Obesity, AbdominalNCT03109340
Efficacy of ECE PEDO (Equipment for Clever Exercise) on Abdominal Obesity
A study testing Supervised treadmill group (Group I) and ECE PEDO pedometer (Group II) in people with Obesity, Abdominal and Physical Activity, run by Pamukkale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 60 years, women only
- Conditions the study is for
- Obesity, Abdominal, Physical Activity
- What is being tested?
- Supervised treadmill group (Group I) and ECE PEDO pedometer (Group II)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 1 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Efficacy of Moderate Intensity Walking Provided Feedback by ECE PEDO on Abdominal Fat in Women With Overweight and Obesity
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.
Read the 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.
- Conditions
- Obesity, Abdominal, Physical Activity
- Being tested
- Supervised treadmill group (Group I), ECE PEDO pedometer (Group II)
- Keywords
- abdominal obesity, walking, aerobic exercise
- Medical subject headings
- Obesity, Abdominal, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised treadmill group (Group I)Other
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.
ECE PEDO pedometer (Group II)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised treadmill group | Active comparator | 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. Receives: Other: Supervised treadmill group (Group I) |
| ECE PEDO pedometer group | Experimental | 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. Receives: Device: ECE PEDO pedometer (Group II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12.
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).
Measured: Week 12.
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.
Measured: Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 May 2013
- Primary completion1 Nov 2013
- Study completion1 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Füsun Ardıç, Pamukkale University
- Investigators
- Fusun Ardic, Prof., Study chair, University of Pamukkale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109340
- Sponsor's protocol ID
- 2013TPF009
- Status last verified
- Apr 2017
- First submitted
- 27 Mar 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan not defined as work is completed
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Moderate Intensity Walking Provided Feedback by ECE PEDO on Abdominal Fat in Women With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT03109340
- Acronym / sponsor ID
- 2013TPF009
- Conditions
- Obesity, Abdominal, Physical Activity
- Keywords
- abdominal obesity, walking, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 Nov 2013 (actual)
- Study completion
- 1 May 2014 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women with overweight and obesity were assigned to two groups: supervised treadmill walking (Group I) or walking with ECE PEDO (Group II).
| Arm | Type | Receives |
|---|---|---|
| Supervised treadmill group | Active comparator | Other: 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. |
| ECE PEDO pedometer group | Experimental | Device: 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. |
Who may qualify
- Ages
- 26 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised treadmill group (Group I)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. | Other | Supervised treadmill group |
| ECE PEDO pedometer (Group II)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. | Device | ECE PEDO pedometer group |
Primary outcome
Change from baseline in abdominal visceral fat thickness (VFT) at week 12.
Time frame: 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.
Time frame: 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.
Time frame: Week 12.
Waist circumference was measured at the midpoint of the distance between the lowest rib and iliac crest with the non-elastic tape.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: Undecided. Plan not defined as work is completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fusun Ardic, Prof. study chair
University of Pamukkale
Questions about this trial
What is this clinical trial studying?
A study testing Supervised treadmill group (Group I) and ECE PEDO pedometer (Group II) in people with Obesity, Abdominal and Physical Activity, run by Pamukkale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in abdominal visceral fat thickness (VFT) at week 12. (time frame: Week 12.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.