Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome

NCT ID: NCT04635202

Last Updated: 2020-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2021-06-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

exercise training on elliptical device

Intervention Type: BEHAVIORAL

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)

patients (n=30) in this group will receive general advises on maintaining physical activities

Group Type: OTHER

group B (control group)

Intervention Type: BEHAVIORAL

this group will receive general advises on maintaining physical activities for 16 weeks without any additional supervised training

Interventions

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

Intervention Type: BEHAVIORAL

group B (control group)

this group will receive general advises on maintaining physical activities for 16 weeks without any additional supervised training

Intervention Type: BEHAVIORAL

Other Intervention Names

group A

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ali Ismail, lecturer

Role: CONTACT

Phone: 02 01005154209

Email: allooka2012@gmail.com

Facility Contacts

Ali Ismail, lecturer

Role: primary

Other Identifiers

P.T.REC/012/002896

Identifier Type: -

Identifier Source: org_study_id