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Effects of Yoga Training on Cardiovascular Reactivity to Psychological Stress in Patients With Hypertension

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Yoga training program
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 20-65 years of age
  • 18.5 <=BMI<=29.9
  • have hypertension (clinical diagnosis)
  • resting systolic blood pressure 120-160 mmHg, resting diastolic blood pressure lower than 110 mmHg

Exclusion Criteria:

  • regular exercise behaviors or current participation in yoga programs
  • have cardiovascular diseases, pulmonary diseases, diabetes
  • have musculoskeletal problems that may affect yoga pose practice (e.g., herniated intervertebral disc, spondylolithesis, ankylosing spondylitis)
  • current pregnancy or breastfeeding
  • change of hypertension medication use within 4 weeks

Sites / Locations

  • Kaohsiung Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga

Control

Arm Description

The yoga group will engage in the yoga training program which is 60 minutes per session, 2 times per week for 12 weeks.

The control group will be asked not to participate in any exercise program during the course of the study.

Outcomes

Primary Outcome Measures

Change in blood pressure during rest from baseline to week 13
Blood pressure will be assessed with an OMRON blood pressure monitor.

Secondary Outcome Measures

Change in blood pressure during psychological stress from baseline to week 13
Blood pressure will be assessed with an OMRON blood pressure monitor.

Full Information

First Posted
September 1, 2017
Last Updated
August 19, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03274193
Brief Title
Effects of Yoga Training on Cardiovascular Reactivity to Psychological Stress in Patients With Hypertension
Official Title
Effects of Yoga Training on Cardiovascular Reactivity to Psychological Stress in Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the effects of 12-week yoga training on blood pressure, heart rate, heart rate variability, arterial stiffness, and total peripheral resistance during rest and psychological stress in patients with hypertension. All eligible participants will be randomly assigned to either yoga (n=40) or usual care control (n=40) group. During the 1st lab visit, the experimenter will explain the purpose and procedures of the study. If the participants understand and agree to participate in this study, they will be asked to sign the informed consent. Next, participants will fill out questionnaires, including demographic information, Physical Activity Readiness Questionnaire, perceived stress scale, anxiety inventory, exercise behavior questionnaire, and quality of life scale. Participant's resting blood pressure will be measured. Participants will then be instructed to relax in a supine position for 15 minutes while ECG is recording. Next, participants will perform 5 minutes of stroop task and 5 minutes of mental arithmetic task (mental stressors). ECG and cardiac output will be monitored throughout the whole session. After the stress period, participants will be asked to relax until heart rate becomes stable and return to baseline. The participants will perform the sit-and-reach test. After completing all the baseline testing, the yoga group will begin the training program which is 60 minutes per session, 2 times per week for 12 weeks. The control group will be asked not to participate in any exercise program during the course of the study. Participants will be filling out the same questionnaires and receive measures of blood pressure, ECG, and cardiac output at week 6 and week 12. Additionally, participants will perform the stress tasks and the sit-and-reach test again at week 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
The yoga group will engage in the yoga training program which is 60 minutes per session, 2 times per week for 12 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will be asked not to participate in any exercise program during the course of the study.
Intervention Type
Behavioral
Intervention Name(s)
Yoga training program
Intervention Description
The hatha yoga program will be led by an experienced yoga instructor. Each 60 minutes session will consist of 10 minutes of breathing exercises (pranayama), 40 minutes of yoga pose practice (asana), and 10 minutes of supine meditation/relaxation (savasana). Yoga props, such as blocks and belts, will be used in accordance to each participant's particular body type and needs to help he/she achieve precise yoga postures safely and comfortably. The yoga poses are chosen for providing a restorative session and based on their purported relationship to restorative effects. Participants will be instructed to maintain their concentration and breath control at all times during the yoga session.
Primary Outcome Measure Information:
Title
Change in blood pressure during rest from baseline to week 13
Description
Blood pressure will be assessed with an OMRON blood pressure monitor.
Time Frame
Blood pressure during rest will be measured at baseline and week 13.
Secondary Outcome Measure Information:
Title
Change in blood pressure during psychological stress from baseline to week 13
Description
Blood pressure will be assessed with an OMRON blood pressure monitor.
Time Frame
Blood pressure during psychological stress will be measured at baseline and week 13.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20-65 years of age 18.5 <=BMI<=29.9 have hypertension (clinical diagnosis) resting systolic blood pressure 120-160 mmHg, resting diastolic blood pressure lower than 110 mmHg Exclusion Criteria: regular exercise behaviors or current participation in yoga programs have cardiovascular diseases, pulmonary diseases, diabetes have musculoskeletal problems that may affect yoga pose practice (e.g., herniated intervertebral disc, spondylolithesis, ankylosing spondylitis) current pregnancy or breastfeeding change of hypertension medication use within 4 weeks
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung City
ZIP/Postal Code
80708
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Yoga Training on Cardiovascular Reactivity to Psychological Stress in Patients With Hypertension

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