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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supervised treadmill group (%70 VO2 max) (group 1)
Supervised treadmill group (%50 VO2 max) (group 2)
ECE PEDO pedometer group (%50 VO2 max) (group 3)
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Aerobic exercise, Metabolic syndrome, Pedometer

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Supervised treadmill group (%70 VO2 max)

    Supervised treadmill group (%50 VO2 max)

    ECE PEDO pedometer group (%50 VO2 max)

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    *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.
    *Change from baseline in weight (kilograms) at week 12 and 4- week detraining period.
    Weight was measured with weight scale.
    *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.
    *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.
    *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.
    *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.
    *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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 11, 2018
    Last Updated
    August 28, 2018
    Sponsor
    Pamukkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03445741
    Brief Title
    Efficacy of Various Aerobic Exercises on Abdominal Obesity in Women With Metabolic Syndrome.
    Official Title
    Effects of Different Intensities and Durations of Aerobic Exercise Training and Detraining on Metabolic, Hormonal Responses and Abdominal Obesity in Women With Metabolic Syndrome.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    April 1, 2018 (Actual)
    Study Completion Date
    June 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pamukkale University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    Aerobic exercise, Metabolic syndrome, Pedometer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants are assigned to three groups in parallel for the duration of the study.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Supervised treadmill group (%70 VO2 max)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Supervised treadmill group (%50 VO2 max)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    ECE PEDO pedometer group (%50 VO2 max)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Supervised treadmill group (%70 VO2 max) (group 1)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Supervised treadmill group (%50 VO2 max) (group 2)
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    ECE PEDO pedometer group (%50 VO2 max) (group 3)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    *Change from baseline in abdominal viseral fat and trunk fat and measured by VIScan at week 12 and 4-week detraining period.
    Description
    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.
    Time Frame
    Week 12 and week 16
    Title
    *Change from baseline in weight (kilograms) at week 12 and 4- week detraining period.
    Description
    Weight was measured with weight scale.
    Time Frame
    Week 12 and week 16
    Title
    *Change from baseline in Epinephrine/Adrenaline parameter at week 12 and 4- week detraining period.
    Description
    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.
    Time Frame
    Week 12 and week 16
    Title
    *Change from baseline in noradrenaline parameter at week 12 and 4- week detraining period.
    Description
    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.
    Time Frame
    Week 12 and week 16
    Title
    *Change from baseline in free fatty acide parameter at week 12 and 4- week detraining period.
    Description
    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.
    Time Frame
    Week 12 and week 16
    Title
    *Change from baseline in oxyntomodulin parameter at week 12 and 4- week detraining period.
    Description
    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.
    Time Frame
    Week 12 and week 16
    Title
    *Change from baseline in glycerol parameter at week 12 and 4- week detraining period.
    Description
    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.
    Time Frame
    Week 12 and week 16

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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