Post Menopausal Obese WomenNCT04676074
Effect of Upper Limb Ergometer on the AIP in Post Menopausal Obese Women.
A study testing Electronic Upper limb( body) ergometer in people with Post Menopausal Obese Women, run by Cairo University at 1 site in Egypt.
Trial summary
Participants had randomly divided into two equal groups. Group (A) which is the control group receive normal routine medication. Group (B) will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Menopausal Obese Women
- What is being tested?
- Electronic Upper limb( body) ergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2020to 31 Mar 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female aged 45-60 years old.
- class 1 and 2 obesity.
- post menopausal.
- diagnosed as controlled diabetic.
- diagnosed as controlled hypertensive.
Who cannot join
- uncontrolled diabetic.
- uncontrolled hypertensive.
- class 3 and morbid obesity.
- mentally unstable person.
- Any shoulder, hand and elbow orthopedic or neural disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic faculty of physical therapy at Cairo University
Giza, 12613
About this study
Official title: Effect of Upper Limb Ergometer on the Arthrogenic Index of Plasma in Post Menopausal Obese Women.
Participants had randomly divided into two equal groups. Group (A) which is the control group receive normal routine medication. Group (B) will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks.
Read the detailed description
Control group (A):
- Each participant will sign a consent form after receiving a detailed explanation about the procedure.
- A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.
- BMI will been measured body weight(Kg) and height (m2)
- BMI= body weight (Kg)/ height (m2).
- Waist circumference will be measured.
- After one month blood analysis evaluation will be done to record the response to the routine medication.
Training Procedure for group (B):
- Each participant will sign a consent form after receiving a detailed explanation about the procedure.
- A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.
- BMI will been measured body weight(Kg) and height (m2)
- BMI= body weight (Kg)/ height (m2).
- Waist circumference will be measured.
- The maximum heart rate will be determined from Tanaka formula (208- 0.7 *age of the participant)
- Then the exercise load will be determined according heart rate reserve of the participants ( maximum heart rate - resting heart rate).
- Start with sitting resting without any effort for 5 min then Start at a low speed and intensity for 5 minutes to warm up the body.
- Increase the speed and intensity for 10-30 seconds before dropping it back for 2-5 minutes and Repeat according to the intensity.
- Finally, a five minutes of cooling down with no resistance had performed.
- After one month blood analysis evaluation will be done to record the response to the routine medication.
- Conditions
- Post Menopausal Obese Women
- Being tested
- Electronic Upper limb( body) ergometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Upper limb( body) ergometerDevice
Electronic pedal for the upper limb using for training the upper body. Intensity, speed and resistance can be adjusted.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | the participant will not do any exercise program but just they will take the routine medication. |
| study group | Experimental | will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks. Receives: Device: Electronic Upper limb( body) ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein)
Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein)
Measured: after one month of the trial application
Secondary outcomes (2)
Effect of the upper body ergometer on total body weight kg.
Effect of the upper body ergometer on total body weight kg.
Measured: after one month of the trial application
Effect of the upper body ergometer on estimated maximum heart rate(beat/min).
Effect of the upper body ergometer on estimated maximum heart rate(beat/min).
Measured: after one month of the trial application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start15 Nov 2020
- Primary completion15 Feb 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Menopausal Obese WomenStudies 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
- Model description
- Participants had randomly divided into two equal groups. Group (A) which is the control group receive normal routine medication. Group (B) will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Elbanna, Cairo University
- Investigators
- Rana H El Banna, PHD, Principal investigator, Faculty of physical therapy at Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676074
- Sponsor's protocol ID
- Rana Hesham
- Status last verified
- Jun 2021
- First submitted
- 11 Dec 2020
- Last updated
- 8 Jun 2021
- 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 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Upper Limb Ergometer on the Arthrogenic Index of Plasma in Post Menopausal Obese Women.
- ClinicalTrials.gov ID
- NCT04676074
- Acronym / sponsor ID
- Rana Hesham
- Conditions
- Post Menopausal Obese Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 19 Dec 2020 (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.
Participants had randomly divided into two equal groups. Group (A) which is the control group receive normal routine medication. Group (B) will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks.
Detailed description
Control group (A):
- Each participant will sign a consent form after receiving a detailed explanation about the procedure.
- A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.
- BMI will been measured body weight(Kg) and height (m2)
- BMI= body weight (Kg)/ height (m2).
- Waist circumference will be measured.
- After one month blood analysis evaluation will be done to record the response to the routine medication.
Training Procedure for group (B):
- Each participant will sign a consent form after receiving a detailed explanation about the procedure.
- A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.
- BMI will been measured body weight(Kg) and height (m2)
- BMI= body weight (Kg)/ height (m2).
- Waist circumference will be measured.
- The maximum heart rate will be determined from Tanaka formula (208- 0.7 *age of the participant)
- Then the exercise load will be determined according heart rate reserve of the participants ( maximum heart rate - resting heart rate).
- Start with sitting resting without any effort for 5 min then Start at a low speed and intensity for 5 minutes to warm up the body.
- Increase the speed and intensity for 10-30 seconds before dropping it back for 2-5 minutes and Repeat according to the intensity.
- Finally, a five minutes of cooling down with no resistance had performed.
- After one month blood analysis evaluation will be done to record the response to the routine medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants had randomly divided into two equal groups. Group (A) which is the control group receive normal routine medication. Group (B) will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –the participant will not do any exercise program but just they will take the routine medication. |
| study group | Experimental | Device: Electronic Upper limb( body) ergometerwill receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female aged 45-60 years old.
- class 1 and 2 obesity.
- post menopausal.
- diagnosed as controlled diabetic.
- diagnosed as controlled hypertensive.
Key exclusion criteria (5 listed)
- uncontrolled diabetic.
- uncontrolled hypertensive.
- class 3 and morbid obesity.
- mentally unstable person.
- Any shoulder, hand and elbow orthopedic or neural disorders.
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 |
|---|---|---|
| Electronic Upper limb( body) ergometerElectronic pedal for the upper limb using for training the upper body. Intensity, speed and resistance can be adjusted. | Device | study group |
Primary outcome
Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein)
Time frame: after one month of the trial application
Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein)
2 secondary outcomes
Effect of the upper body ergometer on total body weight kg.
Time frame: after one month of the trial application
Effect of the upper body ergometer on estimated maximum heart rate(beat/min).
Time frame: after one month of the trial application
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 8 Jun 2021.
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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.
Rana H El Banna, PHD principal investigator
Faculty of physical therapy at 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 Electronic Upper limb( body) ergometer in people with Post Menopausal Obese Women, 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 5 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 8 Jun 2021. 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?
Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein) (time frame: after one month of the trial application). 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 8 Jun 2021.