Metabolic SyndromeNCT04635202
Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome
A study testing exercise training on elliptical device in people with Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The growing prevalence of metabolic syndrome (MetS) in the worldwide is becoming a serious health problem and economic burden. MetS has become a crucial risk factor for the development of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- exercise training on elliptical device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2020to 1 Jun 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The MeTS subjects who will have three or more of the following criteria: 1) waist circumference more than 102 cm, triglycerides more than 150 mg/dL, 3) blood pressure (BP) more than 130/85 mmHg, 4) high-density lipoprotein (HDL) less than 40 mg/dL, .
Who cannot join
- Renal, pulmonary, cardiac, vascular, respiratory, hepatic, autoimmune disorders.
- Smoker, addictive, cancer, and alcoholic patients.
- Lower limb arthritis or any orthopaedic problem will hinder the training.
- Participation in any type of sport training in the previous 6 months.
- Pregnant or lactating women.
- Patients with thyroid gland dysfunction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza, Dokki
Ali Ismail, lecturer, 02 01005154209, allooka2012@gmail.com
About this study
Official title: Effect of Elliptical Training on Lipids, Glucose and Insulin Homeostasis in Metabolic Syndrome
The growing prevalence of metabolic syndrome (MetS) in the worldwide is becoming a serious health problem and economic burden. MetS has become a crucial risk factor for the development of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). The rising rates of CVD and diabetes, which are the two leading causes of death. To prevent the progression of MetS to diabetes and CVD, regular physical activity is required.
Elliptical trainer device is a relatively new modality of exercise and is advertised to be superior to a treadmill because of the low joint impact and the more reasonable costs of an elliptical trainer compared to a treadmill. Additional quantitative research is needed to further evaluate the effectiveness of elliptical trainers and the physiological and perceptual responses to the machine.
Read the detailed description
Forty sedentary MeTS patients (from both sexes) will be randomly divided to group A and group B.
-Group A (Elliptical training group): This group (n=20) will receive aerobic training on an elliptical trainer for 16 weeks (3 sessions per week). The session will start with 5 minutes warming up at 50 % of maximal heart rate (MHR), 20-minute continuous ET at 70% of MHR, 12 minutes (4×3) intervals at 90% of MHR with a 3-minute active recovery at 70% of MHR between intervals, and finally 5-minute cool-down period at 50% of MHR.
Group B: this group will continue their normal daily physical activities without any additional training
- Conditions
- Metabolic Syndrome
- Being tested
- exercise training on elliptical device, group B (control group)
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise training on elliptical deviceBehavioural
Also called group A
This group (n=30) will receive aerobic training on an elliptical trainer for 16 weeks (3 sessions per week). The session will start with 5 minutes warming up at 50 % of maximal heart rate (MHR), 20-minute continuous ET at 70% of MHR, 12 minutes (4×3) intervals at 90% of MHR with a 3-minute active recovery at 70% of MHR between intervals, and finally 5-minute cool-down period at 50% of MHR
group B (control group)Behavioural
this group will receive general advises on maintaining physical activities for 16 weeks without any additional supervised training
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | patients (n=30) in this group will receive 16 weeks of elliptical training on elliptical trainer, 3 times per week. the training will start with 5 minutes warming up at 50 % of maximal heart rate (MHR), 20-minute continuous ET at 70% of MHR, 12 minutes (4×3) intervals at 90% of MHR with a 3-minute active recovery at 70% of MHR between intervals, and finally 5-minute cool-down period at 50% of MHR Receives: Behavioral: exercise training on elliptical device |
| Group B (control group) | Other | patients (n=30) in this group will receive general advises on maintaining physical activities Receives: Behavioral: group B (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides
Triglycerides is one of lipid profile indicators
Measured: It will be measured after 16 weeks of training
high density lipoprotein
high density lipoprotein is one of lipid profile indicators
Measured: It will be measured after 16 weeks of training
Secondary outcomes (9)
Systolic blood pressure
It will be measured via Sphygmomanometer
Measured: It will be measured after 16 weeks of training
diastolic blood pressure
It will be measured via Sphygmomanometer
Measured: It will be measured after 16 weeks of training
Fasting blood glucose
It will be measured via a blood glucose meter
Measured: It will be measured after 16 weeks of training
Insulin
it will be measured via a blood sample
Measured: It will be measured after 16 weeks of training
The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance
HOMA-IR = [fasting insulin (μU/mL)
× fasting glucose (mmol)]/22.5
Measured: It will be measured after 16 weeks of training
Waist circumference
it will be measured by inelastic tape at the umbilicus level
Measured: It will be measured after 16 weeks of training
weight
the weight scale will be used
Measured: It will be measured after 16 weeks of training
Leg strength test
will be assessd by leg dynamometer
Measured: It will be measured after 16 weeks of training
% body fat
percentage of body fat composition
Measured: It will be measured after 16 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start9 Sep 2020
- Primary completion15 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635202
- Sponsor's protocol ID
- P.T.REC/012/002896
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Elliptical Training on Lipids, Glucose and Insulin Homeostasis in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04635202
- Acronym / sponsor ID
- P.T.REC/012/002896
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 19 Nov 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.
