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

Not Applicable

Completed

• Conditions: Obesity, Abdominal; Physical Activity
• Interventions: Device: ECE PEDO pedometer (Group II); Other: Supervised treadmill group (Group I)

• Registration Number: NCT03109340
• Lead Sponsor: Pamukkale University

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.

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2013-11-01
• Study Completion: 2014-05-01
• Study First Submitted: 2017-03-27
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-05
• Last Update Submitted: 2017-04-05
• Study First Posted: 2017-04-12
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECE PEDO pedometer group	ECE PEDO pedometer (Group II)	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.
Supervised treadmill group	Supervised treadmill group (Group I)	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in body mass index (BMI) at week 12.	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 abdominal visceral fat thickness (VFT) at week 12.	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 waist circumference at week 12.	Week 12.	Waist circumference was measured at the midpoint of the distance between the lowest rib and iliac crest with the non-elastic tape.