Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT04910035
Status:
COMPLETED
Last Update Posted:
2024-09-03
First Post:
2021-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Square Stepping Exercises Training on Lower Extremity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single (Outcomes Assessor)'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Quality İndex', 'timeFrame': '3 weeks', 'description': 'Muscle quality was determined through Muscle Quality Index (MQI) which is a valid and reliable method developed by Takai et al. MQI measures 5 repetition sit-to-stand test duration (sec). MQI is calculated by measuring the 5-repetition sit-to-go test duration (sec), body weight (kg), and leg length (L-m). In the calculation, the formula "(L-0,5)\\*5\\*weight\\*g/5" repetitions sit-to-stand test duration is employed.'}, {'measure': 'Muscle Strength', 'timeFrame': '3 weeks', 'description': 'Hand-Held Dynamometer'}, {'measure': 'Motor Performance Assessment 1', 'timeFrame': '3 weeks', 'description': 'Vertical Jumping'}, {'measure': 'Motor Performance Assessment 2', 'timeFrame': '3 weeks', 'description': 'Step-Up'}, {'measure': 'Motor Performance Assessment 3', 'timeFrame': '3 weeks', 'description': 'One Leg Squat'}, {'measure': 'Motor Performance Assessment 4', 'timeFrame': '3 weeks', 'description': 'Side Jumping'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Square-stepping exercises', 'Healthy young individuals', 'Motor performance', 'Muscle strength', 'Muscle quality'], 'conditions': ['Sedentary Healthy Young Individuals']}, 'descriptionModule': {'briefSummary': 'Physical activity plays an indispensable role to lead a healthy life. Square-stepping exercises (SSE) are aerobic exercises.Our study was designed to investigate the effects of square-stepping exercise training on lower-extremity motor performance, muscle strength, and muscle quality of sedentary healthy young individuals.', 'detailedDescription': "A total of 120 volunteers within the age range of 20-25 participated in the research. Participants were randomly divided into two groups, as 60 participants were study group (35 females, 25 males) and 60 participants were control group (35 females, 25 males). Demographic data and exercise habit of the individuals were documented. Participants' lower-extremity motor performance was analyzed through Vertical Jumping, Side Jumping, One Leg Squat, and Step-Up tests. Participants' muscle strength was analyzed through Hand-Held Dynamometer. Also, participants' muscle quality was analyzed through Muscle Quality Index. Throughout 3 weeks SSE training was administered 4 days a week for a length of 45 minutes in each session. All the analyses were conducted at the start and at the end of 3-week long training"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-25 years old,\n* Not attending any exercise program for the last 1 year,\n* Not having a neurological, orthopedic disease or any disease affecting lower extremity,\n* Not having any lower-extremity surgery,\n* Individuals without vision and/or hearing problems were included in the study.\n\nExclusion Criteria:\n\n* Having a vision and/or hearing problem,\n* Having neurological, psychiatric, and/or orthopedic problems that affect walking,\n* Individuals with lower-extremity surgery were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04910035', 'briefTitle': 'The Effect of Square Stepping Exercises Training on Lower Extremity', 'organization': {'class': 'OTHER', 'fullName': 'Nigde Omer Halisdemir University'}, 'officialTitle': 'The Effect of Square Stepping Exercises Training on Lower Extremity Motor Performance, Muscle Strenght and Muscle Quality in Healthy Young People: a Single-Blind, Randomized, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '(11.06.2019-11)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Training Group', 'description': 'Throughout 3 weeks SSE training was administered 4 days a week for a length of 45 minutes in each session. All the analyses were conducted at the start and at the end of 3-week long training.', 'interventionNames': ['Other: Exercises Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'This group has no intervention. Evaluations were only made at the start and at the end of 3-week long.'}], 'interventions': [{'name': 'Exercises Training', 'type': 'OTHER', 'otherNames': ['Square-steeping exercise'], 'description': 'SSE is performed on a thin exercise mat divided into 40 small squares in 250 cm x 100 cm of size (25 cm each part). Participants are given patterns of a few steps and asked to take steps that match them. Participants must, in principal, move ahead in line with the length forward with no contact on the lines forming the squares. Forward, backward, lateral and oblique stepping patterns are required. Stepping patterns get increasingly difficult. Each pattern consists of 2 to 16 steps; participants are asked to repeat step pattern till the end of exercise mat. Upon completing a pattern, another pattern in the same mirror-image is repeated. In essence each pattern is reiterated for 3-5 times and next its mirror-image pattern is repeated but if participants face challenge in performing the pattern it is repeated till the pattern is learnt', 'armGroupLabels': ['Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51200', 'city': 'Niğde', 'state': 'Bor', 'country': 'Turkey (Türkiye)', 'facility': 'Nigde Omer Halisdemir University', 'geoPoint': {'lat': 37.96583, 'lon': 34.67935}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nigde Omer Halisdemir University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pamukkale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Asli Demirtaş', 'investigatorAffiliation': 'Nigde Omer Halisdemir University'}}}}