NCT00969345

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

Enrollment Period

11 months

First QC Date

August 31, 2009

Last Update Submit

August 31, 2009

Conditions

Keywords

Healthy Elderly SubjectsRespiratory Yoga ExercisesHeart Rate VariabilityBaroreflexQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability

    4 months

Secondary Outcomes (1)

  • baroreflex gain

    4 months

Study Arms (2)

Control Group

SHAM COMPARATOR

Stretching exercises performed twice a day for 10 minutes (4 months)

Other: Stretching Exercises

Respiration Group

ACTIVE COMPARATOR

Respiratory Yoga exercises performed twice a day for 10 minutes (4 months)

Other: Respiratory Exercises conducted twice a day for 10 minutes

Interventions

Conducted twice a week, with instructions for home exercises twice a day, and registering each session on a log sheet.

Control Group

Conducted twice a week, with instructions for home exercises twice a day, and registering each session on a log sheet.

Respiration Group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Danilo F Santaella

    Heart Institute (InCor)

    PRINCIPAL INVESTIGATOR
  • Geraldo Lorenzi-Filho, MD, PhD

    Heart Institute

    PRINCIPAL INVESTIGATOR

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

Locations