Efficacy of Various Aerobic Exercises on Abdominal Obesity in Women With Metabolic Syndrome.

Effects of Different Intensities and Durations of Aerobic Exercise Training and Detraining on Metabolic, Hormonal Responses and Abdominal Obesity in Women With Metabolic Syndrome.

Objective: To show metabolic and hormonal responses and effects on abdominal obesity of aerobic exercise in different intensity and duration and detraining period in women with metabolic syndrome.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Supervised treadmill group (%70 VO2 max) (group 1); Other: Supervised treadmill group (%50 VO2 max) (group 2); Device: ECE PEDO pedometer group (%50 VO2 max) (group 3)

Detailed Description

Objective: To show metabolic and hormonal responses and effects on abdominal obesity of aerobic exercise in different intensity and duration and detraining period in women with metabolic syndrome.

Methods: Fifty-one women with metabolic syndrome were divided into three groups: 12 weekly sessions of high intensity supervised treadmill group, respectively, at % 70 of maximum oxygen consumption (group I, n=17), low intensity supervised treadmill group, respectively at % 50 of maximum oxygen consumption (group II, n=17) and walking at low intensity, respectively at % 50 of maximum oxygen consumption with ECEPEDO pedometer (group III, n=17). Target heart rate (HR) corresponding to values of 50-70 % VO2max were determined by the submaximal treadmill test. Group 1 and 2 were instructed walking at their target HR on a treadmill. The number of steps taken in a minute corresponding to target HR was determined by a criterion pedometer and group 3 was instructed walking in this step range recorded to ECE PEDO giving audible feedback. Participants were evaluated by weight, BMI, waist circumference (WC), blood sugar, LDL, HDL and triglyceride; viseral fat, trunk fat and waist circumference by bioelectrical impedance device (VIScan); ergospirometric VO2max at baseline, 12-week and 4-week detraining period.

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• eligible participants who meet the criteria for inclusion were women with metabolic syndrome diagnosis according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria and were 25-65 years old.
• Participants were well communicative, motivated and willing to participate in the study.

Exclusion Criteria:

• The exclusion criteria were presence of uncontrolled hypertension, type 2 diabetes mellitus, atherosclerotic heart disease, using drugs to affect thyroid, lipids metabolism and insulin sensitization, musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supervised treadmill group (%70 VO2 max); Supervised treadmill group (%70 VO2 max) (group 1): The participants were instructed walking exercise at their target heart rate, (% 70 of maximum oxygen consumption) on a treadmill in Sports Rehabilitation Unit of Pamukkale University.	Other: Supervised treadmill group (%70 VO2 max) (group 1); An exercise prescription was developed for each woman on the basis of the data acquired from the baseline treadmill exercise test. Target heart rate (HR) corresponding to values of 70% VO2max were determined by the submaximal treadmill test. The participants were instructed walking at their target HR on a treadmill in Sports Rehabilitation Unit of Pamukkale University. HR was monitored by a Polar HR monitor (Polar Beat, Port, Washington, NY). During 12 weeks, 3 days in a week and 20 minutes per day walking program was applied.
Experimental: Supervised treadmill group (%50 VO2 max); Supervised treadmill group (%50 VO2 max) (group 2): The participants were instructed walking exercise at their target heart rate, (% 50 of maximum oxygen consumption) on a treadmill in Sports Rehabilitation Unit of Pamukkale University.	Other: Supervised treadmill group (%50 VO2 max) (group 2); An exercise prescription was developed for each woman on the basis of the data acquired from the baseline treadmill exercise test. Target heart rate (HR) corresponding to values of 50% VO2max were determined by the submaximal treadmill test. The participants were instructed walking at their target HR on a treadmill in Sports Rehabilitation Unit of Pamukkale University. HR was monitored by a Polar HR monitor (Polar Beat, Port, Washington, NY). During 12 weeks, 5 days in a week and 30 minutes per day walking program was applied.
Experimental: ECE PEDO pedometer group (%50 VO2 max); ECE PEDO pedometer group (%50 VO2 max) (group 3): The participants were instructed walking with ECE PEDO which the number of steps taken in a minute corresponding to target HR at % 50 of maximum oxygen consumption were provided.	Device: ECE PEDO pedometer group (%50 VO2 max) (group 3); Target heart rate (HR) corresponding to values of 50 % VO2max were determined by the submaximal treadmill test. The number of steps taken in a minute corresponding to target HR was determined by a criterion pedometer and group 3 was instructed walking in this step range recorded to ECE PEDO giving audible feedback. During 12 weeks, 5 days in a week and 30 minutes per day walking program was applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
*Change from baseline in abdominal viseral fat and trunk fat and measured by VIScan at week 12 and 4-week detraining period.	BIA device ViScan, designed to estimate visceral adiposity and trunk fat percentage. A wireless 'electrode belt' is placed on the bare midriff of the subject in supine position. The belt then uses dual frequency bio impedance (6.25 and 50 kHz) to measure trunk and visceral fat resistance and transmit the readings via infrared to the base unit.	Week 12 and week 16
*Change from baseline in weight (kilograms) at week 12 and 4- week detraining period.	Weight was measured with weight scale.	Week 12 and week 16
*Change from baseline in Epinephrine/Adrenaline parameter at week 12 and 4- week detraining period.	Fasting blood samples were collected at morning hours before exercise testing. To perform adrenaline values, a sum of blood were stored at -80 C for later study.	Week 12 and week 16
*Change from baseline in noradrenaline parameter at week 12 and 4- week detraining period.	Fasting blood samples were collected at morning hours before exercise testing. To perform noradrenaline values, a sum of blood were stored at -80 C for later study.	Week 12 and week 16
*Change from baseline in free fatty acide parameter at week 12 and 4- week detraining period.	Fasting blood samples were collected at morning hours before exercise testing. To perform free fatty acide values, a sum of blood were stored at -80 C for later study.	Week 12 and week 16
*Change from baseline in oxyntomodulin parameter at week 12 and 4- week detraining period.	Fasting blood samples were collected at morning hours before exercise testing. To perform oxyntomodulin values, a sum of blood were stored at -80 C for later study.	Week 12 and week 16
*Change from baseline in glycerol parameter at week 12 and 4- week detraining period.	Fasting blood samples were collected at morning hours before exercise testing. To perform glycerol values, a sum of blood were stored at -80 C for later study.	Week 12 and week 16

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: February 11, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Aerobic exercise; Pedometer
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Insulin Resistance; Hyperinsulinism; Obesity; Syndrome; Metabolic Syndrome; Obesity, Abdominal
• Other Study ID Numbers: 2015TPF037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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