Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: exercise training on elliptical device; Behavioral: group B (control group)

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt
      • Recruiting
      • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: group A
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides	Triglycerides is one of lipid profile indicators	It will be measured after 16 weeks of training
high density lipoprotein	high density lipoprotein is one of lipid profile indicators	It will be measured after 16 weeks of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	It will be measured via Sphygmomanometer	It will be measured after 16 weeks of training
diastolic blood pressure	It will be measured via Sphygmomanometer	It will be measured after 16 weeks of training
Fasting blood glucose	It will be measured via a blood glucose meter	It will be measured after 16 weeks of training
Insulin	it will be measured via a blood sample	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	It will be measured after 16 weeks of training
Waist circumference	it will be measured by inelastic tape at the umbilicus level	It will be measured after 16 weeks of training
weight	the weight scale will be used	It will be measured after 16 weeks of training
Leg strength test	will be assessd by leg dynamometer	It will be measured after 16 weeks of training
% body fat	percentage of body fat composition	It will be measured after 16 weeks of training

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2020
• Primary Completion (ANTICIPATED): May 15, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (ACTUAL): November 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: P.T.REC/012/002896

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No