Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Effect of Elliptical Training on Lipids, Glucose and Insulin Homeostasis in Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635202
• Other study ID #: P.T.REC/012/002896
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

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