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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05533268
Other study ID # MAP vs DASH Diet
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2022
Est. completion date January 19, 2023

Study information

Verified date January 2023
Source Universiti Tunku Abdul Rahman
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date January 19, 2023
Est. primary completion date January 18, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mental training
Mental training (guided mindfulness meditation by Jon Kabat-Zinn for 20 minutes, 3 times per week.
Physical training
Physical training (continuous moderate-intensity training at 40-60% of participants' heart rate reserve for 20 minutes excluding warm-up/cool-down, 3 times per week.
Mental & physical training
Mental and physical training (combination of mindfulness mediation for 20-minutes, 3 times per week and continuous moderate-intensity training for 20 minutes, 3 times per week.
DASH diet
DASH diet ( (more vegetables, fruits and low-fat dairy foods and moderate amounts of whole grains, fish, poultry and nuts; and less than 3 grams of sodium daily) for 6-weeks.

Locations

Country Name City State
Malaysia Universiti Tunku Abdul Rahman Kajang Selangor

Sponsors (1)

Lead Sponsor Collaborator
Universiti Tunku Abdul Rahman

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Systolic Blood Pressure at 6 weeks. Systolic blood pressure (SPB) will be measured at baseline (before intervention begin), after 3 weeks of intervention, and post 6-weeks of intervention. At baseline over a period of 6 weeks.
Primary Change from Baseline Diastolic Blood Pressure at 6 weeks. Diastolic blood pressure (DPB) will be measured at baseline (before intervention begin), after 3 weeks of intervention, and post 6-weeks of intervention. At baseline over a period of 6 weeks.
Primary Change from Baseline Mean Arterial Pressure at 6 weeks. Mean arterial pressure (MAP) will be measured at baseline (before intervention begin), after 3 weeks of intervention, and post 6-weeks of intervention. At baseline over a period of 6 weeks.
Primary Change from Baseline Resting Heart Rate at 6 weeks. Resting heart rate (RHR) will be measured at baseline (before intervention begin), after 3 weeks of intervention, and post 6-weeks of intervention. At baseline over a period of 6 weeks.
Primary Change from Baseline Pulse Pressure at 6 weeks. Pulse pressure will be measured at baseline (before intervention begin), after 3 weeks of intervention, and post 6-weeks of intervention. At baseline over a period of 6 weeks.
Secondary Change from Baseline Body Mass Index at 6 weeks. Body mass index (BMI) will be measured at baseline (before intervention begin), after 3 weeks of intervention, and post 6-weeks of intervention. At baseline over a period of 6 weeks.
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