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

NCT03028168 | Completed

• 1 other identifier: 110069
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic

Keywords

Yôga; Breathing Techniques; Heart Failure and Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Maximal inspiratory pressure (PImax)

  Inspiratory muscle strength by measuring maximal inspiratory pressure (PImax)

  up to 8 weeks

Secondary Outcomes (6)

• Peak oxygen uptake (peak VO2)

  Baseline and 8 weeks

• Vagal activity: heart rate variability- HRV

  Baseline and 8 weeks

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

  Baseline and 8 weeks

• Quality of life Minnesota scores

  Baseline and 8 weeks

• N-terminal pro-brain natriuretic (NT-proBNP)

  Baseline and 8 weeks

Other Outcomes (2)

• Other pulmonary functions - Inspiratory muscle force

  Baseline and 8 weeks

• Oher pulmonary functions - Inspiratory muscle endurance

  Baseline and 8 weeks

Study Arms (3)

Intervention Yôga

EXPERIMENTAL

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

Other: Yôga

Intervention breathing technique

EXPERIMENTAL

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

Control group

EXPERIMENTAL

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

Interventions

Yôga OTHER

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

Intervention Yôga

Breathing technique OTHER

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

Intervention breathing technique

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (2)

Hospital ULBRA - Mãe de Deus

Canoas, Rio Grande do Sul, 92425900, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (2)

• 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.

  PMID: 40950502 DERIVED

• 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.

  PMID: 30055633 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Andréia Biolo, MD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 23, 2017
• Study Start: August 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

BR (2)