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
About this trial
This is an interventional treatment trial for Obesity, Abdominal focused on measuring abdominal obesity, walking, aerobic exercise
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.
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
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
Learn more about this trial
Efficacy of ECE PEDO (Equipment for Clever Exercise) on Abdominal Obesity
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