- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07372157
Neuromuscular Balance Exercise Effects in Overweight and Obese Individuals
Investigation of the Effectiveness of Neuromuscular Control-Based Exercises Combined With Aerobic and Strength Training Exercises on Balance in Overweight and Obese Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project will begin with initial assessments of volunteers to examine the effects of balance exercises on postural control and neuromuscular connections in obesity treatment. A multimodal exercise program (neuromuscular balance exercises, aerobic training, and resistance training) will be designed for individuals with obesity, and its effects on physical function, balance impairment, and weight management will be evaluated. In the first phase, participants' static and dynamic balance will be analyzed using clinical scales. In the second phase, an 8-week multimodal exercise program will be implemented, and the outcomes will be comparatively examined in relation to the weight loss process.
The study aims to provide scientific data to support the individualization of exercise programs by examining postural balance adaptations in response to changes in body composition during weight loss. The findings are expected to contribute to more comprehensive physical activity approaches in obesity management and to guide clinical applications.
This study adds a different perspective by evaluating the functional benefits of neuromuscular-based balance exercises in addition to traditional aerobic and strength training exercises. The assessment, conducted in individuals with obesity who have experienced weight loss, is expected to provide important findings for the interpretation and discussion of outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ekin UĞUR CANÖZ, MSc
- Phone Number: +905374525191
- Email: ekinugur@marun.edu.tr
Study Contact Backup
- Name: Mine Gülden G Polat, PhD
- Phone Number: 5710 +90216 777 57 00
- Email: gpolat@marmara.edu.tr
Study Locations
-
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34672
- Recruiting
- Fatih Sultan Mehmet Training and Research Hospital, Diabetes and Obesity Treatment Center
-
Contact:
- Özden Ezgi E Üner, MD
- Phone Number: +905323072789
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
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.
|
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.
|
|
Experimental: Intervention group
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Balance Performance (Four Step Square Test)
Time Frame: Baseline, at the 4th weeks and at the end of 8 weeks
|
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)
Time Frame: Baseline, Week 4, and Week 8
|
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)
Time Frame: Baseline, at the 4th weeks and at the end of 8 weeks
|
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)
Time Frame: Baseline, Week 4, and Week 8
|
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.
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Baseline, Week 4, and Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-Related Quality of Life Assessed by the Short Form-12 (SF-12)
Time Frame: Baseline, at the 4th weeks and at the end of 8 weeks
|
Health-related quality of life will be evaluated using the Short Form-12 (SF-12) Health Survey, which assesses physical and mental health components.
|
Baseline, at the 4th weeks and at the end of 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mine Gülden G Polat, PhD, Marmara University Faculty of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- 130.2024fbu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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