Effect of Exercise on Selected Anthropometric,Biochemical and Physiological Variables Among Hypertensive Patients

Study Overview
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Brief Summary
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Hypertension is the most common risk factor for development of stroke, congestive heart failure chronic kidney disease, and coronary artery disease in Sub Saharan Africa. The prevalence of hypertension will increase by 2025 in most parts of the world including Ethiopia according to World Health Organization. Physical inactivity has been identified as a stronger predictor of chronic diseases such as hypertension. Exercise as a lifestyle modification is beneficial to a wide variety of health conditions, specific to hypertension; the benefits of exercise have been promoted by a number of organizations and agencies including World Health Organization. According to the knowledge of the investigator there are no research works in relation to aerobic and resistance exercise effects among hypertensive patients generally in Ethiopia, and particularly in the area selected for the present research. Therefore the aim of this study is to assess the effect of aerobic and resistance exercises on selected anthropometric, biochemical and physiological variables among hypertensive patients in Hawassa University Referral Hospital.

Detailed Description
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For eligible participants the requirements of the study will be explained and agree voluntarily to undergo the training and testing program. During orientation for each participant the risks, purpose, procedures and confidentiality of the requirement of the experiment testing as well as training protocol will be explained thoroughly prior to their written informed consent in their local language, and they have a full right to refuse from participating in this research or they have also the full right to withdraw from this study at any time they wish. After acquisition of informed consent and exclusion criteria eligible participants will be randomized to one of four groups. Sequence allocation will be done by an individual who do not know and have no contact with the study participants . Statistical analyses will be done using Statistical Package for Social Science (SPSS Version 20). One-way analyses of variance (ANOVA) will be used to assess differences between initial values of the four groups on all the variables measured. In addition, the effect of the experimental treatments on the anthropometric, biochemical and physiological variables will be examined by using two-way analysis of variance (ANOVA).

Official Title
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Effect of Aerobic and Resistance Exercise on Selected Anthropometric Biochemical and Physiological Variables Among Hypertensive Patients in Hawassa University Referral Hospital, Southern Ethiopia: a Parallel Randomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Other: Aerobic exercise .
* Other: Resistance exercise
* Other: Aerobic and resistance exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertensive patients who will give a written consent to participate in the study Hypertensive patients who are going to stay in the area throughout the study period Hypertensive patients between the age range of 31 and 45 years old with essential mild hypertension (systolic blood pressure between 140-159 mmHg and diastolic blood pressure between 90 and 99 mm Hg) participants not participated in structured physical exercises for previous 3 months patients who are on single anti-hypertensive medication or unmedicated Body mass index(BMI) 18.5kg/m2-29.9kg/m2 Exclusion Criteria: participants who involved in any exercise program prior to study pregnant women women who are taking contraceptive drugs Participants who are taking lipid lowering drugs participants who are taking any medications except single anti-hypertensive medication participants with organ damage, secondary hypertension patients with known liver problem patients with renal disease ,heart disease, brain disease participants with age less than 31 and greater than 45 years diabetic patients

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise<br>Aerobic exercise training will be carried out as an intervention activity | Other: Aerobic exercise .<br>* The aerobic exercise group will perform brisk walking. Intensity of the aerobic exercise program will be progressively increased throughout the 16-week program. Intensity of aerobic exercise will be 40-65% of maximum heart rate , which is low to moderate.Duration of each session will be 45 minutes. Aerobic exercise will be performed 3 days per week.<br>* Other names: Non pharmacological;|
| Experimental: Resistance exercise<br>Resistance exercise training will be conducted as an intervention activity | Other: Resistance exercise<br>* The resistance exercise group will perform 8 different exercises. Frequency of exercises per week is 3 days and duration of each exercise session is 45minutes. Interval rest among different exercises is 1minute.The intensity and repetition of resistance exercises is progressive. Participants will be exercised at 30% intensity (low intensity) for upper body and 50% intensity (moderate intensity) repetition voluntary maximum for lower body. Progressive, dynamic and rhythmical, alternative to upper-body and lower-body works and circuit resistance training of low to moderate intensity exercises will be executed.<br>* Other names: Non pharmacological;|
| Experimental: Aerobic and resistance exercise<br>Aerobic and resistance training will be implemented | Other: Aerobic and resistance exercise<br>* The aerobic and resistance exercise group will perform 23 minutes aerobic exercises and 22 minutes resistance exercises. The exercises will be performed three days per week . Intensity of aerobic and resistance exercise group for aerobic and resistance exercises are similar with intensity of aerobic group and resistance group exercises respectively.<br>* Other names: Non pharmacological;|
| No Intervention: Control group<br>standard or usual activity carried out.Additional intervention will not be given. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of aerobic exercise training (as intervention measures) on resting systolic blood pressure will be assessed. | Change rates of systolic blood pressure among intervention and control groups | [ Time Frame: sixteen weeks ] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of combined aerobic and resistance training on the reduction of body mass index among the hypertensive patients will be assessed | Body mass index reduction changes among intervention and control groups | [ Time Frame: Sixteen weeks ] | 
| Effect of combined aerobic and resistance training on the increasement of HDL-c level among the hypertensive patients will be assessed | HDL-C level changes among intervention and control groups | [ Time Frame: Sixteen weeks ] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Anthropometry, Aerobic exercise, Resistance exercise