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Efficacy of ECE PEDO (Equipment for Clever Exercise) on Abdominal Obesity

Primary Purpose

Obesity, Abdominal, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supervised treadmill group (Group I)
ECE PEDO pedometer (Group II)
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Abdominal focused on measuring abdominal obesity, walking, aerobic exercise

Eligibility Criteria

26 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible participants who meet the criteria for inclusion were women with overweight weight or obesity and were 26-60 years old with a BMI (in kg/m2) from 27.1 to 39.6 and, waist circumference > 80 cm.

Exclusion Criteria:

  • The exclusion criteria were BMI values less than 24.9 and higher than 40, presence of a atherosclerotic heart disease, musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, and participation in a calorie restricted diets.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Supervised treadmill group

    ECE PEDO pedometer group

    Arm Description

    a. Supervised treadmill group (Group I): The participants were instructed walking exercise at their target heart rate on a treadmill in Sports Rehabilitation Unit of Pamukkale University.

    b. ECE PEDO® pedometer group (Group II): Participants were given the walking program with ECE PEDO giving audible feedback in case of any deviation from their target range of steps per minute.

    Outcomes

    Primary Outcome Measures

    Change from baseline in abdominal visceral fat thickness (VFT) at week 12.
    Ultrasonographic (US) imaging was performed by the convex probe with 3.5 Megahertz (General Electric Logic E9). Abdominal VFT measurement was done with the placement of probe transversely at 1 cm above of the umbilicus while the participant was lying in the supine position.
    Change from baseline in body mass index (BMI) at week 12.
    Weight and height were measured with weight scale and stadiometer. Body mass index (BMI) was calculated for as weight (kg) divided by height squared (m2).
    Change from baseline in waist circumference at week 12.
    Waist circumference was measured at the midpoint of the distance between the lowest rib and iliac crest with the non-elastic tape.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 27, 2017
    Last Updated
    April 5, 2017
    Sponsor
    Pamukkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03109340
    Brief Title
    Efficacy of ECE PEDO (Equipment for Clever Exercise) on Abdominal Obesity
    Official Title
    Efficacy of Moderate Intensity Walking Provided Feedback by ECE PEDO on Abdominal Fat in Women With Overweight and Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2013 (Actual)
    Primary Completion Date
    November 1, 2013 (Actual)
    Study Completion Date
    May 1, 2014 (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 the effectiveness of walking with ECE PEDO (Equipment for Clever Exercise) comparing supervised treadmill walking corresponding moderate aerobic exercise intensity on abdominal obesity and cardiorespiratory capacity.
    Detailed Description
    Objective: To show the effectiveness of walking with ECE PEDO (Equipment for Clever Exercise) comparing supervised treadmill walking corresponding moderate aerobic exercise intensity on abdominal obesity and cardiorespiratory capacity. Methods: Twenty-eight women with overweight and obesity were assigned to two groups: supervised treadmill walking (Group I,n=14) or walking with ECE PEDO (Group II,n=14). Target heart rate(HR) corresponding to values of 50-70% VO2max were determined by the submaximal treadmill test. Group 1 was 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 2 was instructed walking in these step range recorded to ECE PEDO giving audible feedback. Before and after a 12-week exercise program, participants were evaluated by BMI and waist circumference(WC); ultrasonographic visceral fat thickness(VFT) and ergospirometric VO2max.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Abdominal, Physical Activity
    Keywords
    abdominal obesity, walking, aerobic exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Women with overweight and obesity were assigned to two groups: supervised treadmill walking (Group I) or walking with ECE PEDO (Group II).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supervised treadmill group
    Arm Type
    Active Comparator
    Arm Description
    a. Supervised treadmill group (Group I): The participants were instructed walking exercise at their target heart rate on a treadmill in Sports Rehabilitation Unit of Pamukkale University.
    Arm Title
    ECE PEDO pedometer group
    Arm Type
    Experimental
    Arm Description
    b. ECE PEDO® pedometer group (Group II): Participants were given the walking program with ECE PEDO giving audible feedback in case of any deviation from their target range of steps per minute.
    Intervention Type
    Other
    Intervention Name(s)
    Supervised treadmill group (Group I)
    Intervention Description
    An exercise prescription was developed for each woman on the basis of the data acquired from the baseline treadmill exercise test. Target HR corresponding to values of 50-70% VO2max (moderate-intensity) was determined by the submaximal treadmill test.The participants were instructed walking exercise 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 II)
    Intervention Description
    Following a 10-minute rest after treadmill test, the participants were instructed to walk on the treadmill while maintaining their target heart rate. The number of steps taken in a minute was calculated using a criterion pedometer when target HR responses were reached. In this way, we determined the steps per minute required to moderate intensity walking for each participant. Detected individual step numbers were recorded to ECE PEDO for each person. Then participants were given the walking program with ECE PEDO giving audible feedback in case of any deviation from the range of steps per minute.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 visceral fat thickness (VFT) at week 12.
    Description
    Ultrasonographic (US) imaging was performed by the convex probe with 3.5 Megahertz (General Electric Logic E9). Abdominal VFT measurement was done with the placement of probe transversely at 1 cm above of the umbilicus while the participant was lying in the supine position.
    Time Frame
    Week 12.
    Title
    Change from baseline in body mass index (BMI) at week 12.
    Description
    Weight and height were measured with weight scale and stadiometer. Body mass index (BMI) was calculated for as weight (kg) divided by height squared (m2).
    Time Frame
    Week 12.
    Title
    Change from baseline in waist circumference at week 12.
    Description
    Waist circumference was measured at the midpoint of the distance between the lowest rib and iliac crest with the non-elastic tape.
    Time Frame
    Week 12.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    26 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Eligible participants who meet the criteria for inclusion were women with overweight weight or obesity and were 26-60 years old with a BMI (in kg/m2) from 27.1 to 39.6 and, waist circumference > 80 cm. Exclusion Criteria: The exclusion criteria were BMI values less than 24.9 and higher than 40, presence of a atherosclerotic heart disease, musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, and participation in a calorie restricted diets.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fusun Ardic, Prof.
    Organizational Affiliation
    University of Pamukkale
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Plan not defined as work is completed

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    Efficacy of ECE PEDO (Equipment for Clever Exercise) on Abdominal Obesity

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