NCT03029767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2017

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

January 20, 2017

Last Update Submit

November 22, 2018

Conditions

Keywords

HypertensionAnthropometryAerobic exerciseResistance exercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 ]

Study Arms (4)

Aerobic exercise

EXPERIMENTAL

Aerobic exercise training will be carried out as an intervention activity

Other: Aerobic exercise .

Resistance exercise

EXPERIMENTAL

Resistance exercise training will be conducted as an intervention activity

Other: Resistance exercise

Aerobic and resistance exercise

EXPERIMENTAL

Aerobic and resistance training will be implemented

Other: Aerobic and resistance exercise

Control group

NO INTERVENTION

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

Interventions

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.

Also known as: Non pharmacological
Aerobic 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.

Also known as: Non pharmacological
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.

Also known as: Non pharmacological
Aerobic and resistance exercise

Eligibility Criteria

Age31 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawassa University Referral Hospital

Awasa, Southern Nations Nationality Peoples Region, Ethiopia

Location

Related Publications (1)

  • 1. Addo J, Smeeth L, Leon DA. Hypertension in sub Saharan Africa: a systematic review. Hypertension. 50(6):1012-8,2007. [PubMed/17954720] 2. Bacon SL, Sherwood A, Hinderliter A, Blumenthal JA. Effects of exercise, diet and weight loss on high blood pressure. Sports Medicine 35 (5), 307-316,2004. [PubMed/15107009] 3. Banz W, Maher M, Thompson W. Effects of resistance versus aerobic training on coronary artery disease risk factors. Exp Biol Med. 228(4):434-40,2003. [PubMed/12671188] 4. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Jone JR, Materson BJ, Oparil S, Wright JT, Roccella EJ. Seventh Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure: the JNC 7 report.JAMA 289 (19):2560-72, 2003. [PubMed/12748199] 5. Cornelissen V, Fagard R. Effect of resistance training on resting blood pressure: a meta- analysis of randomized controlled trials. J Hypertens 23(2):251-9, 2005. [PubMed/15662209] 6. Cornelissen V, Fagard R. Effects of endurance training on blood pressure, blood pressure-regulating mechanisms, and cardiovascular risk factors. Hypertension 46 (4):667-75, 2005[PubMed/16157788] 7. Fagard RH, Cornelissen VA. Effect of exercise on blood pressure control in Hypertensive patients. Eur J Cardiovasc Prev Rehabil. 14:12-7, 2007. [PubMed/17301622] 8. Fagard RH. Exercise characteristics and the blood pressure response to dynamic physical training. Med Sci Sports Exerc 33: S484-492,2001. [PubMed/11427774] 9. Guidry, M.A., Blanchard ,B.E., Thompson ,P.D., Maresh, C.M., Seip, R.L., &Taylor, A.L. (2006). The influence of short and long duration on the blood pressure response to an acute bout of dynamic exercise. Am Heart J 151:1322.e5-12. [PubMed/16781245] 10. World Health Organization . Obesity: Preventing and Managing the Global Epidemic. WHO Technical Report 2000( 894). Geneva. 11. World Health Organization (2002). The world health report 2002: reducing risks, promoting healthy life. WHO, Geneva. 12. World Health Organization . The world health report 2002: reducing risks, promoting healthy life. WHO, Geneva 2000. 13. World Health Organization (WHO). A global brief on hypertension world health day. Geneva 2013. 14. Ha CH, So WY. Effects of combined exercise training on body composition and metabolic syndrome factors. Iran J Public Health. 41 (8):20-6,2012.[ PMC3469031]

    RESULT

MeSH Terms

Conditions

Hypertension

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Mitiku D Abebe, MSc

    College of Natural and Computational Sciences,Mekelle University Mekelle University

    PRINCIPAL INVESTIGATOR
  • Soumatra K Mondal, PhD

    College of Natural and Computational Sciences, Mekelle University Mekelle University

    STUDY DIRECTOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mitiku Daimo PhD scholar

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 24, 2017

Study Start

February 20, 2017

Primary Completion

June 17, 2017

Study Completion

June 17, 2017

Last Updated

November 26, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

Abstract of the study and consent format

Locations