Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04635202
Collaborator
(none)
60
1
2
8.7
6.9

Study Details

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
  • Behavioral: exercise training on elliptical device
  • Behavioral: group B (control group)
N/A

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
Anticipated 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 :
Sep 9, 2020
Anticipated Primary Completion Date :
May 15, 2021
Anticipated Study Completion Date :
Jun 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 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

    Outcome Measures

    Primary Outcome Measures

    1. Triglycerides [It will be measured after 16 weeks of training]

      Triglycerides is one of lipid profile indicators

    2. high density lipoprotein [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 [It will be measured after 16 weeks of training]

      It will be measured via Sphygmomanometer

    2. diastolic blood pressure [It will be measured after 16 weeks of training]

      It will be measured via Sphygmomanometer

    3. Fasting blood glucose [It will be measured after 16 weeks of training]

      It will be measured via a blood glucose meter

    4. Insulin [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 [It will be measured after 16 weeks of training]

      HOMA-IR = [fasting insulin (μU/mL) × fasting glucose (mmol)]/22.5

    6. Waist circumference [It will be measured after 16 weeks of training]

      it will be measured by inelastic tape at the umbilicus level

    7. weight [It will be measured after 16 weeks of training]

      the weight scale will be used

    8. Leg strength test [It will be measured after 16 weeks of training]

      will be assessd by leg dynamometer

    9. % body fat [It will be measured after 16 weeks of training]

      percentage of body fat composition

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Faculty of Physical Therapy Cairo University Giza Dokki Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ali Ismail, lecturer, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Nov 19, 2020
    Last Update Posted:
    Nov 19, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2020