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Cardiovascular DiseasesNCT03028168

Yôga and Breathing Techniques Training in Patients With Heart Failure and Preserved Ejection Fraction

A study testing Yôga and Breathing technique in people with Cardiovascular Diseases and Heart Failure, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Current therapies for heart failure (HF) bring together strategies to improve quality of life and exercise tolerance, as well as to reduce morbidity and mortality. Some HF patients present changes in the musculoskeletal system and inspiratory muscle weakness, which may be restored by inspiratory muscle training, thus… Read more about this study

Who is it for?
Ages 45 to 75 years
What is being tested?
Yôga and Breathing technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesBrazil
Study dates
Aug 2012to Aug 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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients with a diagnosis of HFpEF, functional capacity class II and III, who are being treated at a specialized HF clinic will be eligible. HF diagnosis will be established by clinical history (signs and symptoms), echocardiographic findings (left ventricular ejection fraction ≥ 50%) and medical records confirming management for HF.

Who cannot join

  • Pulmonary disease (forced vital capacity<80% of predicted and/or forced expiratory volume in 1 s <70% of predicted, significant mitral or aortic valve diseases, history of exercise-induced asthma, and active smoking or alcoholic.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Hospital ULBRA - Mãe de Deus

    Canoas, Rio Grande do Sul, 92425900

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035903

Other trials in Brazil

About this study

Official title: Yôga and Breathing Techniques Training in Patients With Heart Failure and Preserved Ejection Fraction: Study Protocol for a Randomized Clinical Trial

Current therapies for heart failure (HF) bring together strategies to improve quality of life and exercise tolerance, as well as to reduce morbidity and mortality. Some HF patients present changes in the musculoskeletal system and inspiratory muscle weakness, which may be restored by inspiratory muscle training, thus increasing respiratory muscle strength and endurance, maximum oxygen consumption (VO2), functional capacity, respiratory responses to exercise, and quality of life. Yoga therapies have been shown to improve quality of life, inflammatory markers, and VO2 peak in HF patients, mostly with reduced ejection fraction (HFrEF). However, the effect of different yoga breathing techniques in patients with HF with preserved ejection fraction (HFpEF) has yet to be assessed.

Read the detailed description

Yôga techniques without breathing control have shown to improve oxygen consumption in patients with HF, mostly HFrEF. However, almost half of HF patients present with HFpEF, and less studies have been performed in those patients. It has been recently demonstrated that HFpEF induces significant molecular, mitochondrial, histological, and functional alterations in the diaphragm and soleus, which were attenuated by exercise training . In cardiac disease and aging, several authors have shown a significant reduction in heart rate variability (HRV) in the frequency ranges associated with breathing, by using spectral analysis of heart rate (HR) and respiration.Therefore, the present randomized clinical trial (RCT) will be conducted in order to test the hypothesis that an program of yôga and specific breathing techniques with different ventilatory rhythms could be associated with improvement in inspiratory muscle responses, functional capacity, oxygen uptake efficiency slope (OUES), circulatory power, oscillatory ventilation, kinetics of oxygen consumption in the recovery period, distinct features of the autonomic nervous system, natriuretic peptides, echocardiographic measurements, and quality of life (QoL) in patients with HFpEF, with and without inspiratory muscle weakness (IMW).Therefore, the present randomized clinical trial (RCT) will be conducted in order to test the hypothesis that an 8-week program of yôga and specific breathing techniques with different ventilatory rhythms could be associated with improvement in inspiratory muscle responses, functional capacity, oxygen uptake efficiency slope (OUES), circulatory power, oscillatory ventilation, kinetics of oxygen consumption in the recovery period, distinct features of the autonomic nervous system, natriuretic peptides, echocardiographic measurements, and quality of life in patients with HFpEF, with and without IMW.

Being tested
Yôga, Breathing technique, Control group
Keywords
Yôga, Breathing Techniques, Heart Failure and Preserved Ejection Fraction
Medical subject headings
Cardiovascular Diseases, Heart Failure, Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YôgaOther

    Intervention observing respiratory frequency (RF) of 15- 20 respiratory cycles per minute (rcpm). A standardized 7-minute final relaxation .

  • Breathing techniqueOther

    Intervention uses diaphragmatic breathing, observing slow respiratory frequency, between 5-8 rcpm. A standardized 7-minute final relaxation.

