NCT03409172

Brief Summary

The main purpose of this study is to compare the effects of high intensity interval training and moderate intensity continuous training on inflammatory profile and metabolic markers, after 8 weeks of intervention trial in obese women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

January 9, 2018

Last Update Submit

January 23, 2018

Conditions

Obesity and Metabolic Syndrome

Keywords

High intensity interval trainingInflammationObesityadipokines

Outcome Measures

Primary Outcomes (3)

  • Inflammatory profile

    C-reactive protein (CRP) (mg/dL)

    8 weeks (baseline to 8 week follow-up assessment)

  • Inflammatory profile

    Interleukin 6 (IL-6) (ng/mL)

    8 weeks (baseline to 8 week follow-up assessment)

  • Inflammatory profile

    Interleukin 10 (IL-10) pg/mL, Interleukin-1B (IL-1B) pg/mL, Tumor Necrosis Factor (TNF)-α (pg/mL), Adiponectin (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL), Leptin (pg/mL)

    8 weeks (baseline to 8 week follow-up assessment)

Secondary Outcomes (10)

  • Body Composition and Anthropometric profile

    8 weeks (baseline to 8 week follow-up assessment) ]

  • Body Composition and Anthropometric profile

    8 weeks (baseline to 8 week follow-up assessment) ]

  • Body Composition and Anthropometric profile

    8 weeks (baseline to 8 week follow-up assessment) ]

  • Body Composition and Anthropometric profile

    8 weeks (baseline to 8 week follow-up assessment) ]

  • Insulin sensitivity

    8 weeks (baseline to 8 week follow-up assessment) ]

  • +5 more secondary outcomes

Study Arms (3)

Control group (CTr)

EXPERIMENTAL

No counseling or nutritional therapy and no exercise

Other: CTR

Moderate intensity continuous training (MICT)

EXPERIMENTAL

Follow-up during a period of 8 weeks of supervised ergometer-based moderate-intensity continuous training based on HRmax (MICT). MICT: * 3 sessions per week * intensity at 65-75% HRmax * time-effort per session: 50 min

Other: MICT

High Intensity Interval Training (HIIT)

EXPERIMENTAL

Procedures: Follow-up during a period of 8 weeks of supervised ergometer-based high intensity interval training based on HRmax (HIIT). HIIT: * 3 sessions per week * 10 bouts of one minute at 90% HRmax interspersed by one minute at 40% HRmax * time-effort per session: 25 min

Other: HIIT

Interventions

CTROTHER

no counseling or nutritional therapy and no exercise

Control group (CTr)
MICTOTHER

no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).

Moderate intensity continuous training (MICT)
HIITOTHER

no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT)

High Intensity Interval Training (HIIT)

Eligibility Criteria

Age25 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index between (30-40 kg/m²)
  • age between 25 and 41 years
  • to be sedentary

You may not qualify if:

  • type 1 or type 2 diabetes
  • Hypertension
  • pregnancy, Lactation
  • having undergone bariatric surgery
  • psychological disorders, epilepsy, sever neurological disorders
  • participation in other moderate, vigorous exercise or nutrition intervention
  • acute or chronic cardiovascular disease
  • malignant disease
  • kidney disease
  • lung disease
  • hyperthyroidism or hypothyroidism
  • smoking any type of cigarette
  • joint limitations
  • electronic implants (defibrillator, pacemaker)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityMetabolic SyndromeInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesPathologic Processes

Study Officials

  • Vivian M M SUEN, PhD

    fmrp usp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three-arm parallel, Randomized-controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 24, 2018

Study Start

June 1, 2016

Primary Completion

January 8, 2018

Study Completion

January 8, 2018

Last Updated

January 24, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share