HypertensionNCT03029767
Effect of Exercise on Selected Anthropometric,Biochemical and Physiological Variables Among Hypertensive Patients
A study testing Aerobic exercise ., Resistance exercise and Aerobic and resistance exercise in people with Hypertension, run by Mekelle University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 31 to 45 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aerobic exercise ., Resistance exercise and Aerobic and resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEthiopia
- Study dates
- 20 Feb 2017to 17 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Hawassa University Referral Hospital
Awasa, Southern Nations Nationality Peoples Region
About this study
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
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.
Read the 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).
- Conditions
- Hypertension
- Being tested
- Aerobic exercise ., Resistance exercise, Aerobic and resistance exercise
- Keywords
- Hypertension, Anthropometry, Aerobic exercise, Resistance exercise
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise .Other
Also called Non pharmacological
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.
Resistance exerciseOther
Also called Non pharmacological
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.
Aerobic and resistance exerciseOther
Also called Non pharmacological
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Aerobic exercise training will be carried out as an intervention activity Receives: Other: Aerobic exercise . |
| Resistance exercise | Experimental | Resistance exercise training will be conducted as an intervention activity Receives: Other: Resistance exercise |
| Aerobic and resistance exercise | Experimental | Aerobic and resistance training will be implemented Receives: Other: Aerobic and resistance exercise |
| Control group | No intervention | standard or usual activity carried out.Additional intervention will not be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [ 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
Body mass index reduction changes among intervention and control groups
Measured: [ 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
Measured: [ Time Frame: Sixteen weeks ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start20 Feb 2017
- Primary completion17 Jun 2017
- Study completion17 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mekelle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitiku Daimo, Mekelle University
- Investigators
- Mitiku D Abebe, MSc, Principal investigator, College of Natural and Computational Sciences,Mekelle University Mekelle UniversitySoumatra K Mondal, PhD, Study director, College of Natural and Computational Sciences, Mekelle University Mekelle UniversityMahmud Ab Mahmud, PhD, Study chair, College of Health Sciences, Mekelle UniversityPalani B Kumar, PhD, Study chair, College of Natural and Computational Sciences, Mekelle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029767
- Sponsor's protocol ID
- 213.55.94.37
- Status last verified
- Nov 2018
- First submitted
- 20 Jan 2017
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Abstract of the study and consent format
Publications
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]
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03029767
- Acronym / sponsor ID
- 213.55.94.37
- Conditions
- Hypertension
- Keywords
- Hypertension, Anthropometry, Aerobic exercise, Resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Mekelle UniversityUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 17 Jun 2017 (actual)
- Study completion
- 17 Jun 2017 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: Aerobic exercise .Aerobic exercise training will be carried out as an intervention activity |
| Resistance exercise | Experimental | Other: Resistance exerciseResistance exercise training will be conducted as an intervention activity |
| Aerobic and resistance exercise | Experimental | Other: Aerobic and resistance exerciseAerobic and resistance training will be implemented |
| Control group | No intervention | –standard or usual activity carried out.Additional intervention will not be given. |
Who may qualify
- Ages
- 31 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise .Also: Non pharmacologicalThe 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 | Aerobic exercise |
| Resistance exerciseAlso: Non pharmacologicalThe 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 | Resistance exercise |
| Aerobic and resistance exerciseAlso: Non pharmacologicalThe 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 | Aerobic and resistance exercise |
Primary outcome
Effect of aerobic exercise training (as intervention measures) on resting systolic blood pressure will be assessed.
Time frame: [ Time Frame: sixteen weeks ]
Change rates of systolic blood pressure among intervention and control groups
2 secondary outcomes
Effect of combined aerobic and resistance training on the reduction of body mass index among the hypertensive patients will be assessed
Time frame: [ 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: [ Time Frame: Sixteen weeks ]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Results publication1. 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]
- Individual participant dataSharing planned: Yes. Abstract of the study and consent format
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitiku D Abebe, MSc principal investigator
College of Natural and Computational Sciences,Mekelle University Mekelle University
Soumatra K Mondal, PhD study director
College of Natural and Computational Sciences, Mekelle University Mekelle University
Mahmud Ab Mahmud, PhD study chair
College of Health Sciences, Mekelle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise ., Resistance exercise and Aerobic and resistance exercise in people with Hypertension, run by Mekelle University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of aerobic exercise training (as intervention measures) on resting systolic blood pressure will be assessed. (time frame: [ Time Frame: sixteen weeks ]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.