Arterial StiffnessNCT04862754
Effect of Interval Training on Arterial Stiffness in Women With Hypertension
A study testing interval training exercise in people with Arterial Stiffness, run by Cairo University at 1 site in Egypt.
Trial summary
this study is aiming to assess the chronic effect of the interval training program on arterial stiffness in women with hypertension Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Arterial Stiffness
- What is being tested?
- interval training exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2021to 15 Apr 2021
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- physically inactive
- BMI 30-40
- Stage 1 and 2 hypertension
- Elevated BP as systolic BP ≥130 mm Hg and/or diastolic BP ≥85 mm Hg measured at the brachial artery.
Who cannot join
- Medications known to affect weight or appetite
- Any disease associated with exercise intolerance.
- Women were taking hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
this study is aiming to assess the chronic effect of the interval training program on arterial stiffness in women with hypertension
- Conditions
- Arterial Stiffness
- Being tested
- interval training exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interval training exerciseOther
interval training exercise
| Study group | Role | What they receive |
|---|---|---|
| interval training | Experimental | Aerobic interval training. It consisted of a modified interval cycle ergometer training program (3 days a week for 8 weeks). AIT consisted of 8 min warm up, followed by four times of 4-min intervals with HR at 80% of submaximal predetermined HR, with active phases of 3 min of cycling at 60% of submaximal predetermined HR. The exercise session was terminated by 5 min cool down Receives: Other: interval training exercise |
| medical treatment | No intervention | hypertensive medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central arterial stiffness measurements (Pulse Wave Velocity [PWV], augmentation index )
Pulse wave analysis (PWA) of the women in the two groups: pre and post treatment for pulse wave velocity (PWV) and augmentation index(AIx)
Pulse Wave Velocity [PWV], augmentation index (AIx @75HR) and resting heart rate were measured using analysis equipment which called Non-invasive blood pressure measurement system using "Mobil-O-Graph 24h PWA " with Hypertension Management Software Client Server (HMS-CS 4.3). PWA was performed using an oscillometric Mobil-O-Graph R 24 h PWA Monitor device (I.E.M GmbH, Germany) with integrated ARCSolver® software
Measured: two months
Secondary outcomes (3)
blood lipid profile
blood analysis will be used to measure lipid profile (high and low-density lipoprotein, cholesterol, triglyceride)
Measured: two months
interleukin 6
blood analysis will be used to measure interleukin 6
Measured: two months
blood pressure (systolic and diastolic)
resting Blood pressure was monitored from the right arm using an automated digital electronic BP monitor (Omron digital BP monitor, Model 11 EM 403c; Tokyo Japan).
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start25 Jan 2021
- Primary completion30 Mar 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies 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
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862754
- Sponsor's protocol ID
- P.T REC/012/003094.
- Status last verified
- Mar 2022
- First submitted
- 12 Jan 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interval Training on Arterial Stiffness in Women With Hypertension
- ClinicalTrials.gov ID
- NCT04862754
- Acronym / sponsor ID
- P.T REC/012/003094.
- Conditions
- Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 28 Apr 2021 (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.
this study is aiming to assess the chronic effect of the interval training program on arterial stiffness in women with hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interval training | Experimental | Other: interval training exerciseAerobic interval training. It consisted of a modified interval cycle ergometer training program (3 days a week for 8 weeks). AIT consisted of 8 min warm up, followed by four times of 4-min intervals with HR at 80% of submaximal predetermined HR, with active phases of 3 min of cycling at 60% of submaximal predetermined HR. The exercise session was terminated by 5 min cool down |
| medical treatment | No intervention | –hypertensive medication |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- physically inactive
- BMI 30-40
- Stage 1 and 2 hypertension
- Elevated BP as systolic BP ≥130 mm Hg and/or diastolic BP ≥85 mm Hg measured at the brachial artery.
Key exclusion criteria (3 listed)
- Medications known to affect weight or appetite
- Any disease associated with exercise intolerance.
- Women were taking hormone replacement therapy
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 |
|---|---|---|
| interval training exerciseinterval training exercise | Other | interval training |
Primary outcome
Central arterial stiffness measurements (Pulse Wave Velocity [PWV], augmentation index )
Time frame: two months
Pulse wave analysis (PWA) of the women in the two groups: pre and post treatment for pulse wave velocity (PWV) and augmentation index(AIx) Pulse Wave Velocity [PWV], augmentation index (AIx @75HR) and resting heart rate were measured using analysis equipment which called Non-invasive blood pressure measurement system using "Mobil-O-Graph 24h PWA " with Hypertension Management Software Client Server (HMS-CS 4.3). PWA was performed using an oscillometric Mobil-O-Graph R 24 h PWA Monitor device (I.E.M GmbH, Germany) with integrated ARCSolver® software
3 secondary outcomes
blood lipid profile
Time frame: two months
interleukin 6
Time frame: two months
blood pressure (systolic and diastolic)
Time frame: two months
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 15 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interval training exercise in people with Arterial Stiffness, 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 4 inclusion and 3 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 15 Mar 2022. 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?
Central arterial stiffness measurements (Pulse Wave Velocity [PWV], augmentation index ) (time frame: two months). 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 15 Mar 2022.