Clinical trial NCT03029767: Effect of Exercise on Selected Anthropometric,Biochemical and Physiological Variables Among Hypertensive Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Anthropometry
Aerobic exercise
Resistance exercise
Lead sponsor: Mekelle University
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 92
Sex: ALL
Minimum age (years): 31
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Effect of aerobic exercise training (as intervention measures) on resting systolic blood pressure will be assessed.
timeFrame: [ Time Frame: sixteen weeks ]
Secondary outcomes:
measure: Effect of combined aerobic and resistance training on the reduction of body mass index among the hypertensive patients will be assessed
timeFrame: [ Time Frame: Sixteen weeks ]
measure: Effect of combined aerobic and resistance training on the increasement of HDL-c level among the hypertensive patients will be assessed
timeFrame: [ Time Frame: Sixteen weeks ]
Other outcomes:
Locations:
city: Hawassa
country: Ethiopia
facility: Hawassa University Referral Hospital
state: Southern Nations Nationality Peoples Region
Study officials:
affiliation: College of Natural and Computational Sciences,Mekelle University Mekelle University
name: Mitiku D Abebe, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Natural and Computational Sciences, Mekelle University Mekelle University
name: Soumatra K Mondal, PhD
role: STUDY_DIRECTOR
affiliation: College of Health Sciences, Mekelle University
name: Mahmud Ab Mahmud, PhD
role: STUDY_CHAIR
affiliation: College of Natural and Computational Sciences, Mekelle University
name: Palani B Kumar, PhD
role: STUDY_CHAIR
References:
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