Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:27 AM
Study NCT ID:
NCT07447167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumbar Stabilization Exercises in Sedentary Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006804', 'term': 'Ergonomics'}], 'ancestors': [{'id': 'D004738', 'term': 'Engineering'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm parallel randomized controlled trial. Participants will be randomly assigned in a 1:1 ratio to either a lumbar stabilization exercise group or a control group receiving ergonomic and stretching instructions. Assessments will be conducted at baseline and post-intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Form-12 Health Survey (SF-12v2) Scores', 'timeFrame': 'Baseline and 4 weeks (post-intervention)', 'description': 'Health-related quality of life will be assessed using the SF-12v2 questionnaire. The eight domain scores (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health) as well as the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores will be calculated. Domain scores will be transformed to a 0-100 scale, with higher scores indicating better perceived health status. PCS and MCS will be computed using norm-based scoring (mean = 50, SD = 10), where higher values reflect better overall physical and mental health.'}], 'secondaryOutcomes': [{'measure': 'Y-Balance Test Composite Score', 'timeFrame': 'Baseline and 4 weeks (post-intervention)', 'description': 'Dynamic balance will be assessed using the Y-balance test. The composite approach distance for each lower limb will be calculated as:\n\n(ANT + PM + PL approach distance) / (3 × limb length) × 100. The composite score is expressed as a percentage of limb length. Minimum value: 0%. Maximum value: 100% (theoretically may exceed 100% in high-performing individuals). Higher values indicate better dynamic balance.\n\n\\[Time frame: Baseline and 4 weeks (after intervention)\\] Asymmetry will be calculated as the absolute difference between right and left normalized reach distances (% of limb length).\n\nMinimum value: 0%. No fixed maximum value. Higher values indicate greater asymmetry.'}, {'measure': 'Functional Movement Screen (FMS) Total Score', 'timeFrame': 'Baseline and 4 weeks (post-intervention)', 'description': 'Motor control will be assessed using the Functional Movement Screen (FMS). Higher scores indicate better motor control and movement quality. The total score ranges from 0 to 21 for the 7 functional test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prevention', 'back pain', 'lumbar spine stabilization exercises', 'sedentary behavior', 'sedentary work', 'lack of physical activity'], 'conditions': ['Sedentary Behavior', 'Motor Control Impairment', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'This pilot randomized controlled trial will examine the effects of a four-week lumbar spine stabilization exercise program on motor control, dynamic balance, and quality of life in healthy sedentary adults. Prolonged sedentary behavior has been associated with impaired neuromuscular function and increased risk of musculoskeletal disorders, even in asymptomatic individuals.\n\nForty sedentary adults will be randomly assigned to either an intervention group, which will follow a structured lumbar stabilization exercise program, or to a control group, which will receive ergonomic and stretching guidelines.\n\nOutcomes will be assessed before and after the intervention using the SF-12v2 quality of life questionnaire, the Functional Movement Screen (FMS) and the Y-Balance Test. Physical activity levels will be monitored using the IPAQ-SF. The study aims to determine whether lumbar stabilization exercises improve health-related quality of life, motor control and dynamic balance in sedentary adults.', 'detailedDescription': 'This study will employ a two-arm parallel randomized controlled design to examine the effectiveness of a four-week lumbar stabilization intervention in sedentary adults. Participants will be randomly allocated in a 1:1 ratio to either an exercise intervention group or a control group.\n\nTo enhance measurement reliability, two baseline assessments will be conducted prior to the intervention and two post-intervention assessments will be performed after completion of the program, with a three-day interval between repeated measurements.\n\nThe stabilization program will focus on activation and progressive strengthening of the deep trunk musculature, with particular emphasis on transversus abdominis and multifidus activation. Special attention will be given to the acquisition of diaphragmatic breathing patterns to facilitate neuromuscular control. Exercises will be performed in multiple positions, including supine, side-lying, prone, and quadruped positions. The level of difficulty will be progressively increased throughout the four-week intervention period.\n\nThe control group will receive written ergonomic education and general stretching instructions without supervised exercise.\n\nAssessments will be conducted using standardized and validated instruments to evaluate motor control, dynamic balance, and health-related quality of life. Statistical analysis will be performed using repeated-measures analysis of variance to assess within-group and between-group differences over time, with a predefined level of statistical significance set at 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults with a sedentary lifestyle (no regular structured exercise in the past 2-3 months)\n\n * Ability to participate in a moderate-intensity exercise program\n * Ability to understand instructions and complete assessment questionnaires\n\nExclusion Criteria:\n\n* Regular participation in structured exercise programs within the previous 2-3 months\n\n * Diagnosed lumbar disc herniation with neurological deficits\n * History of spinal or lower limb surgery within the past year\n * Acute musculoskeletal injury or exacerbation of low back pain within the past 4 weeks\n * Neurological or neuromuscular disorders\n * Active inflammatory rheumatic disease\n * Cardiopulmonary contraindications to moderate-intensity exercise\n * Pregnancy or postpartum period\n * Use of medications significantly affecting balance or physical performance\n * Inability to understand study instructions or comply with study procedures'}, 'identificationModule': {'nctId': 'NCT07447167', 'briefTitle': 'Lumbar Stabilization Exercises in Sedentary Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of West Attica'}, 'officialTitle': 'The Effect of a Lumbar Stabilization Exercise Program on Quality of Life and Motor Control in Sedentary Adults', 'orgStudyIdInfo': {'id': 'UWestAttica-LSE-116235'}, 'secondaryIdInfos': [{'id': '116235/12-11-2025', 'type': 'OTHER', 'domain': 'Ethics Committee, University of West Attica'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumbar Stabilization Exercise Group', 'description': 'Structured lumbar stabilization exercise program .', 'interventionNames': ['Behavioral: Lumbar Stabilization Exercise Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Ergonomic advice and general stretching exercise instructions.', 'interventionNames': ['Other: Ergonomic and Stretching Instructions']}], 'interventions': [{'name': 'Ergonomic and Stretching Instructions', 'type': 'OTHER', 'description': 'Educational booklet including ergonomic recommendations and general stretching exercises without supervised stabilization training.', 'armGroupLabels': ['Control Group']}, {'name': 'Lumbar Stabilization Exercise Program', 'type': 'BEHAVIORAL', 'description': 'A structured four-week lumbar stabilization exercise program targeting deep trunk musculature in healthy sedentary adults. The program will emphasize activation of the transversus abdominis, incorporation of diaphragmatic breathing, and progressive increase in exercise difficulty. Exercises will be performed under supervision in supine, prone, side-lying, and quadruped positions under structured guidance.', 'armGroupLabels': ['Lumbar Stabilization Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12243', 'city': 'Aigáleo', 'state': 'Attica', 'country': 'Greece', 'facility': 'University of West Attica', 'geoPoint': {'lat': 37.98333, 'lon': 23.68333}}], 'centralContacts': [{'name': 'Dimitra Korda, PT', 'role': 'CONTACT', 'email': 'dimitracorda@gmail.com', 'phone': '+306938441422'}, {'name': 'Georgios Koumantakis, PhD', 'role': 'CONTACT', 'email': 'gkoumantakis@uniwa.gr'}], 'overallOfficials': [{'name': 'Georgios Koumantakis, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of West Attica'}]}, 'ipdSharingStatementModule': {'url': 'https://research-ethics-comittee.uniwa.gr/kodikas-deontologias/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available upon reasonable request after publication of the study results, subject to institutional approval and data protection regulations.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data related to study outcomes and basic demographic characteristics will be made available upon reasonable request and subject to institutional approval.', 'accessCriteria': 'Data will be shared with qualified researchers upon reasonable request, following review and approval by the principal investigator and in accordance with applicable data protection regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of West Attica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc Student', 'investigatorFullName': 'Dimitra Korda', 'investigatorAffiliation': 'University of West Attica'}}}}