Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT01290705
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2011-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092462', 'term': 'Patella Fracture'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092443', 'term': 'Knee Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2011-02-04', 'studyFirstSubmitQcDate': '2011-02-04', 'lastUpdatePostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain measured by a Visual analogue scale (VAS).', 'timeFrame': 'Pre-test, post-test (after completed intervention at 3 months) and one year follow-up.', 'description': 'This scale was illustrated with a 100 mm horizontal line with descriptors "no pain" at the 0 mm mark and "worst pain imaginable" anchoring the 100 mm. Participants were required to place a vertical mark on the horizontal line, representing their average level of pain experienced during the last 24 hours. This was done at rest and provided an illustration of the perceived pain severity, rated in millimetres.'}], 'secondaryOutcomes': [{'measure': 'Function measured by a Step-down test and by a modified Functional Index Questionnaire (FIQ).', 'timeFrame': 'Pre-test, post-test (at 3 months after completed intervention) and at one year follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee', 'Anterior Cruciate Ligament', 'Pain', 'Patella', 'Exercise Therapy'], 'conditions': ['Patellofemoral Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '23764516', 'type': 'RESULT', 'citation': 'Osteras B, Osteras H, Torstensen TA. Long-term effects of medical exercise therapy in patients with patellofemoral pain syndrome: results from a single-blinded randomized controlled trial with 12 months follow-up. Physiotherapy. 2013 Dec;99(4):311-6. doi: 10.1016/j.physio.2013.04.001. Epub 2013 Jun 10.'}, {'pmid': '23219636', 'type': 'RESULT', 'citation': 'Osteras B, Osteras H, Torstensen TA, Vasseljen O. Dose-response effects of medical exercise therapy in patients with patellofemoral pain syndrome: a randomised controlled clinical trial. Physiotherapy. 2013 Jun;99(2):126-31. doi: 10.1016/j.physio.2012.05.009. Epub 2012 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'With this study two different therapeutic exercise regimens will be compared in patients with anterior knee pain (patellofemoral pain syndrome, PFPS).', 'detailedDescription': 'Exercise therapy is widely used in the conservative treatment of patellofemoral pain syndrome (PFPS), but there is still no consensus on recommending any specific rehabilitation program.\n\nThis study evaluates two different therapeutic exercise regimens in patients with PFPS and their effect on pain at rest and function.\n\nSupervised exercise therapy will be applied in both groups three times a week over a 3-month period with individually tailored and graded exercise programs, differing between groups in terms of number of exercises, number of repetitions and sets, and time spent on performing aerobic exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Presence of at least 3 symptoms of the following:\n\nPain when\n\n* Walking stairs\n* Squatting\n* Running\n* Cycling\n* Sitting with knees flexed for a prolonged period of time\n* Grinding of the patella\n* Other positive physical tests (Clarke's test, patellar crepitus, tenderness upon palpation of the posterior surface of the patella, patellar facets or surrounding structures)\n\nExclusion Criteria:\n\n* Knee osteoarthrosis/ arthritis\n* previous knee injury or knee operations\n* patellar tendinopathy\n* Osgood- Schlatter's disease\n* Other defined pathological conditions of the knee"}, 'identificationModule': {'nctId': 'NCT01290705', 'briefTitle': 'Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome. A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '17790'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high exercise', 'description': 'High dose, high repetition exercise therapy, 3 times weekly in 12 weeks', 'interventionNames': ['Behavioral: High exercise therapy']}, {'type': 'EXPERIMENTAL', 'label': 'low exercise', 'description': 'low dose, low repetition exercise therapy, 3 times weekly in 12 weeks', 'interventionNames': ['Behavioral: Low exercise therapy']}], 'interventions': [{'name': 'High exercise therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['high exercise']}, {'name': 'Low exercise therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['low exercise']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jan Harry Størksen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}