The growing prevalence of metabolic syndrome (MetS) in the worldwide is becoming a serious health problem and economic burden. MetS has become a crucial risk factor for the development of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). The rising rates of CVD and diabetes, which are the two leading causes of death. To prevent the progression of MetS to diabetes and CVD, regular physical activity is required.
Elliptical trainer device is a relatively new modality of exercise and is advertised to be superior to a treadmill because of the low joint impact and the more reasonable costs of an elliptical trainer compared to a treadmill. Additional quantitative research is needed to further evaluate the effectiveness of elliptical trainers and the physiological and perceptual responses to the machine.
Detailed description
Forty sedentary MeTS patients (from both sexes) will be randomly divided to group A and group B.
-Group A (Elliptical training group): This group (n=20) will receive aerobic training on an elliptical trainer for 16 weeks (3 sessions per week). The session will start with 5 minutes warming up at 50 % of maximal heart rate (MHR), 20-minute continuous ET at 70% of MHR, 12 minutes (4×3) intervals at 90% of MHR with a 3-minute active recovery at 70% of MHR between intervals, and finally 5-minute cool-down period at 50% of MHR.
Group B: this group will continue their normal daily physical activities without any additional training
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Behavioral: exercise training on elliptical devicepatients (n=30) in this group will receive 16 weeks of elliptical training on elliptical trainer, 3 times per week. the training will start with 5 minutes warming up at 50 % of maximal heart rate (MHR), 20-minute continuous ET at 70% of MHR, 12 minutes (4×3) intervals at 90% of MHR with a 3-minute active recovery at 70% of MHR between intervals, and finally 5-minute cool-down period at 50% of MHR |
| Group B (control group) | Other | Behavioral: group B (control group)patients (n=30) in this group will receive general advises on maintaining physical activities |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The MeTS subjects who will have three or more of the following criteria: 1) waist circumference more than 102 cm, triglycerides more than 150 mg/dL, 3) blood pressure (BP) more than 130/85 mmHg, 4) high-density lipoprotein (HDL) less than 40 mg/dL, .
Key exclusion criteria (6 listed)
- Renal, pulmonary, cardiac, vascular, respiratory, hepatic, autoimmune disorders.
- Smoker, addictive, cancer, and alcoholic patients.
- Lower limb arthritis or any orthopaedic problem will hinder the training.
- Participation in any type of sport training in the previous 6 months.
- Pregnant or lactating women.
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 |
|---|---|---|
| exercise training on elliptical deviceAlso: group AThis group (n=30) will receive aerobic training on an elliptical trainer for 16 weeks (3 sessions per week). The session will start with 5 minutes warming up at 50 % of maximal heart rate (MHR), 20-minute continuous ET at 70% of MHR, 12 minutes (4×3) intervals at 90% of MHR with a 3-minute active recovery at 70% of MHR between intervals, and finally 5-minute cool-down period at 50% of MHR | Behavioural | group A |
| group B (control group)this group will receive general advises on maintaining physical activities for 16 weeks without any additional supervised training | Behavioural | Group B (control group) |
Primary outcome
Triglycerides
Time frame: It will be measured after 16 weeks of training
Triglycerides is one of lipid profile indicators
high density lipoprotein
Time frame: It will be measured after 16 weeks of training
high density lipoprotein is one of lipid profile indicators
9 secondary outcomes
Systolic blood pressure
Time frame: It will be measured after 16 weeks of training
diastolic blood pressure
Time frame: It will be measured after 16 weeks of training
Fasting blood glucose
Time frame: It will be measured after 16 weeks of training
Insulin
Time frame: It will be measured after 16 weeks of training
The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance
Time frame: It will be measured after 16 weeks of training
Waist circumference
Time frame: It will be measured after 16 weeks of training
weight
Time frame: It will be measured after 16 weeks of training
Leg strength test
Time frame: It will be measured after 16 weeks of training
% body fat
Time frame: It will be measured after 16 weeks of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
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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.
Ali Ismail, lecturer 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 exercise training on elliptical device in people with Metabolic Syndrome, 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 6 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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglycerides (time frame: It will be measured after 16 weeks of training). The study lists 2 primary outcomes in all. 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 19 Nov 2020.