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

Sponsor
Mekelle University (Other)
Overall Status
Completed
CT.gov ID
NCT03029767
Collaborator
(none)
92
Enrollment
1
Location
4
Arms
3.8
Actual Duration (Months)
23.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aerobic exercise .
  • Other: Resistance exercise
  • Other: Aerobic and resistance exercise
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 20, 2017
Actual Primary Completion Date :
Jun 17, 2017
Actual Study Completion Date :
Jun 17, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aerobic exercise

Aerobic exercise training will be carried out as an intervention activity

Other: Aerobic exercise .
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.
Other Names:
  • Non pharmacological

    		•
    Experimental: Resistance exercise

    Resistance exercise training will be conducted as an intervention activity

    Other: Resistance exercise
    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.
    Other Names:
  • Non pharmacological

    		•
    Experimental: Aerobic and resistance exercise

    Aerobic and resistance training will be implemented

    Other: Aerobic and resistance exercise
    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.
    Other Names:
  • Non pharmacological

    		•
    No Intervention: Control group

    standard or usual activity carried out.Additional intervention will not be given.

    Outcome Measures

    Primary Outcome Measures

    1. Effect of aerobic exercise training (as intervention measures) on resting systolic blood pressure will be assessed. [[ Time Frame: sixteen weeks ]]

      Change rates of systolic blood pressure among intervention and control groups

    Secondary Outcome Measures

    1. Effect of combined aerobic and resistance training on the reduction of body mass index among the hypertensive patients will be assessed [[ Time Frame: Sixteen weeks ]]

      Body mass index reduction changes among intervention and control groups

    2. Effect of combined aerobic and resistance training on the increasement of HDL-c level among the hypertensive patients will be assessed [[ Time Frame: Sixteen weeks ]]

      HDL-C level changes among intervention and control groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    31 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hawassa University Referral Hospital Hawassa Southern Nations Nationality Peoples Region Ethiopia

    Sponsors and Collaborators

    • Mekelle University

    Investigators

    • Principal Investigator: Mitiku D Abebe, MSc, College of Natural and Computational Sciences,Mekelle University Mekelle University
    • Study Director: Soumatra K Mondal, PhD, College of Natural and Computational Sciences, Mekelle University Mekelle University
    • Study Chair: Mahmud Ab Mahmud, PhD, College of Health Sciences, Mekelle University
    • Study Chair: Palani B Kumar, PhD, College of Natural and Computational Sciences, Mekelle University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitiku Daimo, Mitiku Daimo PhD scholar, Mekelle University
    ClinicalTrials.gov Identifier:
    NCT03029767
    Other Study ID Numbers:
    • 213.55.94.37
    First Posted:
    Jan 24, 2017
    Last Update Posted:
    Nov 26, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Mitiku Daimo, Mitiku Daimo PhD scholar, Mekelle University
    Hypertension
    Anthropometry
    Aerobic exercise
    Resistance exercise
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Nov 26, 2018