Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02914093
Status:
TERMINATED
Last Update Posted:
2019-10-08
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMT in Hypercapnic Patients With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006935', 'term': 'Hypercapnia'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-04', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completed training sessions', 'timeFrame': '6 weeks', 'description': 'Feasibility - if 80% of the planned training sessions have been completed'}, {'measure': 'Changes i Pimax', 'timeFrame': '6 weeks', 'description': 'Feasibility - if the maximum inspiratory strength measured in cmH2O improves by an average of 10 %'}, {'measure': 'Experienced discomfort', 'timeFrame': '6 weeks and during the training session', 'description': 'Feasibility - if the patients do not experience any discomfort or increased dyspnea during and after training'}], 'secondaryOutcomes': [{'measure': 'Changes in pCO2', 'timeFrame': '6 weeks', 'description': 'Arterial bloodgas analysis at day 1 and day 42 to measure pCO2 in kPa before and after the intervention'}, {'measure': '6 minutes walking test', 'timeFrame': '6 weeks', 'description': '6 MWT assess the distance walked over six minutes as a sub-maximal test of aerobic capacity/ endurance'}, {'measure': 'CAT', 'timeFrame': '6 week', 'description': 'CAT (COPD Assessment Test), symptom questionnaire, measured in points from 0- 40'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypercapnia', 'Physiotherapy', 'Inspiratory Muscle Training'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'The overall objective of the study is to investigate the feasibility of home based inspiratory muscle training (IMT) on chronic hypercapnia in patients with severe COPD, and to examine the relationship between inspiratory muscle strength and carbon dioxide level.', 'detailedDescription': 'The development of chronic hypercapnia in patients with COPD indicates an imbalance of increased ventilatory work caused by hyperinflation and airway resistance and a decreased inspiratory muscle reserve, probably caused by diaphragm- dysfunction. The inspiratory muscle strength can be trained by a devise, which provides a resistance to inspiration.\n\nThis study will be conducted as an a feasibility study and will examine whether inspiratory muscle training with a Power Breathe device (K3) is possible over a 6 week period in patients with COPD and chronic hypercapnia (pCO2 \\> 6 kilo pascal).\n\nIMT will be considered as feasible if 80% of the planned training sessions have been completed, and if the maximum inspiratory strength improves by an average of 10% from MIP and if patients do not experience any discomfort or increased dyspnea during training.\n\nThe training of the respiratory strength is carried out daily with an electronic handheld device (Power Breathe K3) and will consist of 2x30 inspirations per day with the resistance adjusted individually and progressively with a pressure of 30 - 50% of maximal inspiratory pressure. Training will take place in the home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have the diagnosis COPD with FEV1 / FVC \\<0.70 and FEV1 \\<50%\n* Have elevated pCO2 in stable phase assessed by arterial blood gas with pCO2\\> 6 kPa\n* Have given informed consent\n* Can understand written and oral instructions\n\nExclusion Criteria:\n\n* Patients are included in other projects with impact on the carbon dioxide level, e.g. home noninvasive ventilation treatment\n* Patients using variable oxygenation rate that may affect the carbon dioxide level.\n* Unstable patients and at high risk of exacerbation during the investigation period\n* Hospitalized patient with COPD exacerbation during the intervention period\n* Patients with an expected need for change of COPD medication or oxygen supply equipment in the study period.\n\nThe participation in the study will be postponed if the patient is in a rehabilitation program'}, 'identificationModule': {'nctId': 'NCT02914093', 'acronym': 'THYPISK-f', 'briefTitle': 'IMT in Hypercapnic Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Feasibility of Inspiratory Muscle Training in Patients With Chronic Hypercapnia and Severe Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'H-16022336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMT-feasibility', 'description': 'Single arm intervention', 'interventionNames': ['Other: IMT']}], 'interventions': [{'name': 'IMT', 'type': 'OTHER', 'description': 'Inspiratory muscle training for 6 weeks 2x30 breaths daily as a home based program', 'armGroupLabels': ['IMT-feasibility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital, Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Morten T Kristensen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Copenhagen University Hospital, Hvidovre'}, {'name': 'Ejvind F Hansen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pulmonary Sektion, Copenhagen University Hospital, Hvidovre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Linette Marie Kofod', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}