Clinical trial NCT05533268: Effect of Mental and Physical Training on Blood Pressure
Official title: Efficacy of Mental and Physical Training on Blood Pressure and Resting Heart Rate Among Physically Inactive Young Adults With Elevated and High Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated Blood Pressure
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Elevated blood pressure or prehypertension is highly associated with increased risk of developing hypertension, cardiovascular event, and type II diabetes. Many physically inactive young adults, particularly in Malaysia have blood pressure higher than normal range, therefore it is important to control the blood pressure within normal range as prophylactic measure. This experimental research will be carried out to study the effect of physical training (aerobic exercise) and mental training (mindfulness meditation) with diet as a control group on the systolic blood pressure, diastolic blood pressure and resting heart rate among young adult with elevated blood pressure living a sedentary lifestyle. Participant will be divided into 2 experimental groups (mental and physical training) and 1 control group (Dietary Approaches to Stop Hypertension -DASH diet plan) who need to complete the prescribed intervention for 6 weeks. Results will be analysed by repeated measures ANOVA followed by post-hic test.


Eligibility criteria: Inclusion Criteria:

* Male adults aged 18-25 years
* Normal BMI (18.5-24.9)
* Physically inactive
* SBP between 120-139 mmHg and/or DBP between 60-89 mmHg
* No hearing abnormalities
* Willing to participate

Exclusion Criteria:

* Participants who have cardiovascular, musculoskeletal, and neurological disorders or any other medical condition that would restrict them to participate in the exercise
* Those who are taking antihypertensive medications or other medications that will affect their BP and heart rate
* Participants who are currently engaging in any form of relaxation techniques such as yoga or meditation
* Individuals who are actively engaged in physical activities

Primary outcomes:
measure: Change from Baseline Systolic Blood Pressure at 6 weeks.
timeFrame: At baseline over a period of 6 weeks.
measure: Change from Baseline Diastolic Blood Pressure at 6 weeks.
timeFrame: At baseline over a period of 6 weeks.
measure: Change from Baseline Mean Arterial Pressure at 6 weeks.
timeFrame: At baseline over a period of 6 weeks.
measure: Change from Baseline Resting Heart Rate at 6 weeks.
timeFrame: At baseline over a period of 6 weeks.
measure: Change from Baseline Pulse Pressure at 6 weeks.
timeFrame: At baseline over a period of 6 weeks.
Secondary outcomes:
measure: Change from Baseline Body Mass Index at 6 weeks.
timeFrame: At baseline over a period of 6 weeks.
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Universiti Tunku Abdul Rahman
state: Selangor
Study officials:
References: