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

Primary Purpose

Cardiovascular Diseases, Heart Failure, Heart Failure, Diastolic

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Yôga
Breathing technique
Control group
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Diseases focused on measuring Yôga, Breathing Techniques, Heart Failure and Preserved Ejection Fraction

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital ULBRA - Mãe de Deus
  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Intervention Yôga

Intervention breathing technique

Control group

Arm Description

Active protocol with yôga body movements performed along with respiratory vigorous, without contentions. Two sessions per week, with 45 minutes duration.

Passive 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

Control 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.

Outcomes

Primary Outcome Measures

Maximal inspiratory pressure (PImax)
Inspiratory muscle strength by measuring maximal inspiratory pressure (PImax)

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2017
Last Updated
February 22, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03028168
Brief Title
Yôga and Breathing Techniques Training in Patients With Heart Failure and Preserved Ejection Fraction
Official Title
Yôga and Breathing Techniques Training in Patients With Heart Failure and Preserved Ejection Fraction: Study Protocol for a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Failure, Heart Failure, Diastolic
Keywords
Yôga, Breathing Techniques, Heart Failure and Preserved Ejection Fraction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Yôga
Arm Type
Experimental
Arm Description
Active protocol with yôga body movements performed along with respiratory vigorous, without contentions. Two sessions per week, with 45 minutes duration.
Arm Title
Intervention breathing technique
Arm Type
Experimental
Arm Description
Passive 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
Arm Title
Control group
Arm Type
Experimental
Arm Description
Control 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.
Intervention Type
Other
Intervention Name(s)
Yôga
Intervention Description
Intervention observing respiratory frequency (RF) of 15- 20 respiratory cycles per minute (rcpm). A standardized 7-minute final relaxation .
Intervention Type
Other
Intervention Name(s)
Breathing technique
Intervention Description
Intervention uses diaphragmatic breathing, observing slow respiratory frequency, between 5-8 rcpm. A standardized 7-minute final relaxation.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximal inspiratory pressure (PImax)
Description
Inspiratory muscle strength by measuring maximal inspiratory pressure (PImax)
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Peak oxygen uptake (peak VO2)
Description
Peak VO2 will be considered the highest value of VO2 calculated in a 20-second-period during cardiopulmonary exercise testing (CPET)
Time Frame
Baseline and 8 weeks
Title
Vagal activity: heart rate variability- HRV
Description
Twenty-four-hour ECG recordings will be obtained with a light digital recorder for to available of heart rate variability (HRV).
Time Frame
Baseline and 8 weeks
Title
Functional capacity through the 6-minute walk test (6MWD)
Description
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.
Time Frame
Baseline and 8 weeks
Title
Quality of life Minnesota scores
Description
Quality of life Minnesota scores as a specific inventory for patients with Heart Failure.
Time Frame
Baseline and 8 weeks
Title
N-terminal pro-brain natriuretic (NT-proBNP)
Description
NT-proBNP test: N-terminal precursor of natriuretic peptide type B (Brain), clinical specimen by serum, sandwich-type electrochemiluminescence analysis method (COBAS E601-ROCHE).
Time Frame
Baseline and 8 weeks
Title
Echocardiographic - Ejection Fraction
Description
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.
Time Frame
Baseline and 8 weeks
Other Pre-specified Outcome Measures:
Title
Other pulmonary functions - Inspiratory muscle force
Description
Additionally, for the determination of inspiratory muscle force, an incremental test will be used in which patients will breathe continuously through a mouthpiece connected to a measure device. The patients will use an initial load of 50% of PImax, and increments of 10% of PImax will be added every 3 min until the patient is unable to continue breathing.
Time Frame
Baseline and 8 weeks
Title
Oher pulmonary functions - Inspiratory muscle endurance
Description
Additionally, for the determination of inspiratory muscle endurance, an incremental test will be used in which patients will breathe continuously through a mouthpiece connected to a measure device. The protocol, subjects will breathe against a constant inspiratory submaximal load equivalent to 80% of the greatest inspiratory pressure and the time elapsed to task failure will be defined as the inspiratory endurance time.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andréia Biolo, MD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital ULBRA - Mãe de Deus
City
Canoas
State/Province
Rio Grande Do Sul
ZIP/Postal Code
92425900
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30055633
Citation
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.
Results Reference
derived

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

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