ObesityNCT06077552
Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis
A study testing pyramidal training by treadmill in people with Obesity and Atherosclerosis, run by Cairo University at 1 site in Egypt.
Trial summary
The study will be conducted on fifty women with central obesity. Their ages will be from 30-40 years old. They will be selected from Al Hayat specialized Hospital in Cairo, Egypt and The participants will be randomly assigned into two equal groups: Group (A): study group, 25 participants will receive pyramidal… Read more about this study
- Who is it for?
- Ages 30 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Atherosclerosis
- What is being tested?
- pyramidal training by treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Jan 2025
- 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 30 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Fifty women with central obesity. 2) Waist circumference > 88 cm. 3) Their age will be ranged from 30-40years old. 4) Body mass index (BMI) from 30 to 34.9 kg/m2. 5) High normal or abnormal lipid profile (total cholesterol > 200 mg/dl, HDL< 35 mg/dl, or triglycerides >150 mg/dl) and atherogenic index of plasma (AIP) ranges 0.11-0.21 6) HOMA-IR > 2.9 7) They are clinically and medically stable. 8) All participants are sedentary activity level according to physical activity index.
Who cannot join
- 1) Participants with musculoskeletal problems (e.g., Sever osteoarthritis or difficulties in ambulation).
- 2) Participants with uncontrolled pulmonary disease. (e.g., Exaggerated chronic obstructive pulmonary disease, acute asthma).
- 3) Any participants who missed more than two weeks of the program or want to terminate the program.
- 4) Participants with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.
- 5) The participants have hearing impairment or mental disorders. 6) Implanted pacemaker. 7) Diabetes and hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis in Women With Central Obesity
The study will be conducted on fifty women with central obesity. Their ages will be from 30-40 years old. They will be selected from Al Hayat specialized Hospital in Cairo, Egypt and The participants will be randomly assigned into two equal groups:
Group (A): study group, 25 participants will receive pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advices.
Group (B): Control group, 25 participants will receive diet health advices. The subjects will be selected from El Haya specialized Hospital, Cairo.
Read the detailed description
The study will be conducted on fifty women with central obesity. Their ages will be from 30-40 years old. They will be selected from Al Hayat specialized Hospital in Cairo, Egypt and The participants will be randomly assigned into two equal groups:
Group (A): study group, 25 participants will receive pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advices.
Group (B): Control group, 25 participants will receive diet health advices. The subjects will be selected from El Haya specialized Hospital, Cairo. Before starting the procedure the participants target heart rate (THR) will be calculated from Karvonen formula as follow: target heart rate (THR) = maximum heart rate (HRmax) - resting heart rate × intensity + resting heart rate(RHR)(Yabe et al.,2021).
The formula 208-0.7•age yield more precise estimates of HRmax over a wide age range (Nes et al., 2013).
After calculating THR, the study group participants will be on a pyramidal training program of incremental and decremental levels as follow:
The course of the program will be 2 sets of pyramidal training with 10 minutes for rest between them. each set will be 5 levels of incremental and 5 levels of decremental aerobic exercise and each level 2 minutes on a treadmill. All these levels will be ranked according to a percentage from the THR; the ranking will be as follow:
- Level one: will be set as a 20% walking of Karvonen formula.
- Level two: will be set as a 30% running of Karvonen formula.
- Level three: will be set as a 50%running of Karvonen formula.
- Level four: will be set as a 70% running of Karvonen formula.
- Level five: will be set as a 80% running of Karvonen formula The whole program will be 40 minutes with warm up and cool down 5 minutes of stretch exercise for each. Participants will be asked to get on the treadmill and start the program, the therapist is monitoring the heart rate by using a pulse oximeter, and when the participants reach targeted percent of Karvonen formula, the therapist set the treadmill by increasing the speed to enter or start the up next level till reaching the highest level then start the decremental phase of the pyramidal training. The therapist shifts between the level by time or targeted percent of Karvonen formula which comes first.
- Conditions
- Obesity, Atherosclerosis
- Being tested
- pyramidal training by treadmill
- Keywords
- obesity, risk factor, lipid profile
- Medical subject headings
- Obesity, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyramidal training by treadmillOther
pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advises
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advises. Receives: Other: pyramidal training by treadmill |
| control group | No intervention | receive diet health advises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
atherogenic index of plasma
blood analysis
Measured: 8 weeks
Secondary outcomes (4)
Waist circumference
tape measurement
Measured: 8 weeks
Body mass index
measurement weight on height
Measured: 8 weeks
lipid profile
blood analysis
Measured: 8 weeks
insulin resistance
homeostatic model assessment for insulin resistance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Nov 2023
- Primary completion30 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa mahmoud elsayed mahmoud, Cairo University
- Investigators
- Marwa elsayed, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077552
- Sponsor's protocol ID
- P.T.REC/012/004666
- Status last verified
- Feb 2025
- First submitted
- 5 Oct 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: journal publishing article
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis in Women With Central Obesity
- ClinicalTrials.gov ID
- NCT06077552
- Acronym / sponsor ID
- P.T.REC/012/004666
- Conditions
- Obesity, Atherosclerosis
- Keywords
- obesity, risk factor, lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 11 Oct 2023 (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.
