary disease afford to reach good functional results in a shorter time, which affords to make more efficient in terms of time the rehabilitation program and to reach to more patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity IMT | Experimental | Device: High-intensity IMTHigh intensity short duration respiratory muscle training (IMT) using a dual-vave prototype |
| Sham High-intensity IMT | Active comparator | Device: Sham High-intensity IMTHigh intensity short duration respiratory muscle training (IMT) using a sham dual-vave prototype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 18 years;
- chronic heart failure (CHF) of any etiology;
- clinically stable condition, with no worsening of heart failure or change in cardiac medication in the previous 3 months and during the study; and
- ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
Key exclusion criteria (3 listed)
- previous history of any chronic respiratory disease;
- not to have performed any kind of general or respiratory training in the previous 3 months.
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 |
|---|---|---|
| High-intensity IMTAlso: Orygen-Dual valve prototypeHigh intensity short duration respiratory muscle training with a valve prototype | Device | High-intensity IMT |
| Sham High-intensity IMTAlso: Sham Orygen-Dual valve prototypeHigh intensity short duration respiratory muscle training using a sham valve prototype | Device | Sham High-intensity IMT |
Primary outcome
Change in respiratory muscle function strength
Time frame: Baseline to 4 weeks
Transducer measuring maximal inspiratory and expiratory pressures
3 secondary outcomes
Change in health-related quality of life
Time frame: Baseline to 4 weeks
Adverse effects from training
Time frame: Baseline to week 4
Health care utilization
Time frame: Baseline to one year
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 17 Feb 2016.
- Derived from this study: PubMed 23512093Marco E, Ramirez-Sarmiento AL, Coloma A, Sartor M, Comin-Colet J, Vila J, Enjuanes C, Bruguera J, Escalada F, Gea J, Orozco-Levi M. High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. Eur J Heart Fail. 2013 Aug;15(8):892-901. doi: 10.1093/eurjhf/hft035. Epub 2013 Mar 19.
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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.
Ferran Escalada, MD, PhD study director
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity IMT in people with Chronic Heart Failure, run by Parc de Salut Mar at 1 site in Spain.
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 4 inclusion and 3 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 17 Feb 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 Spain. 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?
Change in respiratory muscle function strength (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606553, which also lists 1 linked publication.
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 17 Feb 2016.