Heart FailureNCT03247361
High-intensity vs. Low-intensity Inspiratory Muscle Training in Patients With Heart Failure
A study testing High-intensity IMT + Aerobic/resistance exercise and Low-intensity IMT + Aerobic/resistance exercise in people with Heart Failure, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
It is well-known that muscle weakness and deconditioning play an important role in low exercise capacity of patients with HF. Interestingly, not only peripheral muscles are impaired, but also respiratory muscles. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- High-intensity IMT + Aerobic/resistance exercise and Low-intensity IMT + Aerobic/resistance exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2017to 1 Aug 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The target population consists of adults patients aged ≥ 18 years with heart failure and New York Heart Association (NYHA) class I-III.
Who cannot join
- Unstable angina;
- coronary revascularization;
- Decompensated heart failure functional class IV (NYHA);
- Recent transplant or hospitalization (6 months <);
- Chronic Obstructive Pulmonary Disease;
- Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases;
- Recent myocardial infarction or cardiac surgery (less than 6 months);
- Atrial Fibrillation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Mansueto Gomes Neto
Salvador, Estado de Bahia, 40100-110
Mansueto G Neto, PhD
About this study
Official title: The Addition of High-intensity vs. Low-intensity Inspiratory Muscle Training to Combined Aerobic and Resistance Exercise in Patients With Heart Failure
It is well-known that muscle weakness and deconditioning play an important role in low exercise capacity of patients with HF. Interestingly, not only peripheral muscles are impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of inspiratory muscles have been associated with low quality of life and poor prognosis, which make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular rehabilitation.The specifications of the loads to be imposed during IMT is the main factor determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory workload during exercise. Thus, purpose of this report was to perform a randomized clinical trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic and resistance Exercise in patients with heart failure.
- Conditions
- Heart Failure
- Being tested
- High-intensity IMT + Aerobic/resistance exercise, Low-intensity IMT + Aerobic/resistance exercise, Sham IMT + Aerobic/resistance exercise
- Keywords
- Heart Failure; Rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity IMT + Aerobic/resistance exerciseOther
High-intensity IMT
Low-intensity IMT + Aerobic/resistance exerciseOther
Low-intensity IMT
Sham IMT + Aerobic/resistance exerciseOther
Aerobic and resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| High-intensity IMT | Experimental | High-intensity IMT + Aerobic/resistance exercise
IMT: Training loads will be adjusted weekly to the maximal inspiratory pressure (MIP). In the first 2 weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 30 sec, with 30-sec of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 10 min and 30 sec. From the third week the protocol will be of 2 min warm-up with intensity 30% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 60 sec, with 60-second of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 17 min.
Exercise: see group Combined aerobic/resistance exercise Receives: Other: High-intensity IMT + Aerobic/resistance exercise |
| Low-intensity IMT | Active comparator | Low-intensity IMT + Aerobic/resistance exercise
IMT:Training loads will be also adjusted weekly to the maximal inspiratory pressure (MIP). In the first two weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will be held with 3 sets of 15 repetitions, with 40% of MIP, finishing the training with 20% of MIP for 2 minutes. From the third week the protocol will be of 2 minutes warm-up with intensity 30% of MIP. The training will be held with 3 sets of 15 repetitions, with 60% of MIP, finishing the training with 30% of MIP for 2 minutes.
Exercise: see group Combined aerobic/resistance exercise Receives: Other: Low-intensity IMT + Aerobic/resistance exercise |
| Aerobic/resistance exercise | Sham comparator | Sham IMT + Aerobic/resistance exercise
Aerobic session will consist of a 4-min of warm-up, 20 minutes of exercise, and 4 min of cool-down. Intensity will set by the formula: Training HR = (maximum HR - resting HR) × intensity % + resting HR. Patients will exercise using 30 seconds, high-intensity work phases 0.7% followed by 1-minute recovery bouts 0.5%. Resistance exercise will consist of dynamic lower and upper limb exercise. Upper limb exercises will include 3 sets of exercises for each muscle group performed with 10 repetitions each. Lower limb exercises will include 3 sets of exercises for each muscle group performed with 12 repetitions each. Resistance exercises will be performed at 12-MR. Receives: Other: Sham IMT + Aerobic/resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Capacity
Six-minute walk test
Measured: 10 weeks
Health-Related Quality of Life: MLHFQ
Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)
Measured: 10 weeks
Secondary outcomes (2)
Respiratory muscle strength
Maximal respiratory pressures
Measured: 10 weeks
Disability
The World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 Aug 2017
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2020 (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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansueto Gomes Neto, Federal University of Bahia
- Investigators
- Mansueto Gomes-Neto, PhD, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247361
- Sponsor's protocol ID
- FUBahia HIIT IMT
- Status last verified
- Nov 2018
- First submitted
- 9 Aug 2017
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of High-intensity vs. Low-intensity Inspiratory Muscle Training to Combined Aerobic and Resistance Exercise in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03247361
- Acronym / sponsor ID
- FUBahia HIIT IMT
- Conditions
- Heart Failure
- Keywords
- Heart Failure; Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 11 Aug 2017 (actual)
- 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.
