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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00969345

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Aug 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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.

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

Primary Outcome Measures

Heart Rate Variability [4 months]

Secondary Outcome Measures

baroreflex gain [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Health elderly subjects

Exclusion Criteria:

Use of beta-blockers
Atrial Fibrillation
Previous training in respiratory exercises

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00969345

Other Study ID Numbers:

RESP-HRV

First Posted:

Sep 1, 2009

Last Update Posted:

Sep 1, 2009

Last Verified:

Aug 1, 2009

Keywords provided by , ,

Healthy Elderly Subjects

Respiratory Yoga Exercises

Heart Rate Variability

Baroreflex

Quality of Life

Study Results

No Results Posted as of Sep 1, 2009