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CompletedNCT03274193Updated Aug 22, 2022

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

An interventional study of Yoga training program in Hypertension, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension
03

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Yoga

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

    Behavioral: Yoga training program

  • No intervention
    Control

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

Interventions

  • BehavioralYoga training program

    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.

05

What researchers measure

Primary outcomes

  1. Change in blood pressure during rest from baseline to week 13

    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 outcomes

  1. Change in blood pressure during psychological stress from baseline to week 13

    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.

06

Study locations

1 site
  • Kaohsiung Medical University
    Kaohsiung City, 80708, Taiwan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03274193
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Sep 6, 2017
Start date
Mar 1, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Aug 22, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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