NCT07372157

Brief Summary

This randomized controlled study aims to evaluate the effects of adding neuromuscular balance exercises to exercise programs on functional capacity, balance, and physical fitness in individuals with obesity. Forty participants will be randomly assigned to either a control group receiving aerobic and strength training exercises or an intervention group receiving aerobic and strength training combined with neuromuscular balance exercises. Both exercise programs will be conducted three times per week for eight weeks. Functional capacity, balance, and physical fitness outcomes will be assessed at baseline and after the intervention period. The findings are expected to contribute to the integration of balance-focused exercises into rehabilitation programs for individuals with obesity.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jun 2025

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

Study Progress93%
Jun 2025Jun 2026

Study Start

First participant enrolled

June 15, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

January 28, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 18, 2025

Last Update Submit

January 20, 2026

Conditions

Keywords

ObesityExerciseNeuromuscular controlQuality of lifePostural stability

Outcome Measures

Primary Outcomes (4)

  • Dynamic Balance Performance (Four Step Square Test)

    Dynamic balance will be assessed using the Four Step Square Test, which measures the time (in seconds) required to complete a multidirectional stepping sequence.

    Baseline, at the 4th weeks and at the end of 8 weeks

  • Postural Control (Functional Reach Test)

    Postural control will be evaluated using the Functional Reach Test, which measures the maximal forward reach distance (in centimeters) while maintaining a fixed base of support.

    Baseline, Week 4, and Week 8

  • Walking Endurance (2-Minute Walk Test)

    Walking endurance will be assessed using the 2-Minute Walk Test, which measures the total distance walked in meters over a two-minute period.

    Baseline, at the 4th weeks and at the end of 8 weeks

  • Lower Extremity Functional Strength (30-Second Chair Stand Test)

    Lower extremity functional strength will be evaluated using the 30-Second Chair Stand Test, which measures the number of full stands completed within 30 seconds.

    Baseline, Week 4, and Week 8

Secondary Outcomes (1)

  • Health-Related Quality of Life Assessed by the Short Form-12 (SF-12)

    Baseline, at the 4th weeks and at the end of 8 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

Participants in the control group are individuals with obesity or overweight who receive a standardized exercise program that includes aerobic and strength training exercises. The program is performed three times per week over an eight-week period.

Behavioral: Aerobic and strength training

Intervention group

EXPERIMENTAL

Participants in the intervention group consist of individuals with obesity or overweight who receive the same aerobic and strength training program as the control group, with the addition of neuromuscular balance exercises. The intervention is performed three times per week for eight weeks.

Behavioral: Aerobic and strength trainingBehavioral: Neuromuscular balance exercises

Interventions

The aerobic and strength training program consists of supervised exercise sessions performed three days per week for eight weeks. Aerobic exercises are conducted at a moderate intensity, and strength training targets major muscle groups using body weight and resistance-based exercises. Each session is structured to include warm-up, main exercise components, and cool-down phases.

Control groupIntervention group

Neuromuscular balance exercises are added to the standard exercise program and are designed to improve postural control and balance. The exercises include progressive static and dynamic balance tasks and are performed three times per week for eight weeks under supervision.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in the study
  • Having a BMI of 25-35 kg/m2
  • Not having undergone any surgical operation in the last 6 months

You may not qualify if:

  • Any musculoskeletal disorder or systemic disease that would prevent exercise
  • Balance problems due to any disease that could prevent exercise
  • Psychiatric or neurological disease affecting cooperation and cognitive functions
  • Acute pain for any reason
  • Chest pain
  • History of myocardial infarction within the last year
  • Congestive heart failure
  • Patient's inability to adhere to treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital, Diabetes and Obesity Treatment Center

Istanbul, Istanbul, 34672, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

OverweightObesityMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mine Gülden G Polat, PhD

    Marmara University Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekin UĞUR CANÖZ, MSc

CONTACT

Mine Gülden G Polat, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study with no blinding of participants or investigators.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to either a control group or an intervention group, and both groups are followed in parallel throughout the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 28, 2026

Study Start

June 15, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 28, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations