Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-30 @ 7:47 AM
Study NCT ID:
NCT05859360
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2023-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Exercise Training in Cerebral Palsy: Follow Up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076604', 'term': 'Physical Functional Performance'}], 'ancestors': [{'id': 'D010809', 'term': 'Physical Fitness'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-04', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum knee extension force', 'timeFrame': '20 minutes', 'description': 'Maximum force of knee extension in relation to body weight'}], 'secondaryOutcomes': [{'measure': 'Microvascular health', 'timeFrame': '5 minutes', 'description': 'Static retinal vessel analysis'}, {'measure': 'Voluntary activation', 'timeFrame': '15 minutes', 'description': 'Maximum force able to voluntarily activate'}, {'measure': 'Spiroergometry', 'timeFrame': '20 minutes', 'description': 'Cardiopulmonary test on bicycle ergometer'}, {'measure': 'Muscle architecture', 'timeFrame': '10 minutes', 'description': 'Ultrasound of defined muscle groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['functional training', 'strength', 'cardiovascular health', 'cerebral palsy'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The goal of this cross-sectional study is to compare able-bodied peers to adolescents and young adults with cerebral palsy (CP) who have been regularly performing high-intensity functional training for almost two years.\n\nThe main research question is: is structured, long-term exercise training able to compensate strength and cardiovascular deficits in adolescents with CP compared to able-bodied peers?', 'detailedDescription': 'The pilot study investigating the effects of a functional exercise training in adolescents and young adults with cerebral palsy (CP) showed increases in strength, power, daily function as well as cardiovascular health. In order to establish the origin of the improvements and its broader effects, we wish to conduct follow-up measurements to the pilot study. These follow-up measurements would establish whether the positive changes in physical performance are due to neural or muscular changes (or both), and shed more light on how therapy should be performed and prescribed in adolescents with CP. Additionally, we wish to measure their aerobic capacity as well as examine their microvascular health. For this cross-sectional analysis, the participants of the CP-FIT Pilot Study who continued to train on a regular basis will be compared to age-matched peers in order to establish whether their strength and fitness deficits compared to peers can be compensated through structured and progressive functional exercise training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '27 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The group adolescents with CP consists of individuals from the CP-FIT pilot study who have both continued or discontinued their training after study completion. Healthy peers are age- and sex-matched able-bodied peers.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nCP Individuals:\n\n* Diagnosis of CP.\n* Between 14 and 26 years of age.\n* Gross Motor Functional Classification System (GMFCS): I-II.\n* Cognitive abilities must include: Ability to verbally or non-verbally communicate pain or discomfort; Ability to attend testing and; ability to understand and follow instructions. All included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations.\n\nHealthy peers:\n\n\\- Between 14 and 26 years of age.\n\nExclusion Criteria:\n\nCP Individuals:\n\n* Any surgery or botulinum toxin treatment within 6 months prior to the measurements or scheduled during study period. Other medications can be continued as prescribed by the participants' physician.\n* Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in physical exercise.\n* Uncontrolled seizures or epilepsy.\n* Inability to conform to the above mentioned cognitive and physical abilities.\n\nHealthy peers:\n\n* Diagnosis of congenital heart defects, pulmonary diseases or any neuromuscular disorders or diseases.\n* Diagnosis of any acute diseases."}, 'identificationModule': {'nctId': 'NCT05859360', 'acronym': 'FITCP', 'briefTitle': 'Functional Exercise Training in Cerebral Palsy: Follow Up', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Functional Exercise Training With Adolescents and Young Adults With Cerebral Palsy: Follow Up Study', 'orgStudyIdInfo': {'id': 'FITCP: Follow Up'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trained CP', 'description': 'Adolescents and young adults with CP who have continued their regular training after completing the pilot study.', 'interventionNames': ['Other: Physical performance and cardiovascular health measures']}, {'label': 'Untrained CP', 'description': 'Adolescents and young adults with CP who have not continued their regular training after completing the pilot study.', 'interventionNames': ['Other: Physical performance and cardiovascular health measures']}, {'label': 'Trained Peers', 'description': 'Healthy peers who perform high-intensity strength training on a regular basis.', 'interventionNames': ['Other: Physical performance and cardiovascular health measures']}, {'label': 'Untrained Peers', 'description': 'Healthy peers who do not perform high-intensity strength training on a regular basis.', 'interventionNames': ['Other: Physical performance and cardiovascular health measures']}], 'interventions': [{'name': 'Physical performance and cardiovascular health measures', 'type': 'OTHER', 'description': '* Retinal vessel analysis\n* Muscle ultrasound\n* Knee extension\n* Voluntary activation\n* spiroergometry', 'armGroupLabels': ['Trained CP', 'Trained Peers', 'Untrained CP', 'Untrained Peers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4052', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Department of Sport, Exercise and Health, University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be made public. Group data will be analysed for publication after study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Basel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. sc. med.', 'investigatorFullName': 'Alice Minghetti', 'investigatorAffiliation': 'University of Basel'}}}}