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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03445741
Other study ID # 2015TPF037
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date June 1, 2018

Study information

Verified date August 2018
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 1, 2018
Est. primary completion date April 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 65 Years
Eligibility 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 Design


Intervention

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.
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Outcome

Type Measure Description Time frame Safety issue
Primary *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
Primary *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
Primary *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
Primary *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
Primary *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
Primary *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
Primary *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
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