  • Control groupOther

    Patients will be oriented to keep their pharmacological routine and daily activities, with no structured exercises. They will have to return to the hospital for post-testing after 8 weeks from randomization

Study groups in NCT03028168
Study groupRoleWhat they receive
Intervention YôgaExperimentalActive protocol with yôga body movements performed along with respiratory vigorous, without contentions. Two sessions per week, with 45 minutes duration.
Receives: Other: Yôga
Intervention breathing techniqueExperimentalPassive protocol, seated patient, no significant body movements. Breathing technique, with alternate nostril breathing combined to inspiratory and expiratory retentions.Two sessions per week, with 45 minutes duration
Receives: Other: Breathing technique
Control groupExperimentalControl group (standard pharmacological treatment). Patients will be oriented to keep their pharmacological routine and daily activities, with no structured exercises. They will have to return to the hospital for post-testing after 8 weeks from randomization.
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal inspiratory pressure (PImax)

    Inspiratory muscle strength by measuring maximal inspiratory pressure (PImax)

    Measured: up to 8 weeks

Secondary outcomes (6)

  1. Peak oxygen uptake (peak VO2)

    Peak VO2 will be considered the highest value of VO2 calculated in a 20-second-period during cardiopulmonary exercise testing (CPET)

    Measured: Baseline and 8 weeks

  2. Vagal activity: heart rate variability- HRV

    Twenty-four-hour ECG recordings will be obtained with a light digital recorder for to available of heart rate variability (HRV).

    Measured: Baseline and 8 weeks

  3. Functional capacity through the 6-minute walk test (6MWD)

    The maximum distance walked in 6 minutes of walking (6MWD).The distance traveled in the time of 6 minutes will be considered according to the predicted for gender and age of the patient.

    Measured: Baseline and 8 weeks

  4. Quality of life Minnesota scores

    Quality of life Minnesota scores as a specific inventory for patients with Heart Failure.

    Measured: Baseline and 8 weeks

  5. N-terminal pro-brain natriuretic (NT-proBNP)

    NT-proBNP test: N-terminal precursor of natriuretic peptide type B (Brain), clinical specimen by serum, sandwich-type electrochemiluminescence analysis method (COBAS E601-ROCHE).

    Measured: Baseline and 8 weeks

  6. Echocardiographic - Ejection Fraction

    Teichholz method: ejection fraction - study Inclusion criteria: EF≥ 50% . Establish a diagnostic measure of HF by confirming preserved ejection fraction and compare this measure at the end of the study.

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2017 (estimated)
  2. Study startAug 2012
  3. Primary completionMay 2017
  4. Study completionAug 2017

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03028168
Sponsor's protocol ID
110069
Status last verified
Feb 2018
First submitted
16 Jan 2017
Last updated
23 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Lopes CP, Danzmann LC, Umpierre D, Moraes RS, Soares DS, Leitao SAT, Filho ASC, Depaoli F, Guimaraes LP, Chiappa G, Vieira PJC, Ribeiro JP, Biolo A. YOGA AND BREATHING TRAINING IN PATIENTS WITH HEART FAILURE AND PRESERVED EJECTION FRACTION: A RANDOMIZED CLINICAL TRIAL. medRxiv [Preprint]. 2025 Sep 5:2025.09.03.25335058. doi: 10.1101/2025.09.03.25335058.

    PubMed 40950502

  • Lopes CP, Danzmann LC, Moraes RS, Vieira PJC, Meurer FF, Soares DS, Chiappa G, Guimaraes LSP, Leitao SAT, Ribeiro JP, Biolo A. Yoga and breathing technique training in patients with heart failure and preserved ejection fraction: study protocol for a randomized clinical trial. Trials. 2018 Jul 28;19(1):405. doi: 10.1186/s13063-018-2802-5.

    PubMed 30055633

Questions about this trial

What is this clinical trial studying?

A study testing Yôga and Breathing technique in people with Cardiovascular Diseases and Heart Failure, run by Hospital de Clinicas de Porto Alegre at 2 sites 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 1 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Maximal inspiratory pressure (PImax) (time frame: up to 8 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 NCT03028168, which also lists 2 linked publications.

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 23 Feb 2018.

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