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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Malaysia
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mental Training
mindfulness meditation for 6-weeks.
Other: Mental training
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.
Other: 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.
Experimental: Mental and Physical Training
Combination of mindfulness meditation and continuous moderate-intensity training for 6 weeks.
Other: 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.
Active Comparator: DASH Diet Plan
Dietary Approaches to Stop Hypertension for 6-weeks.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Tunku Abdul Rahman

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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