Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-03 @ 4:31 AM
Study NCT ID:
NCT06341920
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-13', 'size': 218343, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-12T06:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention v control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': '2 years', 'description': 'Number of people recruited and trained'}, {'measure': 'Adherence and attendance', 'timeFrame': '2.5 years', 'description': 'Record the number of sessions attended and calculate adherence to protocol (%)'}, {'measure': 'Acceptability', 'timeFrame': '3 years', 'description': 'Conduct semi-structured interviews following the intervention with sample of participants and ask them about experiences of the intervention. The post-intervention interviews will focus on how participants viewed the intervention, perceived burdens, and perceived effectiveness from initiation through to completion. A list of burdens / perceived benefits will be reported alongside percentage rates of respondents.'}], 'secondaryOutcomes': [{'measure': 'Physical fitness', 'timeFrame': '3 years', 'description': 'Compare incremental shuttle walk test scores (intervention v controls). Units: stage achieved and time taken (seconds)'}, {'measure': 'Length of stay', 'timeFrame': '3 years', 'description': 'Compare days in hospital following surgery (intervention v controls). Units: hours in hospital following surgery.'}, {'measure': 'Readmission rates', 'timeFrame': '3 years', 'description': 'Compare the % of patients in each group who were readmitted to hospital following surgery (intervention v controls)'}, {'measure': 'Overall quality of life', 'timeFrame': '3 years', 'description': 'Compare quality of life scores (intervention v controls) using EQ-5D-5L questionnaire. Index scores range between zero and one, based on 5-point Likert scale, with scores closer to one indicating an improved status.'}, {'measure': 'Knee or hip specific pain, function and quality of life', 'timeFrame': '3 years', 'description': 'Compare knee or hip specific quality of life scores (intervention v controls). For knee replacements, the KOOS-12 is scored between 0-100 on 5-point Likert scale, with higher scores equating to improved status. For hip replacements, HOOS-12 scores between 0 to 4 points with 0 representing no hip problems and 4 representing extreme hip problems, based on response to 5-point Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prehabilitation', 'optimisation', 'surgery', 'surgical preparation'], 'conditions': ['Orthopedic Disorder']}, 'referencesModule': {'references': [{'pmid': '39937759', 'type': 'DERIVED', 'citation': 'Ingle L, Snook J, Smith L, Oliver B, Bray J, Wells L, Moorhouse J, Dixon L, Simpson P, Osman S, Saxton J, Rajendran A, Gopalakrishnan G, Symes T. Optimisation of the preparation phase for orthopaedic surgery: Study protocol for a student-led multimodal prehabilitation feasibility trial (BoneFit). PLoS One. 2025 Feb 12;20(2):e0314680. doi: 10.1371/journal.pone.0314680. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery.', 'detailedDescription': 'The aim of BoneFit is to provide local people living in the Hull region with a needs-based prehabilitation care package to improve their physical and mental health, quality of life \\& reduce their length of hospital stay, complications and readmission rates to hospital following orthopaedic surgery (total hip replacement, or total knee replacement.\n\nCurrently, Hull University Teaching Hospitals do not offer a prehabilitation service for local patients. The University of Hull will partner with them to provide a student-led multimodal prehabilitation service for referred patients awaiting orthopaedic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;\n* Able to provide informed consent;\n\nExclusion Criteria:\n\n* Previous hip or knee surgery;\n* Any medical conditions for which moderate to vigorous exercise is contraindicated;\n* Patellar or hip joint instability;\n* Any other disease/condition which severely effects functional performance e.g. stroke or Parkinson's disease;\n* Chronic depression or significant psychiatric disorder;\n* Enrolled in a clinical trial (or recently completed one);\n* Cognitive impairment which would affect compliance to BoneFIt service;\n* Patients unable or unwilling to commit to required study follow-ups\n* Pregnancy;"}, 'identificationModule': {'nctId': 'NCT06341920', 'acronym': 'BoneFit', 'briefTitle': 'BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Hull'}, 'officialTitle': 'BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull', 'orgStudyIdInfo': {'id': 'RS198 - 332551'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BoneFit intervention', 'description': 'Participants will receive a personalised care plan comprising exercise, nutrition and psychological wellbeing based on individual need in the 8-week period prior to surgery', 'interventionNames': ['Behavioral: Experimental: BoneFit intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Participants who are allocated to this group will receive baseline tests and will be invited to re-attend 3 months post surgery to re-do tests. This group will receive usual care (no intervention). The groups will be compared.', 'interventionNames': ['Behavioral: Placebo Comparator: Control']}], 'interventions': [{'name': 'Experimental: BoneFit intervention', 'type': 'BEHAVIORAL', 'description': 'Exercise, nutrition and psychological support provided in 8 weeks prior to surgery', 'armGroupLabels': ['BoneFit intervention']}, {'name': 'Placebo Comparator: Control', 'type': 'BEHAVIORAL', 'description': 'Control group receive usual care (zero intervention)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hull', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Lee Ingle', 'role': 'CONTACT', 'email': 'L.Ingle@hull.ac.uk'}], 'facility': 'Hull University Teaching Hospitals', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}], 'centralContacts': [{'name': 'Lee Ingle', 'role': 'CONTACT', 'email': 'L.Ingle@hull.ac.uk', 'phone': '01482 463141'}], 'overallOfficials': [{'name': 'Lee Ingle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Exercise Science for Health and Rehabiliation'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Dec 2027', 'ipdSharing': 'YES', 'description': 'Please contact the PI and request access to data', 'accessCriteria': 'Request from PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hull', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}