Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT04209335
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2019-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Isometric Core Muscle Endurance in Healthy Active and Non-active Working Age Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'H.Holmberg@edu.salford.ac.uk', 'phone': '07488550768', 'title': 'ISOMETRIC CORE MUSCLE ENDURANCE IN HEALTHY ACTIVE AND NON-ACTIVE WORKING AGE POPULATIONS', 'organization': 'University of Salford'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data was collected on a nonspecific time of the day, in 1 hour', 'description': "All possible health risks were excluded in recruitment phase as it was considered as exclusion criteria. Also, each participant was allowed to stop at any time during the testing. All possible other events were recorded from participants' feedback during and right after testing.", 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Working Age Population', 'description': 'the sum of 4 isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank on each side)\n\nisometric core muscle endurance testing: holding previously described isometric positions until fatigue', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 12, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Shoulder, elbow, lower back pain', 'notes': 'Pain during testing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'pain'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Core Muscle Endurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Working Age Population', 'description': 'the sum of 4 isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank on each side)\n\nisometric core muscle endurance testing: holding previously described isometric positions until fatigue'}], 'classes': [{'categories': [{'measurements': [{'value': '530.5', 'spread': '34.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at the time of testing, in 1 hour', 'description': 'time in seconds after summing the results of all 4 tests', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Working Age Population', 'description': 'the body mass index of the participant, at the time of testing'}], 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '31.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the time of testing, in 1 h', 'description': 'weight(kg)/height(cm)2 Value under 18.5 is considered underweight, over 25 overweight, and over 30 obese.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Activity Level Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Working Age Population', 'description': 'Number of active participants who met national and international guidelines'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the time of testing, last 2 weeks', 'description': 'physical activity level based on national and international recommendations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Have Experienced Non-specific Lower Back Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Working Age Population', 'description': 'Number of participants who have experienced nonspecific low back pain'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 months before the assessment', 'description': 'categorical data, experience of nonspecific low back pain up to 6 months before the assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Working Age Population', 'description': 'isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank)\n\nisometric core muscle endurance testing: holding previously described isometric positions until fatigue'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the general population with different lifestyles and jobs.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Working Age Population', 'description': 'isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank)\n\nisometric core muscle endurance testing: holding previously described isometric positions until fatigue'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were viewed separately as well as in two groups- participants up to 40 years and participants over 40 years.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '66'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'BG000', 'lowerLimit': '15.9', 'upperLimit': '31.6'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of participants considered active', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Based on national and international guidelines. It is suggested that adults aged between 18 and 65 should do moderate-intensity aerobic physical activities for a minimum of 30 minutes, 5 times a week, or high-intensity aerobic activities 20 minutes, 3 times a week. Participants who met the above guideline were considered as active.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants who have experienced non-specific lower back pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were asked if they have experienced non-specific lower back pain in last 6 months.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-28', 'size': 116233, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-23T11:50', 'hasProtocol': True}, {'date': '2018-05-28', 'size': 169450, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-23T11:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-07', 'studyFirstSubmitDate': '2019-12-16', 'resultsFirstSubmitDate': '2020-01-28', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-07', 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core Muscle Endurance', 'timeFrame': 'at the time of testing, in 1 hour', 'description': 'time in seconds after summing the results of all 4 tests'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'during the time of testing, in 1 h', 'description': 'weight(kg)/height(cm)2 Value under 18.5 is considered underweight, over 25 overweight, and over 30 obese.'