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Completed

NCT Number: NCT05533268

Effect of Mental and Physical Training on 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.

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Key information

Conditions

Elevated Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Tunku Abdul Rahman

Kajang, Selangor, 43000, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mental training

Other

Mental training (guided mindfulness meditation by Jon Kabat-Zinn for 20 minutes, 3 times per week.

Physical training

Other

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

Other

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

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universiti Tunku Abdul Rahman

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2022
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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