Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-03-01 @ 8:54 PM
Study NCT ID:
NCT03737903
Status:
UNKNOWN
Last Update Posted:
2018-11-13
First Post:
2018-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Pre-operative Activity Levels in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring physical activity, defined as daily average activity-related acceleration (expressed in relative gravity, milligravity) in high risk elderly patients in the preoperative period using wrist worn accelerometers.', 'timeFrame': '2 weeks', 'description': 'This will be measured using a wrist worn accelerometer device to measure daily average activity-related acceleration expressed in relative gravity, milligravity.'}], 'secondaryOutcomes': [{'measure': 'Objective measurement of baseline physical activity levels using a wrist worn triaxial accelerometer, across different surgical specialties, thereby obtaining data on the variation in physical activity, expressed in relative gravity (milligravity).', 'timeFrame': '2 weeks', 'description': 'Measurement of baseline physical activity levels using a wrist worn triaxial accelerometer, across different surgical specialties, thereby obtaining data on the variation in physical activity, expressed in relative gravity (milligravity).'}, {'measure': 'Measure total daily physical activity, expressed in relative gravity (milligravity), using a wrist-worn triaxial accelerometer, before and after current preoperative intervention occuring as part of routine medical care.', 'timeFrame': '2 weeks', 'description': 'Measure total daily physical activity, expressed in relative gravity (milligravity), using a wrist-worn triaxial accelerometer,for one week before and one week after current preoperative intervention occurring as part of routine medical care. This will measure any change in physical activity from baseline to one week post intervention (therefore measured over a total time period of 2 weeks) as part of routine medical care'}, {'measure': 'Correlation between objectively measured physical activity and patient reported physical activity', 'timeFrame': '2 weeks', 'description': 'To determine any correlation between measured physical activity (expressed in relative gravity, milligravity), and patient reported physical activity (expressed using the PASE score) measured using appropriate correlation statistics'}, {'measure': 'Subjective measurement of baseline physical activity levels using validated self-reported physical activity questionnaire, across different surgical specialties.', 'timeFrame': '2 weeks', 'description': 'Subjective measurement of baseline physical activity levels using validated self-reported physical activity questionnaire, across different surgical specialties, thereby obtaining data on the variation in physical activity measured by the Physical Activity Scale for the Elderly (PASE) score. PASE comprises measures of self-reported occupational, household, and leisure activities during a one-week period. Scores range from 0 to 400 with a higher score indicating a higher level of physical activity'}, {'measure': 'Determine participant compliance in wearing the accelerometer device', 'timeFrame': '2 weeks', 'description': 'This will be measured by recording the total wear time (in hours) of the device during the study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frail elderly', 'Accelerometer', 'Preoperative assessment'], 'conditions': ['Surgery', 'Physical Activity', 'Aging']}, 'referencesModule': {'references': [{'pmid': '31685513', 'type': 'DERIVED', 'citation': 'Grimes L, Outtrim JG, Griffin SJ, Ercole A. Accelerometery as a measure of modifiable physical activity in high-risk elderly preoperative patients: a prospective observational pilot study. BMJ Open. 2019 Nov 3;9(11):e032346. doi: 10.1136/bmjopen-2019-032346.'}]}, 'descriptionModule': {'briefSummary': "The investigators aim to determine whether a wrist-worn accelerometer device is able to objectively measure physical activity, and whether it is an acceptable process for high-risk elderly patients prior to planned surgery. Accelerometers measure physical activity in 'counts' of activity, enabling them to record the total amount of activity in a given time period (e.g. number of steps per day), and also the time spent in various levels of intensity of activity. The investigators will ask study participants to wear an accelerometer around their wrist (like a wristwatch) for up to 14 days prior to their surgery. Participants will receive the same care as non-participants. Part of this routine medical care includes a preoperative review by a multidisciplinary team including specific personalised advice to optimise physical activity before surgery. The investigators will measure the impact that this existing intervention has on physical activity levels. Being more physically active is good for our health, and may be associated with a better recovery from surgery. In the future there may be methods of improving physical activity in the period of time before patients' surgery, which may improve their recovery from surgery.\n\nIn order to study this further, the investigators first need a robust and objective way of measuring physical activity. In current practice patients are asked to estimate how physically active they are on a day-to-day basis. This relies on how well they remember, and how good they are at getting it right and may not be accurate. The wrist-worn accelerometer is an objective method of measuring physical activity in patients, which not only offers greater understanding of the physical activity levels of elderly patients before a variety of operations, but also offers the opportunity to measure the impact of existing and potential future interventions to modify physical activity in the preoperative period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators are aiming to recruit approximately 50 high-risk patients aged 65 years and above, prior to major or complex elective surgery.\n\n"High-risk" is determined by Rockwood Clinical Frailty Score ≥4. Major or complex surgery is defined in NICE guideline (NG45).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 65 years or above\n* Rockwood frailty score of ≥4\n* Listed for elective major or complex surgery at Cambridge University Hospitals NHS Foundation Trust\n* Capacity to consent and complete activity questionnaires\n* Willing and able to wear accelerometer around wrist\n\nExclusion Criteria:\n\n* Does not meet the inclusion criteria\n* Participant refusal\n* PRIME clinic appointment scheduled less than 72hrs after the nurse led pre-assessment clinic'}, 'identificationModule': {'nctId': 'NCT03737903', 'briefTitle': 'Understanding Pre-operative Activity Levels in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Preoperative Use of Wrist-worn Accelerometers to Measure Physical Activity in High-risk Elderly Patients', 'orgStudyIdInfo': {'id': 'A094782'}, 'secondaryIdInfos': [{'id': '238840', 'type': 'OTHER', 'domain': 'IRAS Number'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB20QQ', 'city': 'Cambridge', 'state': 'Cambs', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ari Ercole, PhD', 'role': 'CONTACT', 'phone': '01223 217889'}], 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Lisa Grimes', 'role': 'CONTACT', 'email': 'lag31@cam.ac.uk', 'phone': '01223 274446'}], 'overallOfficials': [{'name': 'Ari Ercole', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joanne Outtrim', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cambridge', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Research Nurse', 'investigatorFullName': 'Joanne Outtrim', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}