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Clinical Trials/CTRI/2012/09/003017
CTRI/2012/09/003017Active, not recruitingNot Applicable

Effect of yoga therapy on cardiac autonomic functions and oxidative stress in prehypertension subjects: a randomized controlled study

Intramural fund JIPMER Pondicherry1 site in 1 country204 target enrollmentStarted: August 30, 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
204
Locations
1
Primary Endpoint
The addition of yoga therapy to standard lifestyle modification approaches confers additional benefits in terms of:

Study Overview

Brief Summary

This is a randomized controlled study, the subjects with prehypertension (systolic BP 120-139 mmHg and/or diastolic BP 80-89 mmHg) will be screened in various OPDs & staffs of JIPMER, government officials and also through various screening camps in Pondicherry. After the baseline recording they will be randomized to either lifestyle modification (LSM) group or LSM + yoga group for 12 weeks. The expected primary outcome will be improved resting blood pressure, cardiovagal modulation and oxidative stress parameters. The secondary outcomes will be improved quality of life, physical and mental well-being and cardiovascular risk for next ten years.

Study Design

Study Type
Interventional
Allocation
Permuted block randomization, variable
Masking
Not Applicable

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)

Inclusion Criteria

  • •SBP : 120 – 139 mmHg and / or DBP : 80 – 89 mmHg Age : 20 – 60 years Gender : both Willing to practice yoga Written informed consent.

Exclusion Criteria

  • •Diabetes mellitus Cardiovascular disease Autonomic failure Renal insufficiency Patients on drug treatment for prehypertension Any physical condition hindering the performance of yoga Subjects already practicing yoga Sports persons, athletes & body builders.

Outcomes

Primary Outcomes

The addition of yoga therapy to standard lifestyle modification approaches confers additional benefits in terms of:

Time Frame: After 12 weeks of intervention

1. Lowering resting blood pressure

Time Frame: After 12 weeks of intervention

2. Increasing overall short-term HRV

Time Frame: After 12 weeks of intervention

3. Indices of oxidative stress

Time Frame: After 12 weeks of intervention

Secondary Outcomes

  • Improvement in,(1. Quality of life)

Investigators

Sponsor
Intramural fund JIPMER Pondicherry
Sponsor Class
Research institution and hospital

Study Sites (1)

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