}, {'measure': 'Physical Activity Level Questionnaire', 'timeFrame': 'at the time of testing, last 2 weeks', 'description': 'physical activity level based on national and international recommendations'}, {'measure': 'Number of Participants Who Have Experienced Non-specific Lower Back Pain', 'timeFrame': 'up to 6 months before the assessment', 'description': 'categorical data, experience of nonspecific low back pain up to 6 months before the assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aging', 'lower back pain', 'physical activity level', 'body mass index', 'core muscle endurance', 'gender', 'McGill V-sit', 'Biering-Sorensen', 'sideplank'], 'conditions': ['Physical Endurance']}, 'descriptionModule': {'briefSummary': "Objectives: The purpose of this study was to investigate a possible correlation between core muscle endurance and participants' age in healthy adult population. Secondary purpose was to identify other dependent variables influencing isometric core muscle endurance (e.g. low back pain, physical activity, gender, body mass index).\n\nMethods: 48 (35 females, 13 males) healthy adults (aged 21-66 years) performed 4 isometric core muscle endurance tests- Biering-Sorensen, McGill V-sit, right and left side plank. A correlation between core endurance and age, gender, lower back pain (LBP), physical activity level (PAL), and body mass index (BMI) was calculated.", 'detailedDescription': "This is the first study to investigate the core muscle endurance of different age groups and genders with all four endurance tests of the core.\n\nSince strength and endurance are key to keeping healthy as we age and National Institute for Health and Care Excellence (NICE) and European guidelines advocate them, this study aims to look at the 3 main measurements of core endurance namely flexor, extensor and lateral muscles, and the possible correlations with age, PAL, existence of LBP, BMI and gender. Each participant performed 4 isometric core endurance tests in the same order- 1. Biering-Sorensen, 2.-3. side plank on both sides, and 4. McGill V-sit. All participants were tested by the same tester to reduce potential differences in procedure and testing error. The four tests were each measured using a stopwatch and documented in seconds. Each participant was told the time they had reached during testing to improve their motivation. Pain during testing was documented.\n\nBased on the normative data of abdominal muscle endurance for young adults Null hypothesis (H0)- There is no significant difference in endurance tests for age, presence of LBP or PAL. Hypothesis (H1)- Any significant difference in endurance tests for age, presence of LBP or PAL are due to chance factors. This is a two-tailed hypothesis, as previous evidence shows conflicting results. Pearson's correlation and Independent T-test in SPSS (The Statistical Package for the Social Sciences) were used to confirm or reject the possible correlations between the core muscle endurance and age, LBP, PAL, gender, BMI, and participants' job."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 20-70 (working age population)\n* healthy\n* active and non-active\n* with or without non-specific lower back pain\n\nExclusion Criteria:\n\n* all serious pathologies and diagnosis that could affect the ability to perform the tests safely including acute pain, neurological, musculoskeletal, cardiovascular diseases, spinal pathologies (e.g. spondylitis, acute herniated disc, cauda equina, hypertension, epilepsy, tumour, previous fracture or surgery in trunk, structured deformity, osteoporosis)\n* sudden change in health\n* personal reasons\n* severe pain during testing\n* competing in any sports higher than amateur level'}, 'identificationModule': {'nctId': 'NCT04209335', 'briefTitle': 'Isometric Core Muscle Endurance in Healthy Active and Non-active Working Age Populations', 'organization': {'class': 'OTHER', 'fullName': 'University of Salford'}, 'officialTitle': 'Isometric Core Muscle Endurance in Healthy Active and Non-active Working Age Populations', 'orgStudyIdInfo': {'id': 'HST 1718-316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'healthy working age population', 'description': 'isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank)', 'interventionNames': ['Other: isometric core muscle endurance testing']}], 'interventions': [{'name': 'isometric core muscle endurance testing', 'type': 'OTHER', 'description': 'holding previously described isometric positions until fatigue', 'armGroupLabels': ['healthy working age population']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6 6PU', 'city': 'Manchester', 'state': 'Salford', 'country': 'United Kingdom', 'facility': 'University of Salford', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Lynne E Gaskell, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Supervisor'}, {'name': 'Hanna Holmberg, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'student'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanna Holmberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Salford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'student of MSc', 'investigatorFullName': 'Hanna Holmberg', 'investigatorAffiliation': 'University of Salford'}}}}