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Effects of Respiratory Yoga Training on Heart Rate Variability and Baroreflex of Healthy Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00969345
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : September 1, 2009
Sponsor:
Information provided by:
University of Sao Paulo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Elderly Subjects Respiration Exercises Other: Stretching Exercises Other: Respiratory Exercises conducted twice a day for 10 minutes Phase 3

Detailed Description:

Heart rate variability was performed using the autoregressive model, and the baroreflex was calculated with the spontaneous approach, both with the softwares developed in Milan by Alberto Porta in a non-invasive way.

The frequency domain analysis of heart rate, respiration and systolic blood pressure were conducted, consisting of calculating the power spectral density with the minimum error predicted by Akaike's algorithm. Spectral power was then subdivided into two bands of physiological interest: low - (LF 0.03-0.15 Hz) indicating predominant sympathetic modulation, and high - (HF 0.15-0.5 Hz) frequency, indicating parasympathetic modulation of the heart. The fraction calculated dividing LF by HF (LF/HF ratio) provided information of sympathovagal balance to the heart. The spectral analysis of Systolic Blood Pressure provided information of the vasomotor tone, and the integration of heart rate information with these data also provided information about the spontaneous baroreflex gain.

Other questionnaires used were: Pittsburgh Quality of Sleep Questionnaire, Stress Symptoms Questionnaire by Marilda Lipp - validated in Brazil, and Beck's anxiety and depression inventories.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Respiratory Yoga Training (Bhastrika) on Heart Rate Variability and Baroreflex, and Quality of Life of Healthy Elderly Subjects
Study Start Date : August 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Control Group
Stretching exercises performed twice a day for 10 minutes (4 months)
 Other: Stretching Exercises
Conducted twice a week, with instructions for home exercises twice a day, and registering each session on a log sheet.
Active Comparator: Respiration Group
Respiratory Yoga exercises performed twice a day for 10 minutes (4 months)
 Other: Respiratory Exercises conducted twice a day for 10 minutes
Conducted twice a week, with instructions for home exercises twice a day, and registering each session on a log sheet.


Outcome Measures
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Primary Outcome Measures :
  1. Heart Rate Variability [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. baroreflex gain [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health elderly subjects

Exclusion Criteria:

  • Use of beta-blockers
  • Atrial Fibrillation
  • Previous training in respiratory exercises
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00969345


Locations
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Brazil
Heart Institute (InCor)
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Danilo F Santaella Heart Institute (InCor)
Principal Investigator: Geraldo Lorenzi-Filho, MD, PhD Heart Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Geraldo Lorenzi-Filho, Heart Institute InCor - University of Sao Paulo Medical School
ClinicalTrials.gov Identifier: NCT00969345    
Other Study ID Numbers: RESP-HRV
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: September 1, 2009
Last Verified: August 2009
Keywords provided by University of Sao Paulo:
Healthy Elderly Subjects
Respiratory Yoga Exercises
Heart Rate Variability
Baroreflex
Quality of Life