Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-31 @ 1:59 AM
Study NCT ID:
NCT05290532
Status:
UNKNOWN
Last Update Posted:
2022-03-22
First Post:
2022-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The study participants will be randomized ( ww. randomizer.org) into an intervention group and a control group. the assessment staff will be blinded to the participant randomization assignment, as well as to the main study design ant to what changes we expect to occur in the study outcomes in either group.\n\nIt will not be possible to conceal the group assignment from the staff involved in the training of the intervention group.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized clinical trial,patient who meet the inclusion criteria will be randomly assigned to the intervention or control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-13', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-03-13', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in functional capacity of patients', 'timeFrame': '1, 3 and 6 months after hospitalization discharge', 'description': 'The functional capacity of patients will be evaluated by the Short Physical Performance Battery (SPPB), which evaluates, balance, gait ability, and leg strength using a single tool. The total score will range from 0 (worst) to 12 points (best).'}, {'measure': 'Changes in Cognitive capacity of patients', 'timeFrame': '1, 3 and 6 months after hospitalization discharge', 'description': 'The cognitive-affective status will be measured in the follow up using the Mini Mental State Examination.nThis examination is composed of seven categories designed to assess specific cognitive functions: orientation to time (5 points), orientation to place (5 points), registration of three words (3 points), attention and calculation (5 points), recalling the three words (3 points), language (8 points) and constructive visual capacity (1 point). The MMSE score ranges from zero to 30 points, and lower values indicate possible cognitive deficit'}, {'measure': 'Changes in Quality of life', 'timeFrame': '1, 3 and 6 months after hospitalization discharge', 'description': 'Changes in Quality of life will be evaluated by European Quality of Life-5 Dimensions (EuroQol- 5D).\n\nEuropean Quality of Life-5 Dimensions: comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels, the score will range from 5 (wort) to 15 (best).'}, {'measure': 'Changes in Visual Analogue Scale', 'timeFrame': '1, 3 and 6 months after hospitalization discharge', 'description': "Changes in Visual Analogue Scale (VAS). The VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (100 points) and 'The worst health you can imagine'(0 points)."}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 and 90-day', 'description': 'Comprehensive Complication Index'}, {'measure': 'Length of stay', 'timeFrame': 'from the date of admission until the date of discharge', 'description': 'Length of stay'}, {'measure': 'Mortality', 'timeFrame': '30 and 90-day', 'description': 'postoperative mortality'}, {'measure': 'Delirium', 'timeFrame': 'from the date of admission until the date of discharge', 'description': 'Confusion Assessment Method (CAM) The CAM short form assesses four features: 1. acute onset or fluctuating course, 2. inattention, 3. disorganized thinking, and 4. altered level of consciousness. For the diagnosis of delirium, the first two criteria and at least one of the last two are necessary.'}, {'measure': 'Cost per quality-adjusted life year', 'timeFrame': '6 months post-discharge', 'description': 'Both direct and indirect study participant costs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly patients', 'Exercises', 'Cognitive Dysfunction', 'Quality of life'], 'conditions': ['Surgery--Complications']}, 'referencesModule': {'references': [{'pmid': '39232792', 'type': 'DERIVED', 'citation': 'Esquiroz Lizaur I, Zambom-Ferraresi F, Zambom-Ferraresi F, Ollo-Martinez I, De la Casa-Marin A, Martinez-Velilla N, Recreo Baquedano A, Galbete Jimenez A, Gonzalez Alvarez G, Yarnoz Irazabal MC, Eguaras Cordoba I. Postoperative physical rehabilitation in the elderly patient after emergency surgery. Influence on functional, cognitive and quality of live recovery: study protocol for a randomized clinical trial. Trials. 2024 Sep 4;25(1):584. doi: 10.1186/s13063-024-08406-0.'}]}, 'descriptionModule': {'briefSummary': 'Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery.\n\nThese patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory', 'detailedDescription': 'This study is a randomized clinical trial conducted in the Department of Surgery of a tertiary public hospital. Patients undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. A total of 218 elderly patients undergoing urgent abdominal surgery( control group=109 and intervention group 109) randomly assigned to the intervention or control group.\n\nPatient recruitment will begin in the 4-day after the surgical procedure, which will be identified through the list of patients admitted to the hospital and assigned to the Department. The doctor who decides the inclusion in the intervention or control group will not be the attending physician. Patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. Randomization will be performed by applying http://www.randomizer.org/. The information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 1, 3 and 6 after hospital discharge.\n\nThe intervention will consist of a multicomponent exercise training program, which will composed of supervised progressive resistance exercise training, aerobic and anaerobic exercises. This training period consist on 2 training sessions per week during 4 weeks after one week of discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 70 years and older\n* Able to tolerate exercise\n* Able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair\n* Able to communicate\n* Undergoing urgent abdominal surgery\n* Barthel Index\\>60\n* Informed consent: must be capable and willing to provide consent\n\nExclusion Criteria:\n\n* Severe dementia (GDS 7)\n* Duration of hospitalization \\<4 days\n* Unwillingness to either complete the study requirements or to be randomized into control or intervention group\n* Unstable cardiovascular disease or other unstable medical condition\n* Terminal illness\n* Myocardial infarction in the past 3 months\n* Upper or lower extremity fracture in the past 3 months\n* Evisceration'}, 'identificationModule': {'nctId': 'NCT05290532', 'briefTitle': 'Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline', 'organization': {'class': 'OTHER', 'fullName': 'Hospital of Navarra'}, 'officialTitle': 'Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline, in Elderly Patients Undergoing Urgent Abdominal Surgery: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Hospital de Navarra'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Individualized exercise training', 'description': 'Exercise training. Individual program training 2 days per week during 4 week, after one week of discharge', 'interventionNames': ['Other: Individualized exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention: Control', 'description': 'Usual care including rehabilitation when necessary'}], 'interventions': [{'name': 'Individualized exercise training', 'type': 'OTHER', 'description': 'The intervention will consist of a multicomponent exercise training program, which will composed of supervised progressive resistance exercise training, aerobic and anaerobic exercises. This training period consist on 2 training sessions of 40 minutes (Warm up 5´+ aerobic exercise 15´+ anaerobic exercise 15´+ stretching 5´)per week during 4 weeks after one week of discharge', 'armGroupLabels': ['Individualized exercise training']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Inés E Córdoba, MD', 'role': 'CONTACT', 'email': 'ineseguaras@hotmail.com', 'phone': '666909487'}], 'overallOfficials': [{'name': 'IRENE ESQUIROZ, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital of Navarra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital of Navarra', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacion Miguel Servet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'IRENE ESQUIROZ', 'investigatorAffiliation': 'Hospital of Navarra'}}}}