ExerciseexerciseNCT03637985
Effect of 12 Weeks of Resistive Exercises Versus Aerobic Exercises in Overweight Hypertensive Postmenopausal Women
A study testing resistive exercise and aerobic exercise in form of treadmill walking in people with Exercise, run by Cairo University at 1 site in Egypt.
Trial summary
Sixty postmenopausal women participated in this study from gynecological outpatient clinic, at Al-Zahra universal Hospital, Al Azhar University, and Cairo. They were first diagnosed to be hypertensive in their early postmenopausal period .Their blood pressure ranged between 140/90mmHg to 170/105mmHg, their ages ranged… Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Exercise
- What is being tested?
- resistive exercise and aerobic exercise in form of treadmill walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Aug 2018
- 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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women diagnosed as essential hypertension.
- All women must be in their early postmenopausal period
Who cannot join
- Lesion to higher centers leading to hypertension (embolism)
- any cardiovascular disease
- premature menopause
- surgical menopause
- severe hypertension
- diabetic
- under treatment of hormonal therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise and Menopausal Hypertension
Sixty postmenopausal women participated in this study from gynecological outpatient clinic, at Al-Zahra universal Hospital, Al Azhar University, and Cairo. They were first diagnosed to be hypertensive in their early postmenopausal period .Their blood pressure ranged between 140/90mmHg to 170/105mmHg, their ages ranged from 50 to 60 years and their body mass index ranged from 30:35 kg/m2.
Read the detailed description
The participants were divided randomly according to closed envelop into three equal groups in number: Group A (RE) consisted of twenty women who participated in the resistive exercise program. Group B (AE) group: consisted of twenty women who participated in an aerobic exercise program. All patients in both groups (A \& B) participated in the exercises three times per week for twelve weeks and every session lasted for 45 min and continues their antihypertensive medication
- Conditions
- Exercise
- Being tested
- resistive exercise, aerobic exercise in form of treadmill walking
- Keywords
- resistive exercises, aerobic, Menopause, hypertension
- Medical subject headings
- Motor Activity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistive exerciseDevice
resistive exercise by elastic band for 12 weeks
aerobic exercise in form of treadmill walkingDevice
aerobic exercise in form of treadmill walking for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| resistive exercise | Experimental | resistive exercises using elastic band(Thera Band) Sets were at moderate intensity, 8-10 repetitions for every motion for 12 weeks Receives: Device: resistive exercise |
| Aerobic exercise | Experimental | Aerobic exercise in form of treadmill walking for 45 minutes for 12 weeks Receives: Device: aerobic exercise in form of treadmill walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in the systolic blood pressure
using the mercury column sphygmomanometer
Measured: 12 weeks
Secondary outcomes (1)
Assessment of changes in the diastolic blood pressure
using the mercury column sphygmomanometer
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Sep 2017
- Primary completion30 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
- Investigators
- ghada E elrefaye, Professor, Principal investigator, Assistant professor of physical therapy for women's health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637985
- Sponsor's protocol ID
- CairoU89
- Acronym
- exercise
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: a randomized controlled trial to determine and compare effect of 12 weeks of resistive exercises versus aerobic exercises in treatment of postmenopausal hypertension
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Menopausal Hypertension
- ClinicalTrials.gov ID
- NCT03637985
- Acronym / sponsor ID
- exercise / CairoU89
- Conditions
- Exercise
- Keywords
- resistive exercises, aerobic, Menopause, hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 20 Aug 2018 (actual)
- 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.
Sixty postmenopausal women participated in this study from gynecological outpatient clinic, at Al-Zahra universal Hospital, Al Azhar University, and Cairo. They were first diagnosed to be hypertensive in their early postmenopausal period .Their blood pressure ranged between 140/90mmHg to 170/105mmHg, their ages ranged from 50 to 60 years and their body mass index ranged from 30:35 kg/m2.
Detailed description
The participants were divided randomly according to closed envelop into three equal groups in number: Group A (RE) consisted of twenty women who participated in the resistive exercise program. Group B (AE) group: consisted of twenty women who participated in an aerobic exercise program. All patients in both groups (A \& B) participated in the exercises three times per week for twelve weeks and every session lasted for 45 min and continues their antihypertensive medication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistive exercise | Experimental | Device: resistive exerciseresistive exercises using elastic band(Thera Band) Sets were at moderate intensity, 8-10 repetitions for every motion for 12 weeks |
| Aerobic exercise | Experimental | Device: aerobic exercise in form of treadmill walkingAerobic exercise in form of treadmill walking for 45 minutes for 12 weeks |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All women diagnosed as essential hypertension.
- All women must be in their early postmenopausal period
Key exclusion criteria (7 listed)
- Lesion to higher centers leading to hypertension (embolism)
- any cardiovascular disease
- premature menopause
- surgical menopause
- severe hypertension
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 |
|---|---|---|
| resistive exerciseresistive exercise by elastic band for 12 weeks | Device | resistive exercise |
| aerobic exercise in form of treadmill walkingaerobic exercise in form of treadmill walking for 12 weeks | Device | Aerobic exercise |
Primary outcome
Assessment of changes in the systolic blood pressure
Time frame: 12 weeks
using the mercury column sphygmomanometer
1 secondary outcome
Assessment of changes in the diastolic blood pressure
Time frame: 12 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 20 Aug 2018.
- Individual participant dataSharing planned: Yes. a randomized controlled trial to determine and compare effect of 12 weeks of resistive exercises versus aerobic exercises in treatment of postmenopausal hypertension
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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.
ghada E elrefaye, Professor principal investigator
Assistant professor of physical therapy for women's health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistive exercise and aerobic exercise in form of treadmill walking in people with Exercise, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 7 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 20 Aug 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 Egypt. 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?
Assessment of changes in the systolic blood pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2018.