Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-04-12 @ 12:46 AM
Study NCT ID:
NCT05315505
Status:
UNKNOWN
Last Update Posted:
2023-08-24
First Post:
2022-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Home-based Pulmonary Rehabilitation Program in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000073278', 'term': 'Self-Management'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome evaluation will be performed by a cardiopulmonary technician that has no information about the patient group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization will be performed after verifying the inclusion and exclusion criteria in the study and the informed, free and informed consent of the individuals. Randomization will be carried out by permuted blocks of 4 to guarantee the same number of participants in each group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance in meters covered over a time of 6 minutes 0', 'timeFrame': 'Baseline', 'description': 'Distance in meters covered over a time of 6 minutes 0 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.'}, {'measure': 'Distance in meters covered over a time of 6 minutes 1', 'timeFrame': '8 weeks', 'description': 'Distance in meters covered over a time of 6 minutes 1 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.'}, {'measure': 'Distance in meters covered over a time of 6 minutes 2', 'timeFrame': '7 months', 'description': 'Distance in meters covered over a time of 6 minutes 2 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.'}, {'measure': 'Distance in meters covered over a time of 6 minutes 3', 'timeFrame': '12 months', 'description': 'Distance in meters covered over a time of 6 minutes 3 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.'}], 'secondaryOutcomes': [{'measure': 'Dyspnoea 0', 'timeFrame': 'Baseline', 'description': 'modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea'}, {'measure': 'Dyspnoea 1', 'timeFrame': '8 weeks', 'description': 'modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea'}, {'measure': 'Dyspnoea 2', 'timeFrame': '7 months', 'description': 'modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea'}, {'measure': 'Dyspnoea 3', 'timeFrame': '12 months', 'description': 'modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea'}, {'measure': 'Health-Related Quality of Life 0', 'timeFrame': 'Baseline', 'description': 'European quality of life-5 dimensions (EQ5D)'}, {'measure': 'Health-Related Quality of Life 1', 'timeFrame': '8 weeks', 'description': 'European quality of life-5 dimensions (EQ5D)'}, {'measure': 'Health-Related Quality of Life 2', 'timeFrame': '7 months', 'description': 'European quality of life-5 dimensions (EQ5D)'}, {'measure': 'Health-Related Quality of Life 3', 'timeFrame': '12 months', 'description': 'European quality of life-5 dimensions (EQ5D)'}, {'measure': 'Number of emergency department visits due to COPD exacerbation 0', 'timeFrame': 'Baseline', 'description': 'Number of exacerbations (accessing to emergency department)'}, {'measure': 'Number of emergency department visits due to COPD exacerbation 1', 'timeFrame': '8 weeks', 'description': 'Number of exacerbations (accessing to emergency department)'}, {'measure': 'Number of emergency department visits due to COPD exacerbation 2', 'timeFrame': '7 months', 'description': 'Number of exacerbations (accessing to emergency department)'}, {'measure': 'Number of emergency department visits due to COPD exacerbation 3', 'timeFrame': '12 months', 'description': 'Number of exacerbations (accessing to emergency department)'}, {'measure': 'COPD symptom control 0', 'timeFrame': 'Baseline', 'description': 'COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control'}, {'measure': 'COPD symptom control 1', 'timeFrame': '8 weeks', 'description': 'COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control'}, {'measure': 'COPD symptom control 2', 'timeFrame': '7 months', 'description': 'COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control'}, {'measure': 'COPD symptom control 3', 'timeFrame': '12 months', 'description': 'COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control'}, {'measure': 'Anxiety and Depression 0', 'timeFrame': 'Baseline', 'description': 'Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \\>8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring'}, {'measure': 'Anxiety and Depression 1', 'timeFrame': '8 weeks', 'description': 'Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \\>8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring'}, {'measure': 'Anxiety and Depression 2', 'timeFrame': '7 months', 'description': 'Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \\>8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring'}, {'measure': 'Anxiety and Depression 3', 'timeFrame': '12 months', 'description': 'Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \\>8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring'}, {'measure': 'Physical activity 0', 'timeFrame': 'Baseline', 'description': 'Counting steps per day with the pedometer Yamax EX510'}, {'measure': 'Physical activity 1', 'timeFrame': '8 weeks', 'description': 'Counting steps per day with the pedometer Yamax EX510'}, {'measure': 'Physical activity 2', 