The study will be conducted on fifty women with central obesity. Their ages will be from 30-40 years old. They will be selected from Al Hayat specialized Hospital in Cairo, Egypt and The participants will be randomly assigned into two equal groups:
Group (A): study group, 25 participants will receive pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advices.
Group (B): Control group, 25 participants will receive diet health advices. The subjects will be selected from El Haya specialized Hospital, Cairo.
Detailed description
The study will be conducted on fifty women with central obesity. Their ages will be from 30-40 years old. They will be selected from Al Hayat specialized Hospital in Cairo, Egypt and The participants will be randomly assigned into two equal groups:
Group (A): study group, 25 participants will receive pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advices.
Group (B): Control group, 25 participants will receive diet health advices. The subjects will be selected from El Haya specialized Hospital, Cairo. Before starting the procedure the participants target heart rate (THR) will be calculated from Karvonen formula as follow: target heart rate (THR) = maximum heart rate (HRmax) - resting heart rate × intensity + resting heart rate(RHR)(Yabe et al.,2021).
The formula 208-0.7•age yield more precise estimates of HRmax over a wide age range (Nes et al., 2013).
After calculating THR, the study group participants will be on a pyramidal training program of incremental and decremental levels as follow:
The course of the program will be 2 sets of pyramidal training with 10 minutes for rest between them. each set will be 5 levels of incremental and 5 levels of decremental aerobic exercise and each level 2 minutes on a treadmill. All these levels will be ranked according to a percentage from the THR; the ranking will be as follow:
- Level one: will be set as a 20% walking of Karvonen formula.
- Level two: will be set as a 30% running of Karvonen formula.
- Level three: will be set as a 50%running of Karvonen formula.
- Level four: will be set as a 70% running of Karvonen formula.
- Level five: will be set as a 80% running of Karvonen formula The whole program will be 40 minutes with warm up and cool down 5 minutes of stretch exercise for each. Participants will be asked to get on the treadmill and start the program, the therapist is monitoring the heart rate by using a pulse oximeter, and when the participants reach targeted percent of Karvonen formula, the therapist set the treadmill by increasing the speed to enter or start the up next level till reaching the highest level then start the decremental phase of the pyramidal training. The therapist shifts between the level by time or targeted percent of Karvonen formula which comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: pyramidal training by treadmillpyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advises. |
| control group | No intervention | –receive diet health advises. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) Fifty women with central obesity. 2) Waist circumference > 88 cm. 3) Their age will be ranged from 30-40years old. 4) Body mass index (BMI) from 30 to 34.9 kg/m2. 5) High normal or abnormal lipid profile (total cholesterol > 200 mg/dl, HDL< 35 mg/dl, or triglycerides >150 mg/dl) and atherogenic index of plasma (AIP) ranges 0.11-0.21 6) HOMA-IR > 2.9 7) They are clinically and medically stable. 8) All participants are sedentary activity level according to physical activity index.
Key exclusion criteria (5 listed)
- 1) Participants with musculoskeletal problems (e.g., Sever osteoarthritis or difficulties in ambulation).
- 2) Participants with uncontrolled pulmonary disease. (e.g., Exaggerated chronic obstructive pulmonary disease, acute asthma).
- 3) Any participants who missed more than two weeks of the program or want to terminate the program.
- 4) Participants with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.
- 5) The participants have hearing impairment or mental disorders. 6) Implanted pacemaker. 7) Diabetes and 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 |
|---|---|---|
| pyramidal training by treadmillpyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advises | Other | experimental group |
Primary outcome
atherogenic index of plasma
Time frame: 8 weeks
blood analysis
4 secondary outcomes
Waist circumference
Time frame: 8 weeks
Body mass index
Time frame: 8 weeks
lipid profile
Time frame: 8 weeks
insulin resistance
Time frame: 8 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 18 Feb 2025.
- Individual participant dataSharing planned: Yes. journal publishing article
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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.
Marwa elsayed, PhD principal investigator
Cairo 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 pyramidal training by treadmill in people with Obesity and Atherosclerosis, 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 1 inclusion and 5 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 18 Feb 2025. 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?
atherogenic index of plasma (time frame: 8 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 18 Feb 2025.