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

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          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 (VO 2), functional capacity, respiratory responses to exercise, and quality of life. Yoga therapies have been shown to improve quality of life, inflammatory markers, and peak VO 2 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).

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2802-5) contains supplementary material, which is available to authorized users.

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          Most cited references30

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          The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure.

          Cycle and treadmill exercise tests are unsuitable for elderly, frail and severely limited patients with heart failure and may not reflect capacity to undertake day-to-day activities. Walking tests have proved useful as measures of outcome for patients with chronic lung disease. To investigate the potential value of the 6-minute walk as an objective measure of exercise capacity in patients with chronic heart failure, the test was administered six times over 12 weeks to 18 patients with chronic heart failure and 25 with chronic lung disease. The subjects also underwent cycle ergometer testing, and their functional status was evaluated by means of conventional measures. The walking test proved highly acceptable to the patients, and stable, reproducible results were achieved after the first two walks. The results correlated with the conventional measures of functional status and exercise capacity. The authors conclude that the 6-minute walk is a useful measure of functional exercise capacity and a suitable measure of outcome for clinical trials in patients with chronic heart failure.
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            Reference values for lung function tests: II. Maximal respiratory pressures and voluntary ventilation

            The strength of the respiratory muscles can be evaluated from static measurements (maximal inspiratory and expiratory pressures, MIP and MEP) or inferred from dynamic maneuvers (maximal voluntary ventilation, MVV). Although these data could be suitable for a number of clinical and research applications, no previous studies have provided reference values for such tests using a healthy, randomly selected sample of the adult Brazilian population. With this main purpose, we prospectively evaluated 100 non-smoking subjects (50 males and 50 females), 20 to 80 years old, selected from more than 8,000 individuals. Gender-specific linear prediction equations for MIP, MEP and MVV were developed by multiple regression analysis: age and, secondarily, anthropometric measurements explained up to 56% of the variability of the dependent variables. The most cited previous studies using either Caucasian or non-Caucasian samples systematically underestimated the observed values of MIP (P<0.05). Interestingly, the self-reported level of regular physical activity and maximum aerobic power correlates strongly with both respiratory and peripheral muscular strength (knee extensor peak torque) (P<0.01). Our results, therefore, provide a new frame of reference to evaluate the normalcy of some useful indexes of respiratory muscle strength in Brazilian males and females aged 20 to 80.
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              A comparison of the visual analogue scale and modified Borg scale for the measurement of dyspnoea during exercise.

              1. The intensity of breathlessness during exercise was measured in ten normal subjects using a visual analogue scale (VAS) and a Borg scale to compare the use of the scales and their repeatability, both within the duration of a period of exercise and between tests. For each scale, subjects performed two exercise tests separated by a period of 2-6 weeks. Each exercise test consisted of two cycles of progressively increasing and decreasing workload. 2. All subjects felt confidently able to use both scales to quantify their feelings of breathlessness exclusively of other sensation. Equal preference was expressed for use of a particular scale. 3. With both scales there was a large intersubject variation in the relationship between dyspnoea score and minute ventilation (VE) (P less than 0.01), and in the range of the scale used. 4. There was a good correlation between the VAS and Borg scores at each level of VE (r2 = 0.71), but the VAS score was used over a wider range than the Borg score. 5. The relationship between VE and the dyspnoea score measured by the two techniques was predominantly linear. The mean r2 for VAS score/VE was 0.68 (SD 0.19) and for Borg score/VE the mean r2 was 0.75 (SD 0.13). 6. The relationships VAS score/VE and Borg score/VE were unaffected by the direction in which the workload was varied (P greater than 0.05). 7. VE, measured at each work rate, did not differ between the two cycles (P greater than 0.05) or between the 2 days (P greater than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
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                Author and article information

                Contributors
                lopescarla.p@gmail.com
                luizdanzmann@gmail.com
                moraesr@terra.com.br
                pjcv28@yahoo.com.br
                francisco.meurer@gmail.com
                soaresdouglas.ef@gmail.com
                gaspar.chiappa@gmail.com
                guima98@gmail.com
                tobar4@gmail.com
                biolo.andreia@gmail.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                28 July 2018
                28 July 2018
                2018
                : 19
                : 405
                Affiliations
                [1 ]ISNI 0000 0001 2200 7498, GRID grid.8532.c, 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
                [2 ]ISNI 0000 0001 0125 3761, GRID grid.414449.8, Cardiovascular Division, Hospital de Clínicas de Porto Alegre, ; Porto Alegre, RS Brazil
                [3 ]ISNI 0000 0001 0125 3761, GRID grid.414449.8, LaFIEx - Laboratory of Pathophysiology of Exercise, Hospital de Clínicas de Porto Alegre, ; Porto Alegre, RS Brazil
                [4 ]ISNI 0000 0001 2111 8057, GRID grid.411513.3, School of Physical Education, Lutheran University of Brazil – ULBRA, ; Canoas, RS Brazil
                [5 ]ISNI 0000 0001 2111 8057, GRID grid.411513.3, School of Medicine, Lutheran University of Brazil – ULBRA, ; Canoas, RS Brazil
                [6 ]ISNI 0000 0001 0125 3761, GRID grid.414449.8, Unit of Biostatistics, Hospital de Clínicas de Porto Alegre, ; Porto Alegre, Brazil
                Author information
                http://orcid.org/0000-0002-3383-9019
                Article
                2802
                10.1186/s13063-018-2802-5
                6064087
                30055633
                6f72c302-aa2e-4e18-87a9-ac3e98236203
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 9 March 2017
                : 9 July 2018
                Funding
                Funded by: Fundo de Incentivo à Pesquisa e Educação (FIPE/HCPA)
                Award ID: 11-0069
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                yoga,respiratory techniques,heart failure with preserved ejection fraction,randomized controlled trial,autonomic system,maximal inspiratory pressure,maximal oxygen uptake

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