Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT04144634
Status:
TERMINATED
Last Update Posted:
2021-01-14
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Additional Physiotherapy for Patients Aged 75 and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Terminated due to COVID-19', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Topic-guided interview of participants at discharge from hospital', 'timeFrame': 'At day 7 of hospitalisation (or at discharge if earlier)'}], 'secondaryOutcomes': [{'measure': 'Topic-guided semi-structured interview of the group of physiotherapy assistants who delivered the intervention', 'timeFrame': 'At day 7 of hospitalisation (or at discharge if earlier)'}, {'measure': 'Hand held dynamometry (Knee extension + grip strength)', 'timeFrame': 'At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge'}, {'measure': 'de Morton Mobility Index', 'timeFrame': 'At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge', 'description': 'Scale from 0-100, 100 representing highest functional ability'}, {'measure': 'Barthel Index', 'timeFrame': '6 weeks after discharge', 'description': 'Scale from 0-100, 100 representing highest functional ability'}, {'measure': 'Falls Efficacy Scale International', 'timeFrame': '6 weeks after discharge', 'description': 'Scale from 16-64, 16 representing highest perceived self efficacy of avoiding falling'}, {'measure': 'Confidence measured on a visual analogue scale', 'timeFrame': '6 weeks after discharge', 'description': 'Scale from 0-100, 100 representing highest level of confidence.'}, {'measure': 'Mini-Addenbrookes Cognitive Examination', 'timeFrame': '6 weeks after discharge', 'description': 'Scale from 0-30, 30 representing highest cognitive ability.'}, {'measure': 'Survey of Health, Ageing and Retirement in Europe (SHARE) Frailty Instrument', 'timeFrame': '6 weeks after discharge', 'description': 'A continuous scale, with a higher number representing a higher degree of frailty'}, {'measure': 'Physical activity in hospital', 'timeFrame': '6 weeks after discharge', 'description': 'Measured with accelerometers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise', 'Hospitalisation', 'Older Adults']}, 'descriptionModule': {'briefSummary': "On average, people become physically weaker during even a short stay in hospital. This study is a feasibility/pilot study to see if additional physiotherapy exercises undertaken in hospital is feasible and acceptable to patients.\n\nThe study will compare two different types of physiotherapy exercise. Both exercise programmes involve twice-daily physiotherapy provided by one of the hospital's physiotherapy assistants, but only one of the two exercise programmes expected to provide benefit. This is on top of the care that people would normally receive, and will last for the first 7 days of their hospital admission (or until they are discharged if this is earlier).\n\nPatients will be asked to consent to the study during the first 36 hours of their hospital admission. If patients provide consent, they will undergo a baseline assessment of their functional ability (including testing of their muscle strength) before being randomly assigned to one of the two exercise programmes. The study aims to recruit 15 patients to each group (30 in total).\n\nOnce randomised patients will be seen twice a day by a physiotherapy assistant who will supervise the exercise programme.\n\nOn the day that participants are discharged (or day 7 of their admission if earlier) the assessor will repeat measures of the participants functional ability. Following these measures participants will be invited to be interviewed to discuss their experience of taking part in the study.\n\nApproximately one month after discharge, a researcher will visit the participant to repeat measures of their functional ability at their home."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to CUH, who are aged 75 or older, able to give informed consent and expected to be hospitalised more than 24 hours.\n\nExclusion Criteria:\n\n* Admitted more than 36 hours prior to recruitment; unable to provide informed consent (e.g. due to dementia, delirium, cognitive impairment); receiving end of life care or oncological treatment for diagnosed cancer; inability to cooperate in muscle strength testing (e.g. unable to sit in chair, or presence of skin integrity problems contraindicating the use of a hand-held dynamometer); transferred to or from the intensive care unit; bed-bound or requiring a hoist to transfer from bed to chair 2 weeks prior to hospitalisation; or if the Consultant in charge of the patient has any other clinical concerns regarding participation in a strengthening exercise programme.'}, 'identificationModule': {'nctId': 'NCT04144634', 'acronym': 'Stand-UP', 'briefTitle': 'Feasibility of Additional Physiotherapy for Patients Aged 75 and Older', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Pilot Study of an Exercise Programme to Maintain Knee Extension Muscle Strength for Older Patients During Hospitalisation', 'orgStudyIdInfo': {'id': 'A095191'}, 'secondaryIdInfos': [{'id': '252802', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention/Strengthening', 'interventionNames': ['Other: Strengthening exercises']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control/Stretching', 'interventionNames': ['Other: Stretching exercises']}], 'interventions': [{'name': 'Strengthening exercises', 'type': 'OTHER', 'description': 'The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of progressive resistance training based around the movement of standing up/sitting down.', 'armGroupLabels': ['Intervention/Strengthening']}, {'name': 'Stretching exercises', 'type': 'OTHER', 'description': 'The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of gentle stretching of upper limbs and lower limbs.', 'armGroupLabels': ['Control/Stretching']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cambridge', 'class': 'OTHER'}, {'name': 'University of Dublin, Trinity College', 'class': 'OTHER'}, {'name': 'The Dunhill Medical Trust', 'class': 'OTHER'}, {'name': "Addenbrooke's Charitable Trust", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Peter Hartley', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}