Effect of Mental and Physical Training on Blood Pressure

NCT05533268 | Completed

• 1 other identifier: MAP vs DASH Diet
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elevated Blood Pressure

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• Change from Baseline Body Mass Index at 6 weeks.

  At baseline over a period of 6 weeks.

Study Arms (4)

Mental Training

EXPERIMENTAL

mindfulness meditation for 6-weeks.

Other: Mental training

Physical Training

EXPERIMENTAL

Continuous moderate-intensity training for 6-weeks.

Other: Physical training

Mental and Physical Training

EXPERIMENTAL

Combination of mindfulness meditation and continuous moderate-intensity training for 6 weeks.

Other: Mental & physical training

DASH Diet Plan

ACTIVE COMPARATOR

Dietary Approaches to Stop Hypertension for 6-weeks.

Other: DASH diet

Interventions

Mental training OTHER

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

Mental Training

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.

Physical Training

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.

Mental and Physical Training

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.

DASH Diet Plan

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Young male adults who are physically inactive.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

Universiti Tunku Abdul Rahman

Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Physical Conditioning, Human; Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will not know about grouping of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: October 25, 2022
• Primary Completion: January 18, 2023
• Study Completion: January 19, 2023
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)