Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome

• ClinicalTrials.gov Identifier: NCT04635202
• Recruitment Status: Recruiting
• First Posted: November 19, 2020
• Last Update Posted: November 19, 2020
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ali Mohamed Ali ismail, Cairo University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Behavioral: exercise training on elliptical device; Behavioral: group B (control group)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Elliptical Training on Lipids, Glucose and Insulin Homeostasis in Metabolic Syndrome
• Actual Study Start Date: September 9, 2020
• Estimated Primary Completion Date: May 15, 2021
• Estimated Study Completion Date: June 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: group A; 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	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; Other Name: group A
Group B (control group); patients (n=30) in this group will receive general advises on maintaining physical activities	Behavioral: group B (control group); this group will receive general advises on maintaining physical activities for 16 weeks without any additional supervised training

Outcome Measures

Primary Outcome Measures :

1. Triglycerides [ Time Frame: It will be measured after 16 weeks of training ]
   Triglycerides is one of lipid profile indicators
2. high density lipoprotein [ Time Frame: It will be measured after 16 weeks of training ]
   high density lipoprotein is one of lipid profile indicators

Secondary Outcome Measures :

1. Systolic blood pressure [ Time Frame: It will be measured after 16 weeks of training ]
   It will be measured via Sphygmomanometer
2. diastolic blood pressure [ Time Frame: It will be measured after 16 weeks of training ]
   It will be measured via Sphygmomanometer
3. Fasting blood glucose [ Time Frame: It will be measured after 16 weeks of training ]
   It will be measured via a blood glucose meter
4. Insulin [ Time Frame: It will be measured after 16 weeks of training ]
   it will be measured via a blood sample
5. The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance [ Time Frame: It will be measured after 16 weeks of training ]

   HOMA-IR = [fasting insulin (μU/mL)

   × fasting glucose (mmol)]/22.5

6. Waist circumference [ Time Frame: It will be measured after 16 weeks of training ]
   it will be measured by inelastic tape at the umbilicus level
7. weight [ Time Frame: It will be measured after 16 weeks of training ]
   the weight scale will be used
8. Leg strength test [ Time Frame: It will be measured after 16 weeks of training ]
   will be assessd by leg dynamometer
9. % body fat [ Time Frame: It will be measured after 16 weeks of training ]
   percentage of body fat composition

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: self-representation of gender identity.
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Ali Ismail, lecturer; 02 01005154209; allooka2012@gmail.com

Locations

Egypt

Faculty of Physical Therapy Cairo University; Recruiting

Giza, Dokki, Egypt

Contact: Ali Ismail, lecturer 02 01005154209 allooka2012@gmail.com

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Ali Ismail, lecturer; Cairo University

More Information

• Responsible Party: Ali Mohamed Ali ismail, lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo University
• ClinicalTrials.gov Identifier: NCT04635202
• Other Study ID Numbers: P.T.REC/012/002896
• First Posted: November 19, 2020
• Last Update Posted: November 19, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases