Yôga and Breathing Techniques Training in Patients With Heart Failure and Preserved Ejection Fraction
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|ClinicalTrials.gov Identifier: NCT03028168|
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Failure Heart Failure, Diastolic||Other: Yôga Other: Breathing technique Other: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Yôga and Breathing Techniques Training in Patients With Heart Failure and Preserved Ejection Fraction: Study Protocol for a Randomized Clinical Trial|
|Actual Study Start Date :||August 2012|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||August 2017|
Experimental: Intervention Yôga
Active protocol with yôga body movements performed along with respiratory vigorous, without contentions. Two sessions per week, with 45 minutes duration.
Intervention observing respiratory frequency (RF) of 15- 20 respiratory cycles per minute (rcpm). A standardized 7-minute final relaxation .
Experimental: Intervention breathing technique
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
Other: Breathing technique
Intervention uses diaphragmatic breathing, observing slow respiratory frequency, between 5-8 rcpm. A standardized 7-minute final relaxation.
Experimental: Control group
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.
Other: Control group
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
- Maximal inspiratory pressure (PImax) [ Time Frame: up to 8 weeks ]Inspiratory muscle strength by measuring maximal inspiratory pressure (PImax)
- Peak oxygen uptake (peak VO2) [ Time Frame: Baseline and 8 weeks ]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 [ Time Frame: Baseline and 8 weeks ]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) [ Time Frame: Baseline and 8 weeks ]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 [ Time Frame: Baseline and 8 weeks ]Quality of life Minnesota scores as a specific inventory for patients with Heart Failure.
- N-terminal pro-brain natriuretic (NT-proBNP) [ Time Frame: Baseline and 8 weeks ]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 [ Time Frame: Baseline and 8 weeks ]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.
- Other pulmonary functions - Inspiratory muscle force [ Time Frame: Baseline and 8 weeks ]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.
- Oher pulmonary functions - Inspiratory muscle endurance [ Time Frame: Baseline and 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028168
|Hospital ULBRA - Mãe de Deus|
|Canoas, Rio Grande Do Sul, Brazil, 92425900|
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90035903|
|Principal Investigator:||Andréia Biolo, MD||Hospital de Clinicas de Porto Alegre|