Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-28 @ 6:30 PM
Study NCT ID:
NCT05665257
Status:
COMPLETED
Last Update Posted:
2022-12-27
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-16', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of preoperative inspiratory muscle training', 'timeFrame': 'The different outcome measures are assessed continuously during a period from inclusion until discharge from the hospital. This period varied in length (3 weeks-3 months) depending on when participants were scheduled for surgery.', 'description': 'Feasibility will be assessed using two domains: process and scientific feasibility. These domains include several parts such as recruitment rates, time available for training, intervention adherence, patient acceptability, pre-and postoperative respiratory muscle and lung function assessments, reproducibility of assessments, preliminary treatment effect, incidence of PPCs, and adverse events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peritoneal Metastases']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled feasibility study was to evaluate the feasibility of preoperative inspiratory muscle training in patients undergoing surgery because of peritoneal metastases.\n\nThe main questions it aimed to answer was how feasible the intervention is regarding process and scientific feasibility as defined by Thabane et al 2010.\n\nParticipants in the intervention group were using a handheld device to increase their inspiratory muscle strength prior to surgery and researchers compared this group to a control group who were offered a sham treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy\n\nExclusion Criteria:\n\n* Surgery scheduled less than two weeks from the date of inclusion\n* Inability to speak and understand Swedish'}, 'identificationModule': {'nctId': 'NCT05665257', 'briefTitle': 'Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Preoperative Inspiratory Muscle Training for Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - a Feasibility Study', 'orgStudyIdInfo': {'id': 'Ethical approval no 2016/338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inspiratory muscle training', 'description': "Participants in the intervention group were using a handheld device, Powerbreathe K3, aiming at increasing inspiratory muscle strength by applying an inspiratory resistance. They were instructed to use it twice a day for at least 14 days. Starting load was based on the baseline assessment of the participant's inspiratory muscle strength and increased during the intervention period.", 'interventionNames': ['Device: Inspiratory muscle training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Mini-PEP', 'description': 'Participants in the control arm were instructed to use a handheld PEP-device traditionally used to facilitate deep breathing. The PEP-device does not provide any inspiratory resistance and therefore, it was considered a sham treatment. The control group were also instructed to use the device twice a day for at least two weeks.', 'interventionNames': ['Device: Mini-PEP']}], 'interventions': [{'name': 'Inspiratory muscle training', 'type': 'DEVICE', 'armGroupLabels': ['Inspiratory muscle training']}, {'name': 'Mini-PEP', 'type': 'DEVICE', 'armGroupLabels': ['Mini-PEP']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mikael Andersson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified data will be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}