Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-04-17 @ 1:22 AM
Study NCT ID:
NCT01346995
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
2011-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-03', 'studyFirstSubmitDate': '2011-05-02', 'studyFirstSubmitQcDate': '2011-05-03', 'lastUpdatePostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isokinetic knee muscle strength', 'timeFrame': 'At baseline and after 8 weeks of exercise'}], 'secondaryOutcomes': [{'measure': 'One-leg chair rise', 'timeFrame': 'At baseline and after 8 weeks of exercise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Muscle Strength']}, 'referencesModule': {'references': [{'pmid': '21905254', 'type': 'DERIVED', 'citation': 'Sorensen TJ, Langberg H, Hodges PW, Bliddal H, Henriksen M. Experimental knee joint pain during strength training and muscle strength gain in healthy subjects: a randomized controlled trial. Arthritis Care Res (Hoboken). 2012 Jan;64(1):108-16. doi: 10.1002/acr.20618.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of experimental knee pain on the muscle strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized that experimental knee pain will reduce the muscle strength gain following strengthening exercises in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 20 to 35 years\n* healthy\n* untrained (non-regular exercise participation \\[i.e. \\< 1 day/week\\])\n\nExclusion Criteria:\n\n* symptomatic musculoskeletal diseases\n* history of traumatic injuries to muscles, tendons or joints of the lower extremity\n* knee joint pain within a month prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01346995', 'briefTitle': 'The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain', 'orgStudyIdInfo': {'id': '072.07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Knee Pain', 'description': 'Experimental knee pain induced by injections of 1 ml hypertonic saline in to the infrapatellar fat pad', 'interventionNames': ['Other: Experimental knee pain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'non-painful injections of isotonic saline into the infrapatellar fatpad.', 'interventionNames': ['Other: Non-painful control injections']}], 'interventions': [{'name': 'Experimental knee pain', 'type': 'OTHER', 'description': 'Injection of 1 ml hypertonic saline (5.8%) into the infrapatellar fat pad', 'armGroupLabels': ['Experimental Knee Pain']}, {'name': 'Non-painful control injections', 'type': 'OTHER', 'description': 'Injection of isotonic saline into the infrapatellar fat pad', 'armGroupLabels': ['Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frederiksberg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Henning Bliddal', 'oldOrganization': 'The Parker Institute'}}}}