Yoga and breathing technique training in patients with heart failure and preserved ejection fraction: study protocol for a randomized clinical trial.

Source:   Trials 2018 Jul 28 . 19 ( 1 ) : 405 . doi: 10.1186/s13063-018-2802-5 . 2018 07 28
PMID: 30055633
DOI: 10.1186/s13063-018-2802-5

ABSTRACT

BACKGROUND

Current therapies for heart failure (HF) are followed by strategies to improve quality of life and exercise tolerance, besides reducing 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, maximal oxygen uptake (VO2), functional capacity, respiratory responses to exercise, and quality of life. Yoga therapies have been shown to improve quality of life, inflammatory markers, and peak VO2 mostly in HF patients with a reduced ejection fraction. However, the effect of different yoga breathing techniques in patients showing HF with a preserved ejection fraction (HFpEF) remain to be assessed.

METHODS/DESIGN

A PROBE (prospective randomized open blinded end-point) parallel-group trial will be conducted at two specialized HF clinics. Adult patients previously diagnosed with HFpEF will be included. After signing informed consent and performing a pre-test intervention, patients will be randomized into three groups and provided with either (1) active yoga breathing techniques; (2) passive yoga breathing techniques (pranayama); or and (3) control (standard pharmacological treatment). Follow-up will last 8 weeks (16 sessions). The post-intervention tests will be performed at the end of the intervention period for analysis of outcomes. Interventions will occur continuously according to patients' enrollment. The main outcome is respiratory muscular resistance. A total of 33 enrolled patients are expected. The present protocol followed the SPIRIT guidelines and fulfilled the SPIRIT checklist.

DISCUSSION

This trial is probably the first to assess the effects of a non-pharmacological intervention, namely yoga and specific breathing techniques, to improve cardiorespiratory function, autonomic system, and quality of life in patients with HFpEF.

TRIAL REGISTRATION

REBEC Identifier: RBR-64mbnx (August 19, 2012). Clinical Trials Register: NCT03028168 . Registered on 16 January 2017).

Author information
  1. School of Medicine, Post-Graduate Program in Health Sciences: Cardiology and Cardiovascular Sciences, Federal University of Rio Grande do Sul, Ramiro Barcelos, 2400, 2nd floor - Rio Branco, Porto Alegre, RS, CEP 90035-903, Brazil. lopescarla.p@gmail.com.
  2. Cardiovascular Division, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil. lopescarla.p@gmail.com.
  3. LaFIEx - Laboratory of Pathophysiology of Exercise, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil. lopescarla.p@gmail.com.
  4. School of Physical Education, Lutheran University of Brazil - ULBRA, Canoas, RS, Brazil. lopescarla.p@gmail.com.
  5. School of Medicine, Lutheran University of Brazil - ULBRA, Canoas, RS, Brazil.
  6. Cardiovascular Division, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
  7. School of Medicine, Post-Graduate Program in Health Sciences: Cardiology and Cardiovascular Sciences, Federal University of Rio Grande do Sul, Ramiro Barcelos, 2400, 2nd floor - Rio Branco, Porto Alegre, RS, CEP 90035-903, Brazil.
  8. LaFIEx - Laboratory of Pathophysiology of Exercise, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
  9. School of Physical Education, Lutheran University of Brazil - ULBRA, Canoas, RS, Brazil.
  10. Unit of Biostatistics, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
KEYWORDS:
Autonomic system , Heart failure with preserved ejection fraction , Maximal inspiratory pressure , Maximal oxygen uptake , Randomized controlled trial , Respiratory techniques , Yoga .
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