Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 1:29 AM
Study NCT ID:
NCT05349994
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2022-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Physiotherapy After Intensive Care Unit (ICU) Stay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study design was a before and after study. A control group was included for three months and received standard care. An intervention group was then included for six months and received extended amount of physical therapy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-22', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in physical function according to Chelsea Critical Care Physical Assessment tool (CPAx)', 'timeFrame': 'Through study completion, an average of 2 weeks per participant', 'description': 'Measures physical function in critically ill patients'}], 'secondaryOutcomes': [{'measure': 'Feasibility of intervention', 'timeFrame': 'Through study completion, an average of 2 weeks per participant', 'description': 'Number of planned interventions not delivered, and number of safety events.'}, {'measure': 'Length of stay at the ward', 'timeFrame': 'Through study completion, an average of 2 weeks per participant', 'description': 'Number of days at the hospital ward after ICU discharge'}, {'measure': 'Readmission to ICU', 'timeFrame': 'Through study completion, an average of 2 weeks per participant', 'description': 'Number of readmissions to ICU from ward, within each study group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical therapy', 'Physical function'], 'conditions': ['Critical Illness', 'Physical Disability']}, 'descriptionModule': {'briefSummary': 'Patients in an Intensive Care Unit (ICU) are at great risk of muscle atrophy and neuromuscular complications, that could lead to respiratory complications, decreased physical functioning and deteriorated health related quality of life. The objective is to investigate if extended physical therapy in a general ward could lead to increased physical functioning for post-ICU patients.The study hypothesis is that extended physical therapy would lead to increased physical function at hospital discharge compared to standard amount of physical therapy.', 'detailedDescription': 'The study design is a before and after study. A control group was included for three months and received standard amount of physical therapy at surgical wards, corresponding to 1.75 employment. An intervention group was then included for six months and received extended amount of physical therapy corresponding to an extra 0.5 employment for study participants (2-4 patients/day). The primary outcome was physical function measured with the Chelsea Critical Care Physical Assessment Tool (CPAx), in the ICU and the surgical ward.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* ICU stay \\>48 hours\n* Understand the Swedish language\n\nExclusion Criteria:\n\n• Patients palliative care with no intention of rehabilitation'}, 'identificationModule': {'nctId': 'NCT05349994', 'briefTitle': 'Extended Physiotherapy After Intensive Care Unit (ICU) Stay', 'organization': {'class': 'OTHER', 'fullName': 'Stockholm South General Hospital'}, 'officialTitle': 'Extended Physiotherapy After Intensive Care Unit (ICU) Stay: A Prospective Before and After Study', 'orgStudyIdInfo': {'id': 'Improvement project AFE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard amount of physical therapy at surgical wards in an urban hospital, corresponding to 1.75 physiotherapy employment on weekdays divided on four wards with a total of approx. 40-48 patients.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Extended physiotherapy with an extra 0.5 employment on weekdays, leading to 1-2 physiotherapy session per day for the study participants in the intervention group.', 'interventionNames': ['Other: Extended physiotherapy']}], 'interventions': [{'name': 'Extended physiotherapy', 'type': 'OTHER', 'description': 'At admission to the surgical ward after ICU care, participants received an individual rehabilitation plan developed in collaboration with the participants and the ward-based physiotherapist. The rehabilitation plan included specified exercises for 1- 2 sessions of approximately 30 minutes a day. For example breathing exercises, practicing transfer in and out of bed and from sitting to standing, stairclimbing, and walking with or without walking aids.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11883', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Stockholm South General Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Katinka Siesage', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stockholm South General Hospital'}, {'name': 'Eva Alm- Joelsson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stockholm South General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data available on request due to privacy/ethical restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stockholm South General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RPT, Clinical Specialist Physiotherapist Intensive Care, MSc', 'investigatorFullName': 'Katinka Siesage', 'investigatorAffiliation': 'Stockholm South General Hospital'}}}}