Heart FailureNCT00634296
The Effects of the Inspiratory Muscle Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients.
A study testing Inspiratory muscle added by aerobic to aerobic alone in people with Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This study aims to compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness. To do so, strength and endurance of inspiratory muscles, functional capacity, quality of life, heart rate variability and sleep apnea… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Inspiratory muscle added by aerobic to aerobic alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2005to Mar 2010
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- previous history of symptomatic heart failure caused by left ventricular systolic dysfunction
- inspiratory muscle weakness (PImax < 70% of the predicted)
- clinical stability, including no change in medications for the past three months
Who cannot join
- unstable angina
- myocardial infarction, or cardiac surgery within the previous three months
- chronic metabolic, orthopedic, or infectious diseases
- treatments with steroids, hormones, or cancer chemotherapy
- history of exercise-induced asthma, chronic obstructive pulmonary disease
- smokers
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Jorge P. Ribeiro, MD, ScD, +55 51 9982 4984, jpribeiro@cpovo.net
Eliane Winkelmann, MS, +55 55 9922 4402, elianew@unijui.edu.br
About this study
Official title: The Effects of the Inspiratory Muscle Training Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients With Inspiratory Muscle Weakness.
This study aims to compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness. To do so, strength and endurance of inspiratory muscles, functional capacity, quality of life, heart rate variability and sleep apnea evaluations will be conducted in patients with heart failure.
Read the detailed description
A sample comprising at least 30 individuals is necessary. These subjects will be randomized in two groups, one consisting of inspiratory muscle training plus aerobic training, whereas the other will consist of the aerobic training alone.
This prospective, randomized, controlled trial will include patients with the diagnosis of chronic heart failure attributable to left ventricular systolic dysfunction who will be recruited from the Heart Failure Clinic.
Entry criteria for the study are a previous history of symptomatic heart failure caused by left ventricular systolic dysfunction, inspiratory muscle weakness (PImax < 70% of the predicted), and clinical stability, including no change in medications for the past three months.
Exclusion criteria will be unstable angina, myocardial infarction, or cardiac surgery within the previous three months, chronic metabolic, orthopedic, or infectious diseases, treatments with steroids, hormones, or cancer chemotherapy, history of exercise-induced asthma, chronic obstructive pulmonary disease and smokers will be not recruited.
The protocol was approved by the Committee for Ethics in Research of Hospital de Clinics de Porto Alegre and Ijuí University and all subjects are required to sign an informed consent form.
Variables will be measured by strength and endurance (progressive and constant load), 6-min walk test, cardiopulmonary exercise testing, quality of life questionnaire, evaluation of the heart rate variability and sleep apnea.
The inspiratory muscle training plus aerobic training will consist of cycle exercise (3 sessions/week) and inspiratory exercise by using Threshold equipment for 30 min, 7 times per week, whereas aerobic training group will perform only cycle exercise. Both treatments will last 12 weeks.
- Conditions
- Heart Failure
- Being tested
- Inspiratory muscle added by aerobic to aerobic alone
- Keywords
- Heart failure, Systolic dysfunction, Inspiratory muscle weakness
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle added by aerobic to aerobic aloneOther
Also called Aerobic: G1, Inspiratory muscle added by aerobic: G2
Inspiratory muscle added by aerobic to aerobic alone
| Study group | Role | What they receive |
|---|---|---|
| G2 | Active comparator | Inspiratory muscle training added by aerobic training to aerobic training alone Receives: Other: Inspiratory muscle added by aerobic to aerobic alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness.
Measured: one year
Secondary outcomes (1)
To compare effects between the training groups evaluating strength and endurance of inspiratory muscles; functional capacity; the physical and psychological perceptions of quality of life and heart rate variability and sleep apnea.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMar 2005
- Primary completionMar 2008 (estimated)
- Study completionMar 2010 (estimated)
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Jorge P. Ribeiro, MD, ScD, Principal investigator, Associate Professor and Chief of Non-invasive Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634296
- Sponsor's protocol ID
- HCPA2004-302
- Status last verified
- Mar 2008
- First submitted
- 6 Mar 2008
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Winkelmann ER, Chiappa GR, Lima CO, Viecili PR, Stein R, Ribeiro JP. Addition of inspiratory muscle training to aerobic training improves cardiorespiratory responses to exercise in patients with heart failure and inspiratory muscle weakness. Am Heart J. 2009 Nov;158(5):768.e1-7. doi: 10.1016/j.ahj.2009.09.005. Epub 2009 Oct 2.
