NCT06584578

Brief Summary

Effect of 12 Weeks of Different Exercise Training Modalities and Nutritional Guidance on Body Composition The purpose of the study was to examine the effect of 12 weeks of different exercise training modalities and nutritional guidance on body composition.This study was conducted voluntarily by individuals who applied to a private health center in the Safranbolu district of Karabük and received medical nutrition treatment. It was conducted on four groups as Pilates, Yoga, WB-EMS and control and lasted 12 weeks in total. The training period of the participants in the group other than the control group was 2 days a week and 45 minutes per day, and 3 exercises consisted of warm-up, main part and cool-down parts. Some body composition assessments were made to the participants before and after their 12-week exercises. Body composition measurements (height, body weight, body mass index, body fat and muscle percentage) and systolic and diastolic blood pressure measurements were taken. Maximum heart rate (HRmax) (beats/min), average HR (beats/min), total calories burned (kcal) were determined to determine and monitor the load and intensity of each exercise for 12 weeks, and the Borg Scale was applied to the participants after each exercise to determine the degree of difficulty they perceived from the exercise they did and to evaluate their enjoyment of the exercises. Also, A personalized nutrition program prepared by a specialist dietitian for 12 weeks.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 15, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

September 2, 2024

Last Update Submit

September 2, 2024

Conditions

Keywords

ExerciseWB-EMSPilatesYogaNutritional GuidanceBody Composition

Outcome Measures

Primary Outcomes (1)

  • Muscle mass changes from baseline assessment to 12 week follow-up assessment

    Muscle mass changes from baseline assessment to 12 week follow-up assessment as determined my Bio Impedance Analysis

    From baseline assessment to 12 week follow-up assessment

Secondary Outcomes (4)

  • Body Fat Content changes from baseline assessment to 12 week follow-up

    From baseline assessment to 12 week follow-up assessment

  • Body Fat Mass changes from baseline assessment to 12 week follow-up assessment

    From baseline assessment to 12 week follow up assessment

  • Body mass changes from baseline assessment to 12 week follow-up assessment

    From baseline assessment to 12 week follow-up assessment

  • Body water changes from baseline assessment to 12 week follow-up assessment

    From baseline assessment to 12 week follow-up assessment

Study Arms (4)

Whole-Body Electomyostimulation (WB-EMS)

EXPERIMENTAL

Whole-Body Electromyostimulation

Other: Whole-Body Electromyostimulation

Pilates

EXPERIMENTAL

Pilates

Other: Pilates

Tai Chi

EXPERIMENTAL

Tai-Chi exercise

Other: Tai Chi

Nutrition counseling

ACTIVE COMPARATOR

Nutrition counseling for 12 weeks

Other: Nutritional counseling

Interventions

Participants were included in tree exercise programs (Yoga, Pilates, WB-EMS) by an expert trainer 2 days a week for 12 weeks. At the same time, an active control group conducted a weekly diet counseling for 12 weeks by an expert dietician.

Also known as: Whole-Body Electromyostimulation exercise, Pilates exercise, Tai Chi exercise
Whole-Body Electomyostimulation (WB-EMS)
PilatesOTHER

Pilates exercise twice weekly for 12 weeks

Pilates
Tai ChiOTHER

Pilates exercise twice weekly for 12 weeks

Tai Chi

Nutritional counseling for 12 weeks

Nutrition counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being healthy
  • Willing to maintain the intervention for 12 weeks

You may not qualify if:

  • Being under 18 years old
  • Having a chronic disease
  • Medication that relevantly affect muscle metabolism
  • Contraindication for Bio Impedance Analysis
  • Contraindication for Whole Body Electromyostimulation
  • Contraindications for exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Centre, 78200, Turkey (Türkiye)

Location

Related Publications (2)

  • Willert S, Weissenfels A, Kohl M, von Stengel S, Frohlich M, Kleinoder H, Schone D, Teschler M, Kemmler W. Effects of Whole-Body Electromyostimulation on the Energy-Restriction-Induced Reduction of Muscle Mass During Intended Weight Loss. Front Physiol. 2019 Aug 12;10:1012. doi: 10.3389/fphys.2019.01012. eCollection 2019.

    PMID: 31456693BACKGROUND
  • Kemmler W, Weissenfels A, Teschler M, Willert S, Bebenek M, Shojaa M, Kohl M, Freiberger E, Sieber C, von Stengel S. Whole-body electromyostimulation and protein supplementation favorably affect sarcopenic obesity in community-dwelling older men at risk: the randomized controlled FranSO study. Clin Interv Aging. 2017 Sep 21;12:1503-1513. doi: 10.2147/CIA.S137987. eCollection 2017.

    PMID: 28989278BACKGROUND

MeSH Terms

Conditions

ObesityOverweightWeight LossMotor Activity

Interventions

Exercise Movement TechniquesAquatic TherapyTai JiNutrition Assessment

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsHydrotherapyRehabilitationMind-Body TherapiesComplementary TherapiesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Neslihan AKÇAY, Doctorate

    Karabuk University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants were strictly separated and think their intervention is the main intervention. The same is true for care providers. Outcome assessors were unaware of participant group status and were not allowed to ask correspondingly
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 5, 2024

Study Start

June 15, 2023

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

September 5, 2024

Record last verified: 2024-09

Locations