Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-02 @ 2:50 PM
Study NCT ID:
NCT03096067
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2017-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) at 12 wks', 'timeFrame': '0-12 wks', 'description': 'Patient reported outcome regarding symptoms, function and the ability to participate in sports'}], 'secondaryOutcomes': [{'measure': 'Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P)', 'timeFrame': '0 and 6 wks + 1 yr follow up + Long-term follow-up (2-4 yr)', 'description': 'Patient reported outcome regarding symptoms, function and the ability to'}, {'measure': 'Pain rating on numeric rating scale (NRS) and activity level of sporting activities (h/wk)', 'timeFrame': '0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)', 'description': 'Questionnaire'}, {'measure': 'Tendon thickness and Doppler activity', 'timeFrame': '0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)', 'description': 'Measured by ultrasound'}, {'measure': 'Single-leg decline squat (SLDS) test', 'timeFrame': '0,6, 12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)', 'description': 'A reliable patellar tendon pain provocation test, will be used to assess pain during function'}, {'measure': 'Jump test', 'timeFrame': '0 and 12 wks', 'description': 'Squat jump and Counter movement Jump will be used to assess patellar tendinopathy caused functional deficits on the injured site compared with the non-injured site'}, {'measure': 'Mechanical properties', 'timeFrame': '0 and 12 wks', 'description': 'Synchronized tendon elongation with the use of ultrasonography along with force measures, will be used during voluntary contractions to determine mechanical properties'}, {'measure': 'Muscle strength', 'timeFrame': '0 and 12 wks', 'description': 'Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions'}, {'measure': 'Tendon dimensions and structure', 'timeFrame': '0 and 12 wks', 'description': 'Measured by MRI'}, {'measure': 'Treatment satisfaction', 'timeFrame': '12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr)', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patellar Tendinopathy', "Jumper's Knee"]}, 'referencesModule': {'references': [{'pmid': '33616456', 'type': 'DERIVED', 'citation': 'Agergaard AS, Svensson RB, Malmgaard-Clausen NM, Couppe C, Hjortshoej MH, Doessing S, Kjaer M, Magnusson SP. Clinical Outcomes, Structure, and Function Improve With Both Heavy and Moderate Loads in the Treatment of Patellar Tendinopathy: A Randomized Clinical Trial. Am J Sports Med. 2021 Mar;49(4):982-993. doi: 10.1177/0363546520988741. Epub 2021 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to investigate if the magnitude of a loading based 12 weeks rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon structure and function.\n\nThe investigators hypothesize that a greater magnitude (90% of 1RM) of loading will yield a more positive clinical outcome, tendon structure and function in patients with patellar tendinopathy compared to a lower magnitude of loading (55% of 1 RM) when total exercise volume is equal in both groups.', 'detailedDescription': 'Randomized controlled intervention study with one year follow-up'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uni- or bilateral patellar tendinopathy\n* Symptoms \\> 3 months\n* Ultrasonographical tendon swelling\n* Ultrasonographical hypo-echoic area with doppler\n* BMI 18.5-30\n\nExclusion Criteria:\n\n* Patellar tendinopathy \\> 12 month\n* Previous knee surgery\n* Confounding diagnosis to the knee joint\n* Diabetes or arthritis\n* Previous corticosteroid injection for patellar tendinopathy\n* Smoking\n* Being elite volleyball players'}, 'identificationModule': {'nctId': 'NCT03096067', 'briefTitle': 'Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Treatment of Patellar Tendinopathy; Influence of Load Magnitude on Clinical Outcome, Tendon Structure and Function', 'orgStudyIdInfo': {'id': 'BBH131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Heavy slow resistance group', 'description': 'Heavy slow resistance training. Three times weekly for 12 weeks.', 'interventionNames': ['Other: Heavy slow resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate slow resistance group', 'description': 'Moderate slow resistance training. Three times weekly for 12 weeks.', 'interventionNames': ['Other: Moderate slow resistance training']}], 'interventions': [{'name': 'Heavy slow resistance training', 'type': 'OTHER', 'description': 'Resistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition).', 'armGroupLabels': ['Heavy slow resistance group']}, {'name': 'Moderate slow resistance training', 'type': 'OTHER', 'description': 'Resistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition).', 'armGroupLabels': ['Moderate slow resistance group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Peter Magnusson, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bispebjerg Hospital, University of Copenhagen'}, {'name': 'Anne-Sofie Agergaard, Phd.Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student, MSc. in Physiotherapy, PT', 'investigatorFullName': 'Anne-Sofie Agergaard', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}