NCT06610955

Brief Summary

Obesity is one of the most common preventable public health problems. Diet regulation and exercise practices are the most commonly used methods in reducing fat tissue. There are various exercise methods applied in the weight loss process and the effects of different types of exercise modalities on body fat rate and metabolic status.The aim of our study is to determine the effects of high intensity interval exercise and moderate intensity continuous exercise on serum , omentin, leptin and adiponectin levels, anthropometric measurements used in obesity follow up, body fat percentage and their effects on the quality of sleep and life of women with obesity.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

September 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

October 18, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

September 15, 2024

Last Update Submit

February 3, 2025

Conditions

Keywords

ObesityExercise TrainingAdipokines

Outcome Measures

Primary Outcomes (1)

  • Serum adipokine levels

    This study aimed to investigate the effects of high intensity interval exercise and moderate intensity continuous exercise on serum adiponectin, leptin and omentin levels in young women with obesity.

    8 weeks

Secondary Outcomes (4)

  • Anthropometric measurement

    8 weeks

  • Percentage of body fat

    8 weeks

  • The impact of weight on quality of life

    8 weeks

  • Quality of sleep

    8 weeks

Study Arms (2)

High intensity interval training exercise group

ACTIVE COMPARATOR

After a 10 minutes warm up exercise, participants will exercise with a bicycle ergometry device at 80% of their maximum heart rate for 4 minutes, and the active recovery period will be 3 minutes (4x4 minutes). During the recovery period, the participant will exercise with the Ergoline bicycle ergometry system for 4 sets at 60% of their maximum heart rate for 3 minutes. A total of 45 minutes exercise session will be completed with a 10 minutes cool down exercise. Exercise will be done 5 days a week for a total of 8 weeks. In the first 4 weeks, exercise will be done at 80% intensity, and in the following weeks, the exercise intensity will be increased by 5% each week, respectively, to 85%, 90%, 95%, and 100% in the last week.

Other: High intensity interval training

Moderate intensity continuous exercise group

ACTIVE COMPARATOR

Following a 10 minutes warm up exercise, participants will exercise continuously for 30 minutes at 65% of their maximum heart rate with the Ergoline bicycle ergometry system. A 5 minutes cool down exercise will end the 45 minutes exercise session. The exercise duration is 5 days a week for a total of 8 weeks.

Other: Moderate intensity continuous training

Interventions

After a 10 minutes warm up exercise, participants will exercise with a bicycle ergometry device at 80% of their maximum heart rate for 4 minutes, and the active recovery period will be 3 minutes (4x4 minutes). During the recovery period, the participant will exercise with the Ergoline bicycle ergometry system for 4 sets at 60% of their maximum heart rate for 3 minutes. A total of 45 minutes exercise session will be completed with a 10 minutes cool down exercise. Exercise will be done 5 days a week for a total of 8 weeks. In the first 4 weeks, exercise will be done at 80% intensity, and in the following weeks, the exercise intensity will be increased by 5% each week, respectively, to 85%, 90%, 95%, and 100% in the last week.

High intensity interval training exercise group

Following a 10 minutes warm up exercise, participants will exercise continuously for 30 minutes at 65% of their maximum heart rate with the Ergoline bicycle ergometry system. A 5 minutes cool down exercise will end the 45 minutes exercise session. The exercise duration is 5 days a week for a total of 8 weeks.

Moderate intensity continuous exercise group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female between the age of 18-45
  • BMI 30-40 kg/m²
  • Primary obesity

You may not qualify if:

  • Patients with cardiac, pulmonary, endocrinological, rheumatological diseases
  • Pregnancy and breastfeeding
  • Using antipsychotics, antidepressants (lithium, tricyclic antidepressants, mono amino oxidase inhibitors), anticonvulsants, antihistamines, glucocorticoids, antidiabetics (sulfonylureas, insulins, glitazones) sex hormones
  • Using oral contraceptives
  • History of bariatric surgery
  • Patients using obesity medication in the last 6 months, complying with a regular diet and exercise program
  • Presence of orthopedic or neurological problems that difficulty of participate aerobic exercise training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran Üniversitesi

Kırşehir, 40100, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Figen Tuncay, Professor

    Ahi Evran Univeristy

    PRINCIPAL INVESTIGATOR
  • Elif Kapaklı, RA

    Kirsehir Ahi Evran Universitesi

    STUDY CHAIR
  • Gamze Turna Saltoğlu, Ass. Prof.

    Kirsehir Ahi Evran Universitesi

    STUDY CHAIR
  • Başak Çiğdem Karaçay, Assoc. Prof.

    Kirsehir Ahi Evran Universitesi

    STUDY CHAIR
  • Nazife Kapan, Ass. Prof.

    Kirsehir Ahi Evran Universitesi

    STUDY CHAIR
  • Başak Kavalcı Kol, Ass. Prof.

    Kirsehir Ahi Evran Universitesi

    STUDY CHAIR
  • Merve Fırat, Ass. Prof.

    Kirsehir Ahi Evran Universitesi

    STUDY CHAIR

Central Study Contacts

Figen Tuncay, Professor

CONTACT

Elif Kapaklı, RA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by a doctor who will be blinded to exercise group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups without control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2024

First Posted

September 24, 2024

Study Start

October 18, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations