Effects of Respiratory Yoga Training on Heart Rate Variability and Baroreflex of Healthy Elderly Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
The decreases of physiological capacities which take place with senescence include diminishing respiratory capacity as well as a reduction of heart rate variability and baroreflex sensibility. Altogether, these alterations increase elderly people's frailty and have a negative impact over quality of life. Since Yoga (Indian auto-discipline) has a wide range of respiratory exercises already investigated as components for non-pharmacological treatments for hypertension (situation in which heart rate variability is also diminished), the investigators hypothesis is that the training of respiratory exercises of Yoga may have a significant positive effect on heart rate variability and baroreflex of health elderly subjects, increasing quality of life and reducing frailty. We included 30 health elderly subjects (both sexes, from 60 years-old onwards) divided into 2 randomized experimental groups: control (C) and respiration (R). Each group underwent an entry evaluation, followed by a 4-months training period, after which they were re-evaluated. Control consisted of 2 stretching classes per week, and respiration consisted of 2 respiratory exercises classes a week. Both groups were instructed to perform the exercises at home twice a day, and to keep a record of each session in a log sheet. Evaluations were: WHOQOL-OLD questionnaire for quality of life, 20 minutes of seated rest with heart rate, respiration and blood pressure acquired continuously for further spectral analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2007
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 31, 2009
CompletedFirst Posted
Study publicly available on registry
September 1, 2009
CompletedSeptember 1, 2009
August 1, 2009
11 months
August 31, 2009
August 31, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart Rate Variability
4 months
Secondary Outcomes (1)
baroreflex gain
4 months
Study Arms (2)
Control Group
SHAM COMPARATORStretching exercises performed twice a day for 10 minutes (4 months)
Respiration Group
ACTIVE COMPARATORRespiratory Yoga exercises performed twice a day for 10 minutes (4 months)
Interventions
Conducted twice a week, with instructions for home exercises twice a day, and registering each session on a log sheet.
Conducted twice a week, with instructions for home exercises twice a day, and registering each session on a log sheet.
Eligibility Criteria
You may qualify if:
- Health elderly subjects
You may not qualify if:
- Use of beta-blockers
- Atrial Fibrillation
- Previous training in respiratory exercises
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Institute (InCor)
São Paulo, São Paulo, Brazil
Related Publications (1)
Santaella DF, Devesa CR, Rojo MR, Amato MB, Drager LF, Casali KR, Montano N, Lorenzi-Filho G. Yoga respiratory training improves respiratory function and cardiac sympathovagal balance in elderly subjects: a randomised controlled trial. BMJ Open. 2011 May 24;1(1):e000085. doi: 10.1136/bmjopen-2011-000085.
PMID: 22021757DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danilo F Santaella
Heart Institute (InCor)
- PRINCIPAL INVESTIGATOR
Geraldo Lorenzi-Filho, MD, PhD
Heart Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2009
First Posted
September 1, 2009
Study Start
August 1, 2007
Primary Completion
July 1, 2008
Study Completion
December 1, 2008
Last Updated
September 1, 2009
Record last verified: 2009-08