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Clinical Trials/NCT05533268
NCT05533268CompletedNot Applicable

Efficacy of Mental and Physical Training on Blood Pressure and Resting Heart Rate Among Physically Inactive Young Adults With Elevated and High Blood Pressure

Universiti Tunku Abdul Rahman2 sites in 1 country62 target enrollmentStarted: October 25, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
2
Primary Endpoint
Change from Baseline Diastolic Blood Pressure at 6 weeks.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

Outcome assessor will not know about grouping of the participants.

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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 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 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.

Secondary Outcomes

  • Change from Baseline Body Mass Index at 6 weeks.(At baseline over a period of 6 weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Imtiyaz Ali Mir

Principal Investigator

Universiti Tunku Abdul Rahman

Study Sites (2)

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