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临床试验/NCT03029767
NCT03029767已完成不适用

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

Mekelle University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2017年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Effect of aerobic exercise training (as intervention measures) on resting systolic blood pressure will be assessed.

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
31 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control group

No Intervention

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

Aerobic exercise

Experimental

Aerobic exercise training will be carried out as an intervention activity

干预措施: Aerobic exercise . (Other)

Resistance exercise

Experimental

Resistance exercise training will be conducted as an intervention activity

干预措施: Resistance exercise (Other)

Aerobic and resistance exercise

Experimental

Aerobic and resistance training will be implemented

干预措施: Aerobic and resistance exercise (Other)

结局指标

主要结局

Effect of aerobic exercise training (as intervention measures) on resting systolic blood pressure will be assessed.

时间窗: [ Time Frame: sixteen weeks ]

Change rates of systolic blood pressure among intervention and control groups

次要结局

  • 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 ])
  • 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 ])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mitiku Daimo

Mitiku Daimo PhD scholar

Mekelle University

研究点 (1)

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