Clinical trial NCT03274193: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in blood pressure during rest from baseline to week 13
timeFrame: Blood pressure during rest will be measured at baseline and week 13.
Secondary outcomes:
measure: Change in blood pressure during psychological stress from baseline to week 13
timeFrame: Blood pressure during psychological stress will be measured at baseline and week 13.
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
References: