Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome

NCT04635202 | Unknown

• 1 other identifier: P.T.REC/012/002896
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Systolic blood pressure

  It will be measured after 16 weeks of training

• diastolic blood pressure

  It will be measured after 16 weeks of training

• Fasting blood glucose

  It will be measured after 16 weeks of training

• Insulin

  It will be measured after 16 weeks of training

• The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance

  It will be measured after 16 weeks of training

Study Arms (2)

group A

EXPERIMENTAL

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

Group B (control group)

OTHER

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

Behavioral: group B (control group)

Interventions

exercise training on elliptical device 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

Also known as: group A

group A

group B (control group) BEHAVIORAL

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

Group B (control group)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ali Ismail, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209; allooka2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: September 9, 2020
• Primary Completion: May 15, 2021
• Study Completion: June 1, 2021
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

EG (1)