Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-01 @ 9:14 PM
Study NCT ID:
NCT04820257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based Pulmonary Rehabilitation for COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'starting with a small pilot and will follow with parallell design RCT - starting later'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease specific quality of life', 'timeFrame': '8-12 weeks', 'description': 'Chronic Respiratory Questionnaire (CRQ)'}, {'measure': 'Modified Medical Research Council Dyspnea scale (mMRC),', 'timeFrame': '8-12 weeks', 'description': 'Dyspnea'}, {'measure': 'COPD assessment Test (CAT)', 'timeFrame': '8-12 weeks', 'description': 'assess symptoms of breathing'}], 'secondaryOutcomes': [{'measure': 'GAD to asses anxiety and depression symptoms', 'timeFrame': '8-12 weeks', 'description': 'assessing anxiety and depression symptoms'}, {'measure': 'Online breathing and mindful movement exercises/ exercise routine', 'timeFrame': '8-12 weeks', 'description': 'Total time performing the breathing exercises'}, {'measure': 'Activity monitoring', 'timeFrame': '8-12 weeks', 'description': 'number of steps'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tele-health', 'behavioural change', 'motivational interviewing', 'home-based exercise', 'self-related health', 'quality of life'], 'conditions': ['COPD, Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Objectives The objective of this project is to motivate patients with COPD to incorporate the habit of doing daily mindful physical activity by using the proposed home-based pulmonary rehabilitation program that integrates video guided exercises, activity monitoring daily steps and health coaching. This program will allow patients to complete Pulmonary Rehabilitation (PR) at home and promote behavior change and lead to a more active lifestyle for patients with COPD who have been prescribed PR.\n\nThe program will be able to effectively monitor daily step count. A health coach will receive more this detailed data and will guide weekly health coaching sessions designed to increase awareness of the physical activities completed and ignite inner motivation for healthy behaviors.\n\nThe proposed PR program is innovative and responds to an unmet need in chronic care for COPD patients in the context of COVID-19 pandemic and it mitigates the common accessibility barriers.', 'detailedDescription': 'Specific aims will guide the proposed project:\n\n* Aim 1: To determine the feasibility of the proposed home-based PR program. We will additionally address adherence and appropriateness of the program.\n* Aim 2: To determine improvements in quality of life and mental health of the proposed home-based PR determined.\n* Aim 3: To evaluate if the average number of daily step counts increase after the home-based PR program'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women age 40 years and older\n* FEV1 \\<80% or less (forced expiratory volume in one second) as documented by pulmonary function.\n* Medical diagnosis of COPD, GOLD classification B,D, and C based on symptoms and history of exacerbations.\n* The patients must be able to access a smart-phone or computer tablet with internet service.\n\nExclusion Criteria:\n\n* Unable to perform low intensity exercise.\n* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move, are not living in the healthcare area.\n* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).'}, 'identificationModule': {'nctId': 'NCT04820257', 'briefTitle': 'Home-based Pulmonary Rehabilitation for COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Home-based Pulmonary Rehabilitation for COPD Patients', 'orgStudyIdInfo': {'id': '2021-01151:DNR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home based exercise', 'description': 'Home based exercise with health coaching', 'interventionNames': ['Behavioral: Home based exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care, waiting list'}], 'interventions': [{'name': 'Home based exercise', 'type': 'BEHAVIORAL', 'description': 'Exercise at home and behavioural change to increase daily exercise', 'armGroupLabels': ['Home based exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'contacts': [{'name': 'Marian Papp, PhD', 'role': 'CONTACT', 'email': 'marian.papp@ki.se', 'phone': '+46706946553'}], 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Marian Papp, PhD', 'role': 'CONTACT', 'email': 'marian.papp@ki.se', 'phone': '+46706946553'}], 'overallOfficials': [{'name': 'Marian Papp, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Marian Papp', 'investigatorAffiliation': 'Karolinska Institutet'}}}}