'timeFrame': '7 months', 'description': 'Counting steps per day with the pedometer Yamax EX510'}, {'measure': 'Physical activity 3', 'timeFrame': '12 months', 'description': 'Counting steps per day with the pedometer Yamax EX510'}, {'measure': 'Functional capacity 0', 'timeFrame': 'Baseline', 'description': 'Number of times per minute an individual is able to stand up and sit down on a chair standardised for height'}, {'measure': 'Functional capacity 1', 'timeFrame': '8 weeks', 'description': 'Number of times per minute an individual is able to stand up and sit down on a chair standardised for height'}, {'measure': 'Functional capacity 2', 'timeFrame': '7 months', 'description': 'Number of times per minute an individual is able to stand up and sit down on a chair standardised for height'}, {'measure': 'Functional capacity 3', 'timeFrame': '12 months', 'description': 'Number of times per minute an individual is able to stand up and sit down on a chair standardised for height'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Pulmonary rehabilitation', 'Maintenance pulmonary rehabilitation'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Pulmonary Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '38773568', 'type': 'DERIVED', 'citation': 'Silva L, Maricoto T, Mota A, Lemos L, Santos M, Cunha H, Azevedo I, Berger-Estilita J, Costa P, Padilha JM. Effectiveness of a home-based pulmonary rehabilitation maintenance programme: the Rehab2Life study protocol. BMC Nurs. 2024 May 21;23(1):338. doi: 10.1186/s12912-024-01999-6.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to develop and test the effectiveness of a new home-based pulmonary rehabilitation program comprising two distinct phases, the first in which an 8-week respiratory rehabilitation program is carried out the second in which a maintenance pulmonary rehabilitation program is carried out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD diagnose with B or E characterization according to GOLD criteria;\n* Residence in the area covered by the institution where the study is carried out\n\nExclusion Criteria:\n\n* Frequency of a PR programme in the previous six months\n* COPD exacerbation for less than one week;\n* Presence of unstable comorbidities (List of predetermined diagnoses that constitute absolute exclusion criteria);\n* Presence of comorbidities that constitute relative exclusion criteria through a medical evaluation.\n* Score of the Clinical Frailty Scale 2.0 above six or above five in case of not having a responsible caregiver and living alone\n* SpO2 below 85% in the 6-minute walk test'}, 'identificationModule': {'nctId': 'NCT05315505', 'acronym': 'Rehab2life', 'briefTitle': 'Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Unidade Local de Saúde de Matosinhos, EPE'}, 'officialTitle': 'Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients', 'orgStudyIdInfo': {'id': '136/CES/JAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maintenance', 'description': 'Participants will undergo an initial home-based pulmonary rehabilitation program for eight weeks.\n\nAt the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care.\n\nThe maintenance arm will receive home visits for supervised physical exercise and progressively alternated with phone calls to motivation and feedback', 'interventionNames': ['Other: Maintenance programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'Participants will undergo an initial home-based pulmonary rehabilitation program for eight weeks.\n\nAt the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care.\n\nThe control group will have access to the usual follow.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Maintenance programme', 'type': 'OTHER', 'otherNames': ['Physical exercise', 'Behaviour change', 'Self-management'], 'description': 'Continuous educational support, exercise training, behaviour change intervention, and self-management.\n\nMaintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision', 'armGroupLabels': ['Maintenance']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'No maintenance programme, and the patient has the usual follow-up and medical appointments', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4450', 'city': 'Matosinhos Municipality', 'state': 'Porto District', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Liliana Silva, MSc', 'role': 'CONTACT', 'email': 'enf.lilianasilva@gmail.com', 'phone': '+351917556931'}, {'name': 'Liliana Silva, MSc', 'role': 'CONTACT', 'email': 'liliana.silva@ulsm.min-saude.pt'}], 'facility': 'Unidade Local de Saúde de Matosinhos', 'geoPoint': {'lat': 41.18207, 'lon': -8.68908}}], 'centralContacts': [{'name': 'Liliana Silva, MSc', 'role': 'CONTACT', 'email': 'enf.lilianasilva@gmail.com', 'phone': '+351917556931'}, {'name': 'Miguel Padilha, PhD', 'role': 'CONTACT', 'email': 'miguelpadilha@esenf.pt'}], 'overallOfficials': [{'name': 'Liliana Silva, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Matosinhos Local Health Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unidade Local de Saúde de Matosinhos, EPE', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN', 'investigatorFullName': 'Liliana Silva', 'investigatorAffiliation': 'Unidade Local de Saúde de Matosinhos, EPE'}}}}