PubMed 19853695
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Inspiratory Muscle Training Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients With Inspiratory Muscle Weakness.
- ClinicalTrials.gov ID
- NCT00634296
- Acronym / sponsor ID
- HCPA2004-302
- Conditions
- Heart Failure
- Keywords
- Heart failure, Systolic dysfunction, Inspiratory muscle weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 13 Mar 2008 (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 study aims to compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness. To do so, strength and endurance of inspiratory muscles, functional capacity, quality of life, heart rate variability and sleep apnea evaluations will be conducted in patients with heart failure.
Detailed description
A sample comprising at least 30 individuals is necessary. These subjects will be randomized in two groups, one consisting of inspiratory muscle training plus aerobic training, whereas the other will consist of the aerobic training alone.
This prospective, randomized, controlled trial will include patients with the diagnosis of chronic heart failure attributable to left ventricular systolic dysfunction who will be recruited from the Heart Failure Clinic.
Entry criteria for the study are a previous history of symptomatic heart failure caused by left ventricular systolic dysfunction, inspiratory muscle weakness (PImax < 70% of the predicted), and clinical stability, including no change in medications for the past three months.
Exclusion criteria will be unstable angina, myocardial infarction, or cardiac surgery within the previous three months, chronic metabolic, orthopedic, or infectious diseases, treatments with steroids, hormones, or cancer chemotherapy, history of exercise-induced asthma, chronic obstructive pulmonary disease and smokers will be not recruited.
The protocol was approved by the Committee for Ethics in Research of Hospital de Clinics de Porto Alegre and Ijuí University and all subjects are required to sign an informed consent form.
Variables will be measured by strength and endurance (progressive and constant load), 6-min walk test, cardiopulmonary exercise testing, quality of life questionnaire, evaluation of the heart rate variability and sleep apnea.
The inspiratory muscle training plus aerobic training will consist of cycle exercise (3 sessions/week) and inspiratory exercise by using Threshold equipment for 30 min, 7 times per week, whereas aerobic training group will perform only cycle exercise. Both treatments will last 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G2 | Active comparator | Other: Inspiratory muscle added by aerobic to aerobic aloneInspiratory muscle training added by aerobic training to aerobic training alone |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- previous history of symptomatic heart failure caused by left ventricular systolic dysfunction
- inspiratory muscle weakness (PImax < 70% of the predicted)
- clinical stability, including no change in medications for the past three months
Key exclusion criteria (6 listed)
- unstable angina
- myocardial infarction, or cardiac surgery within the previous three months
- chronic metabolic, orthopedic, or infectious diseases
- treatments with steroids, hormones, or cancer chemotherapy
- history of exercise-induced asthma, chronic obstructive pulmonary 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 added by aerobic to aerobic aloneAlso: Aerobic: G1, Inspiratory muscle added by aerobic: G2Inspiratory muscle added by aerobic to aerobic alone | Other | G2 |
Primary outcome
To compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness.
Time frame: one year
1 secondary outcome
To compare effects between the training groups evaluating strength and endurance of inspiratory muscles; functional capacity; the physical and psychological perceptions of quality of life and heart rate variability and sleep apnea.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2008.
- Derived from this study: PubMed 19853695Winkelmann ER, Chiappa GR, Lima CO, Viecili PR, Stein R, Ribeiro JP. Addition of inspiratory muscle training to aerobic training improves cardiorespiratory responses to exercise in patients with heart failure and inspiratory muscle weakness. Am Heart J. 2009 Nov;158(5):768.e1-7. doi: 10.1016/j.ahj.2009.09.005. Epub 2009 Oct 2.
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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.
Jorge P. Ribeiro, MD, ScD principal investigator
Associate Professor and Chief of Non-invasive Cardiology
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 added by aerobic to aerobic alone in people with Heart Failure, run by Hospital de Clinicas de Porto Alegre 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 6 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 13 Mar 2008. 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 Jorge P. Ribeiro, MD, ScD (+55 51 9982 4984, jpribeiro@cpovo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness. (time frame: one year). 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 NCT00634296, 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 13 Mar 2008.