Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
exercise training on elliptical device
group B (control group)
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
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.
Sites / Locations
- Faculty of Physical Therapy Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
group A
Group B (control group)
Arm Description
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
patients (n=30) in this group will receive general advises on maintaining physical activities
Outcomes
Primary Outcome Measures
Triglycerides
Triglycerides is one of lipid profile indicators
high density lipoprotein
high density lipoprotein is one of lipid profile indicators
Secondary Outcome Measures
Systolic blood pressure
It will be measured via Sphygmomanometer
diastolic blood pressure
It will be measured via Sphygmomanometer
Fasting blood glucose
It will be measured via a blood glucose meter
Insulin
it will be measured via a blood sample
The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance
HOMA-IR = [fasting insulin (μU/mL)
× fasting glucose (mmol)]/22.5
Waist circumference
it will be measured by inelastic tape at the umbilicus level
weight
the weight scale will be used
Leg strength test
will be assessd by leg dynamometer
% body fat
percentage of body fat composition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04635202
Brief Title
Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome
Official Title
Effect of Elliptical Training on Lipids, Glucose and Insulin Homeostasis in Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
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
Arm Title
Group B (control group)
Arm Type
Other
Arm Description
patients (n=30) in this group will receive general advises on maintaining physical activities
Intervention Type
Behavioral
Intervention Name(s)
exercise training on elliptical device
Other Intervention Name(s)
group A
Intervention Description
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
Intervention Name(s)
group B (control group)
Intervention Description
this group will receive general advises on maintaining physical activities for 16 weeks without any additional supervised training
Primary Outcome Measure Information:
Title
Triglycerides
Description
Triglycerides is one of lipid profile indicators
Time Frame
It will be measured after 16 weeks of training
Title
high density lipoprotein
Description
high density lipoprotein is one of lipid profile indicators
Time Frame
It will be measured after 16 weeks of training
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
It will be measured via Sphygmomanometer
Time Frame
It will be measured after 16 weeks of training
Title
diastolic blood pressure
Description
It will be measured via Sphygmomanometer
Time Frame
It will be measured after 16 weeks of training
Title
Fasting blood glucose
Description
It will be measured via a blood glucose meter
Time Frame
It will be measured after 16 weeks of training
Title
Insulin
Description
it will be measured via a blood sample
Time Frame
It will be measured after 16 weeks of training
Title
The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance
Description
HOMA-IR = [fasting insulin (μU/mL)
× fasting glucose (mmol)]/22.5
Time Frame
It will be measured after 16 weeks of training
Title
Waist circumference
Description
it will be measured by inelastic tape at the umbilicus level
Time Frame
It will be measured after 16 weeks of training
Title
weight
Description
the weight scale will be used
Time Frame
It will be measured after 16 weeks of training
Title
Leg strength test
Description
will be assessd by leg dynamometer
Time Frame
It will be measured after 16 weeks of training
Title
% body fat
Description
percentage of body fat composition
Time Frame
It will be measured after 16 weeks of training
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity.
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
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Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome
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