- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05533268
Effect of Mental and Physical Training on Blood Pressure
January 26, 2023 updated by: Imtiyaz Ali Mir, Universiti Tunku Abdul Rahman
Efficacy of Mental and Physical Training on Blood Pressure and Resting Heart Rate Among Physically Inactive Young Adults With Elevated and High Blood Pressure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Selangor
-
Kajang, Selangor, Malaysia, 43000
- Universiti Tunku Abdul Rahman
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mental Training
mindfulness meditation for 6-weeks.
|
Mental training (guided mindfulness meditation by Jon Kabat-Zinn for 20 minutes, 3 times per week.
|
|
Experimental: Physical Training
Continuous moderate-intensity training for 6-weeks.
|
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.
|
|
Experimental: Mental and Physical Training
Combination of mindfulness meditation and continuous moderate-intensity training for 6 weeks.
|
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.
|
|
Active Comparator: DASH Diet Plan
Dietary Approaches to Stop Hypertension for 6-weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Systolic Blood Pressure at 6 weeks.
Time Frame: At baseline over a period of 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.
|
|
Change from Baseline Diastolic Blood Pressure at 6 weeks.
Time Frame: At baseline over a period of 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.
|
|
Change from Baseline Mean Arterial Pressure at 6 weeks.
Time Frame: At baseline over a period of 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.
|
|
Change from Baseline Resting Heart Rate at 6 weeks.
Time Frame: At baseline over a period of 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.
|
|
Change from Baseline Pulse Pressure at 6 weeks.
Time Frame: At baseline over a period of 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Body Mass Index at 6 weeks.
Time Frame: At baseline over a period of 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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2022
Primary Completion (Actual)
January 18, 2023
Study Completion (Actual)
January 19, 2023
Study Registration Dates
First Submitted
September 5, 2022
First Submitted That Met QC Criteria
September 5, 2022
First Posted (Actual)
September 9, 2022
Study Record Updates
Last Update Posted (Estimate)
January 30, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAP vs DASH Diet
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
IDP will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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