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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04635202
Other study ID # P.T.REC/012/002896
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 9, 2020
Est. completion date June 1, 2021

Study information

Verified date November 2020
Source Cairo University
Contact Ali Ismail, lecturer
Phone 02 01005154209
Email allooka2012@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 1, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria: - 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, . Exclusion criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
exercise training on elliptical device
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)
this group will receive general advises on maintaining physical activities for 16 weeks without any additional supervised training

Locations

Country Name City State
Egypt Faculty of Physical Therapy Cairo University Giza Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Triglycerides Triglycerides is one of lipid profile indicators It will be measured after 16 weeks of training
Primary high density lipoprotein high density lipoprotein is one of lipid profile indicators It will be measured after 16 weeks of training
Secondary Systolic blood pressure It will be measured via Sphygmomanometer It will be measured after 16 weeks of training
Secondary diastolic blood pressure It will be measured via Sphygmomanometer It will be measured after 16 weeks of training
Secondary Fasting blood glucose It will be measured via a blood glucose meter It will be measured after 16 weeks of training
Secondary Insulin it will be measured via a blood sample It will be measured after 16 weeks of training
Secondary The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance HOMA-IR = [fasting insulin (µU/mL)
× fasting glucose (mmol)]/22.5
It will be measured after 16 weeks of training
Secondary Waist circumference it will be measured by inelastic tape at the umbilicus level It will be measured after 16 weeks of training
Secondary weight the weight scale will be used It will be measured after 16 weeks of training
Secondary Leg strength test will be assessd by leg dynamometer It will be measured after 16 weeks of training
Secondary % body fat percentage of body fat composition It will be measured after 16 weeks of training
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