NCT03445741

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

February 11, 2018

Last Update Submit

August 28, 2018

Conditions

Keywords

Aerobic exerciseMetabolic syndromePedometer

Outcome Measures

Primary Outcomes (7)

  • *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.

    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.

    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.

    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.

    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.

    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.

    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.

    Week 12 and week 16

Study Arms (3)

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.

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.

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.

Device: ECE PEDO pedometer group (%50 VO2 max) (group 3)

Interventions

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 (%70 VO2 max)

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.

Supervised treadmill group (%50 VO2 max)

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.

ECE PEDO pedometer group (%50 VO2 max)

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were well communicative, motivated and willing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to three groups in parallel for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor M.D.

Study Record Dates

First Submitted

February 11, 2018

First Posted

February 26, 2018

Study Start

August 1, 2016

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08