Metabolic SyndromeNCT03445741
Efficacy of Various Aerobic Exercises on Abdominal Obesity in Women With Metabolic Syndrome.
A study testing Supervised treadmill group (%70 VO2 max) (group 1), Supervised treadmill group (%50 VO2 max) (group 2) and ECE PEDO pedometer group (%50 VO2 max) (group 3) in people with Metabolic Syndrome, run by Pamukkale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Supervised treadmill group (%70 VO2 max) (group 1), Supervised treadmill group (%50 VO2 max) (group 2) and ECE PEDO pedometer group (%50 VO2 max) (group 3)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 1 Jun 2018
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- 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)
- Keywords
- Aerobic exercise, Metabolic syndrome, Pedometer
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised treadmill group (%70 VO2 max) (group 1)Other
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.
Supervised treadmill group (%50 VO2 max) (group 2)Other
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.
ECE PEDO pedometer group (%50 VO2 max) (group 3)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised treadmill group (%70 VO2 max) | Active comparator | 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. Receives: Other: Supervised treadmill group (%70 VO2 max) (group 1) |
| Supervised treadmill group (%50 VO2 max) | Experimental | 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. Receives: Other: Supervised treadmill group (%50 VO2 max) (group 2) |
| ECE PEDO pedometer group (%50 VO2 max) | Experimental | 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. Receives: Device: ECE PEDO pedometer group (%50 VO2 max) (group 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
*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.
Measured: Week 12 and week 16
*Change from baseline in weight (kilograms) at week 12 and 4- week detraining period.
Weight was measured with weight scale.
Measured: Week 12 and week 16
*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.
Measured: Week 12 and week 16
*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.
Measured: Week 12 and week 16
*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.
Measured: Week 12 and week 16
*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.
Measured: Week 12 and week 16
*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.
Measured: Week 12 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Aug 2016
- Primary completion1 Apr 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Participants are assigned to three groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Füsun Ardıç, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445741
- Sponsor's protocol ID
- 2015TPF037
- Status last verified
- Aug 2018
- First submitted
- 11 Feb 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03445741
- Acronym / sponsor ID
- 2015TPF037
- Conditions
- Metabolic Syndrome
- Keywords
- Aerobic exercise, Metabolic syndrome, Pedometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 26 Feb 2018 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are assigned to three groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Supervised treadmill group (%70 VO2 max) | Active comparator | Other: Supervised treadmill group (%70 VO2 max) (group 1)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) | Experimental | Other: Supervised treadmill group (%50 VO2 max) (group 2)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) | Experimental | Device: ECE PEDO pedometer group (%50 VO2 max) (group 3)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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 (%70 VO2 max) (group 1)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. | Other | Supervised treadmill group (%70 VO2 max) |
| Supervised treadmill group (%50 VO2 max) (group 2)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. | Other | Supervised treadmill group (%50 VO2 max) |
| ECE PEDO pedometer group (%50 VO2 max) (group 3)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. | Device | ECE PEDO pedometer group (%50 VO2 max) |
Primary outcome
*Change from baseline in abdominal viseral fat and trunk fat and measured by VIScan at week 12 and 4-week detraining period.
Time frame: Week 12 and week 16
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.
Time frame: Week 12 and week 16
Weight was measured with weight scale.
*Change from baseline in Epinephrine/Adrenaline parameter at week 12 and 4- week detraining period.
Time frame: Week 12 and week 16
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.
Time frame: Week 12 and week 16
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.
Time frame: Week 12 and week 16
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.
Time frame: Week 12 and week 16
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.
Time frame: Week 12 and week 16
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.
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 29 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised treadmill group (%70 VO2 max) (group 1), Supervised treadmill group (%50 VO2 max) (group 2) and ECE PEDO pedometer group (%50 VO2 max) (group 3) in people with Metabolic Syndrome, 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 2 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 29 Aug 2018. 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 viseral fat and trunk fat and measured by VIScan at week 12 and 4-week detraining period. (time frame: Week 12 and week 16). The study lists 7 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 29 Aug 2018.