It is well-known that muscle weakness and deconditioning play an important role in low exercise capacity of patients with HF. Interestingly, not only peripheral muscles are impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of inspiratory muscles have been associated with low quality of life and poor prognosis, which make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular rehabilitation.The specifications of the loads to be imposed during IMT is the main factor determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory workload during exercise. Thus, purpose of this report was to perform a randomized clinical trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic and resistance Exercise in patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity IMT | Experimental | Other: High-intensity IMT + Aerobic/resistance exerciseHigh-intensity IMT + Aerobic/resistance exercise IMT: Training loads will be adjusted weekly to the maximal inspiratory pressure (MIP). In the first 2 weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 30 sec, with 30-sec of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 10 min and 30 sec. From the third week the protocol will be of 2 min warm-up with intensity 30% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 60 sec, with 60-second of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 17 min. Exercise: see group Combined aerobic/resistance exercise |
| Low-intensity IMT | Active comparator | Other: Low-intensity IMT + Aerobic/resistance exerciseLow-intensity IMT + Aerobic/resistance exercise IMT:Training loads will be also adjusted weekly to the maximal inspiratory pressure (MIP). In the first two weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will be held with 3 sets of 15 repetitions, with 40% of MIP, finishing the training with 20% of MIP for 2 minutes. From the third week the protocol will be of 2 minutes warm-up with intensity 30% of MIP. The training will be held with 3 sets of 15 repetitions, with 60% of MIP, finishing the training with 30% of MIP for 2 minutes. Exercise: see group Combined aerobic/resistance exercise |
| Aerobic/resistance exercise | Sham comparator | Other: Sham IMT + Aerobic/resistance exerciseSham IMT + Aerobic/resistance exercise Aerobic session will consist of a 4-min of warm-up, 20 minutes of exercise, and 4 min of cool-down. Intensity will set by the formula: Training HR = (maximum HR - resting HR) × intensity % + resting HR. Patients will exercise using 30 seconds, high-intensity work phases 0.7% followed by 1-minute recovery bouts 0.5%. Resistance exercise will consist of dynamic lower and upper limb exercise. Upper limb exercises will include 3 sets of exercises for each muscle group performed with 10 repetitions each. Lower limb exercises will include 3 sets of exercises for each muscle group performed with 12 repetitions each. Resistance exercises will be performed at 12-MR. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The target population consists of adults patients aged ≥ 18 years with heart failure and New York Heart Association (NYHA) class I-III.
Key exclusion criteria (8 listed)
- Unstable angina;
- coronary revascularization;
- Decompensated heart failure functional class IV (NYHA);
- Recent transplant or hospitalization (6 months <);
- 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 |
|---|---|---|
| High-intensity IMT + Aerobic/resistance exerciseHigh-intensity IMT | Other | High-intensity IMT |
| Low-intensity IMT + Aerobic/resistance exerciseLow-intensity IMT | Other | Low-intensity IMT |
| Sham IMT + Aerobic/resistance exerciseAerobic and resistance exercise | Other | Aerobic/resistance exercise |
Primary outcome
Aerobic Capacity
Time frame: 10 weeks
Six-minute walk test
Health-Related Quality of Life: MLHFQ
Time frame: 10 weeks
Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)
2 secondary outcomes
Respiratory muscle strength
Time frame: 10 weeks
Disability
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
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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.
Mansueto Gomes-Neto, PhD principal investigator
Federal University of Bahia
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 + Aerobic/resistance exercise and Low-intensity IMT + Aerobic/resistance exercise in people with Heart Failure, run by Federal University of Bahia 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 1 inclusion and 8 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 7 Nov 2018. 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 Mansueto Gomes-Neto, PhD (55-71-999188277, mansueto.neto@ufba.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Capacity (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 7 Nov 2018.