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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00969345
First received: August 31, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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 Intervention Phase
Elderly Subjects
Respiration Exercises
Other: Stretching Exercises
Other: Respiratory Exercises conducted twice a day for 10 minutes
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Heart Rate Variability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • baroreflex gain [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969345

Locations
Brazil
Heart Institute (InCor)
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Danilo F Santaella Heart Institute (InCor)
Principal Investigator: Geraldo Lorenzi-Filho, MD, PhD Heart Institute
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geraldo Lorenzi-Filho, Heart Institute InCor - University of Sao Paulo Medical School
ClinicalTrials.gov Identifier: NCT00969345     History of Changes
Other Study ID Numbers: RESP-HRV
Study First Received: August 31, 2009
Last Updated: August 31, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Healthy Elderly Subjects
Respiratory Yoga Exercises
Heart Rate Variability
Baroreflex
Quality of Life

ClinicalTrials.gov processed this record on April 16, 2014