- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06902961
The Effects of Game-Based Exercises on Balance, Kinesiophobia, Fatigue Levels, and Pain in Sedentary Individuals
August 11, 2025 updated by: hazal genc, Istanbul Medipol University Hospital
Physical activity is a significant factor that greatly affects human health.
However, with the development of technology, there has been a significant decrease in the physical activity levels of individuals in their daily lives, leading to the emergence of a sedentary society.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Technological advancements, such as electronic devices and machines that replace human labor, push individuals toward laziness, encouraging them to adopt a more inactive lifestyle.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34070
- Bahceşehir University Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- Accepting to participate in the study
- Between the ages of 18 and 45
- Physical activity level according to the International Physical Activity Questionnaire (short form) between 600 MET- 1500 MET min/week
- Having an appropriate cognitive level (not having a cognitive level that would make it difficult to understand the study or to perform the exercise) Exclusion Criteria
- Physical activity level >1500 MET-min/week according to the International Physical Activity Questionnaire (short form)
- Having cancer and malignant tumours
- Presence of cognitive problems
- Severe vision problems (colour blindness, blindness, etc.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Game-based exercise group
game-based
|
Game-based exercise group
|
|
Active Comparator: control group
|
control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single Leg Stance Test
Time Frame: 6 weeks
|
A method used to assess static balance.
Participants are asked to stand on one leg with eyes open and arms crossed at chest level.
The raised leg should not touch or make contact with the ground.
The individual must maintain their position without any jerking, jumping, or touching any nearby objects for support.
The time they can maintain the position is recorded in seconds.
|
6 weeks
|
|
Libra Swivel Balance Board
Time Frame: 6 weeks
|
A computer-based device used to assess dynamic balance.
The Libra swivel balance board (42 cm long and 42 cm wide) is equipped with a computer system.
Dynamic balance is measured using specific software
|
6 weeks
|
|
Fatigue Severity Scale
Time Frame: 6 weeks
|
This scale measures the severity of fatigue over the last week, with 9 questions scored on a 7-point scale.
Higher scores (28 or above) indicate severe fatigue.
|
6 weeks
|
|
McGill Pain Questionnaire
Time Frame: 6 weeks
|
Developed by Melzack, this scale assesses pain sensory aspects using 15 descriptive words.
Participants rate their pain intensity on a scale from 0 (none) to 3 (severe)
|
6 weeks
|
|
International Physical Activity Questionnaire
Time Frame: 6 weeks
|
this questionnaire provides information on the time spent on sitting, walking, moderate-intensity, and vigorous-intensity activities.
The Turkish validity and reliability study was conducted by Öztürk (2005).
It classifies individuals as sedentary, minimally active, or highly active based on MET-minute/week score
|
6 weeks
|
|
Tampa Kinesiophobia Scale
Time Frame: 6 weeks
|
It evaluates fear of movement and injury.
The scale consists of 17 items with 4 response options (1 = Strongly Disagree to 4 = Strongly Agree).
Higher scores indicate greater kinesiophobia
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2025
Primary Completion (Actual)
March 15, 2025
Study Completion (Actual)
June 25, 2025
Study Registration Dates
First Submitted
March 24, 2025
First Submitted That Met QC Criteria
March 28, 2025
First Posted (Actual)
March 30, 2025
Study Record Updates
Last Update Posted (Actual)
August 12, 2025
Last Update Submitted That Met QC Criteria
August 11, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-01/06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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