Clinical trial NCT04635202: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Triglycerides
timeFrame: It will be measured after 16 weeks of training
measure: high density lipoprotein
timeFrame: It will be measured after 16 weeks of training
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: It will be measured after 16 weeks of training
measure: diastolic blood pressure
timeFrame: It will be measured after 16 weeks of training
measure: Fasting blood glucose
timeFrame: It will be measured after 16 weeks of training
measure: Insulin
timeFrame: It will be measured after 16 weeks of training
measure: The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance
timeFrame: It will be measured after 16 weeks of training
measure: Waist circumference
timeFrame: It will be measured after 16 weeks of training
measure: weight
timeFrame: It will be measured after 16 weeks of training
measure: Leg strength test
timeFrame: It will be measured after 16 weeks of training
measure: % body fat
timeFrame: It will be measured after 16 weeks of training
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: