Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 2:01 AM
Study NCT ID:
NCT06902961
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Game-Based Exercises on Balance, Kinesiophobia, Fatigue Levels, and Pain in Sedentary Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single Leg Stance Test', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Libra Swivel Balance Board', 'timeFrame': '6 weeks', 'description': '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'}, {'measure': 'International Physical Activity Questionnaire', 'timeFrame': '6 weeks', 'description': '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'}, {'measure': 'Tampa Kinesiophobia Scale', 'timeFrame': '6 weeks', 'description': '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'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'McGill Pain Questionnaire', 'timeFrame': '6 weeks', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'exercise'], 'conditions': ['Sedentary Behavior']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Technological advancements, such as electronic devices and machines that replace human labor, push individuals toward laziness, encouraging them to adopt a more inactive lifestyle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Accepting to participate in the study\n* Between the ages of 18 and 45\n* Physical activity level according to the International Physical Activity Questionnaire (short form) between 600 MET- 1500 MET min/week\n* 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\n* Physical activity level \\>1500 MET-min/week according to the International Physical Activity Questionnaire (short form)\n* Having cancer and malignant tumours\n* Presence of cognitive problems\n* Severe vision problems (colour blindness, blindness, etc.)'}, 'identificationModule': {'nctId': 'NCT06902961', 'briefTitle': 'The Effects of Game-Based Exercises on Balance, Kinesiophobia, Fatigue Levels, and Pain in Sedentary Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Effects of Game-Based Exercises on Balance, Kinesiophobia, Fatigue Levels, and Pain in Sedentary Individuals', 'orgStudyIdInfo': {'id': '2025-01/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Game-based exercise group', 'description': 'game-based', 'interventionNames': ['Other: Game-based exercise group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'control group', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'Game-based exercise group', 'type': 'OTHER', 'description': 'Game-based exercise group', 'armGroupLabels': ['Game-based exercise group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'control group', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bahceşehir University Health Center', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hazal genc', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}