Elevated Blood PressureNCT05533268
Effect of Mental and Physical Training on Blood Pressure
A study testing Mental training, Physical training and Mental & physical training in people with Elevated Blood Pressure, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Elevated Blood Pressure
- What is being tested?
- Mental training, Physical training and Mental & physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteMalaysia
- Study dates
- 25 Oct 2022to 19 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Elevated Blood Pressure
- Being tested
- Mental training, Physical training, Mental & physical training, DASH diet
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental trainingOther
Mental training (guided mindfulness meditation by Jon Kabat-Zinn for 20 minutes, 3 times per week.
Physical trainingOther
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 trainingOther
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 dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mental Training | Experimental | mindfulness meditation for 6-weeks. Receives: Other: Mental training |
| Physical Training | Experimental | Continuous moderate-intensity training for 6-weeks. Receives: Other: Physical training |
| Mental and Physical Training | Experimental | Combination of mindfulness meditation and continuous moderate-intensity training for 6 weeks. Receives: Other: Mental & physical training |
| DASH Diet Plan | Active comparator | Dietary Approaches to Stop Hypertension for 6-weeks. Receives: Other: DASH diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline over a period of 6 weeks.
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.
Measured: At baseline over a period of 6 weeks.
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.
Measured: At baseline over a period of 6 weeks.
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.
Measured: At baseline over a period of 6 weeks.
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.
Measured: At baseline over a period of 6 weeks.
Secondary outcomes (1)
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.
Measured: At baseline over a period of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start25 Oct 2022
- Primary completion18 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imtiyaz Ali Mir, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533268
- Sponsor's protocol ID
- MAP vs DASH Diet
- Status last verified
- Jan 2023
- First submitted
- 5 Sep 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will not be shared.
Publications
Mir IA, Humayra S, John AT, Wan CH, Toh XY. Efficacy of mental and physical training on blood pressure and resting heart rate among physically inactive young adults with elevated blood pressure: a randomized controlled trial. Sci Rep. 2026 Jul 8;16(1):24026. doi: 10.1038/s41598-026-60452-7.
PubMed 42420366
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05533268
- Acronym / sponsor ID
- MAP vs DASH Diet
- Conditions
- Elevated Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mental Training | Experimental | Other: Mental trainingmindfulness meditation for 6-weeks. |
| Physical Training | Experimental | Other: Physical trainingContinuous moderate-intensity training for 6-weeks. |
| Mental and Physical Training | Experimental | Other: Mental & physical trainingCombination of mindfulness meditation and continuous moderate-intensity training for 6 weeks. |
| DASH Diet Plan | Active comparator | Other: DASH dietDietary Approaches to Stop Hypertension for 6-weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental trainingMental training (guided mindfulness meditation by Jon Kabat-Zinn for 20 minutes, 3 times per week. | Other | Mental Training |
| Physical trainingPhysical 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. | Other | Physical Training |
| Mental & physical trainingMental 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. | Other | Mental and Physical Training |
| DASH dietDASH 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. | Other | DASH Diet Plan |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Change from Baseline Body Mass Index at 6 weeks.
Time frame: At baseline over a period of 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Derived from this study: PubMed 42420366Mir IA, Humayra S, John AT, Wan CH, Toh XY. Efficacy of mental and physical training on blood pressure and resting heart rate among physically inactive young adults with elevated blood pressure: a randomized controlled trial. Sci Rep. 2026 Jul 8;16(1):24026. doi: 10.1038/s41598-026-60452-7.
- Individual participant dataSharing planned: No. IDP will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental training, Physical training and Mental & physical training in people with Elevated Blood Pressure, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Systolic Blood Pressure at 6 weeks. (time frame: At baseline over a period of 6 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05533268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.