Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-28 @ 3:32 AM
Study NCT ID:
NCT06085261
Status:
UNKNOWN
Last Update Posted:
2023-10-16
First Post:
2023-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COPD: A Multi-center Supervised Tele-rehabilitation Study
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-10-13', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-minute walk distance (6MWD)', 'timeFrame': '8 weeks; 20 weeks', 'description': '6-minute walk distance'}], 'secondaryOutcomes': [{'measure': 'pulmonary function', 'timeFrame': '8 weeks; 20 weeks', 'description': 'forced expiratory volume in 1 second (FEV1) \\[velocity\\]'}, {'measure': 'pulmonary function', 'timeFrame': '8 weeks; 20 weeks', 'description': 'ratio between FEV1 and forced vital capacity (FEV1/FVC) \\[velocity\\]'}, {'measure': 'pulmonary function', 'timeFrame': '8 weeks; 20 weeks', 'description': 'forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75%) \\[velocity\\]'}, {'measure': 'pulmonary function', 'timeFrame': '8 weeks; 20 weeks', 'description': 'inspiratory capacity (IC) \\[velocity\\]'}, {'measure': 'pulmonary function', 'timeFrame': '8 weeks; 20 weeks', 'description': 'residual volume (RV) \\[velocity\\]'}, {'measure': 'pulmonary function', 'timeFrame': '8 weeks; 20 weeks', 'description': 'total lung capacity (TLC) \\[velocity\\]'}, {'measure': 'pulmonary function', 'timeFrame': '8 weeks; 20 weeks', 'description': 'diffusing capacity of the lung for carbon monoxide (DLCO) \\[velocity\\]'}, {'measure': 'Respiratory muscle strength', 'timeFrame': '8 weeks; 20 weeks', 'description': 'maximum inspiratory pressure(MIP), maximum expiratory pressure(MEP)'}, {'measure': 'Short Physical Performance Battery(SPPB)', 'timeFrame': '8 weeks; 20 weeks', 'description': 'Test for health-related physical performance'}, {'measure': 'modified British medical research council(mMRC)', 'timeFrame': '8 weeks; 20 weeks', 'description': 'It is a self-reported symptom questionnaire ranging from 0-4 score, higher scores mean a worse outcome.'}, {'measure': 'COPD assessment test(CAT)', 'timeFrame': '8 weeks; 20 weeks', 'description': 'It is a self-reported quality of life questionnaire ranging from 0-10 score, higher scores mean a worse outcome.'}, {'measure': "St. George's Respiratory Questionnaire (SGRQ)", 'timeFrame': '8 weeks; 20 weeks', 'description': 'It is a self-reported symptom questionnaire ranging from 0-100 score, higher scores mean a worse outcome.'}, {'measure': 'Hospital Anxiety and Depression Scale(HADS)', 'timeFrame': '8 weeks; 20 weeks', 'description': 'It is a self-reported psychological status questionnaire ranging from 0-42 score, higher scores mean a worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'pulmonary rehabilitation', 'tele-rehabilitation'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease(COPD) patients could benefit from pulmonary rehabilitation(PR) in better managing of the disease and its symptoms and in avoiding future relapses and hospitalizations. However, due to a large number of drop outs from PR, lack of professionals, and the (Corona Virus Disease 2019) COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. The study aims to investigate the effects of a home-based PR program using minimal accessories, facilitated with wearable activity trackers and smartphones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Participants with a clinical diagnosis of and meeting the following criteria are eligible:\n\n1. Diagnosis of COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV and without acute exacerbation within the last 2 weeks.\n2. Motivated for participating in the project (and acceptance of randomization)\n3. Sufficient mobility to attend PR\n\nExclusion Criteria:\n\n1. Certain comorbidities (e.g. unstable coronary complications)\n2. Severe cognitive disabilities (e.g. dementia)\n3. Inability to cope with the program because of severe hearing or visual disorder.'}, 'identificationModule': {'nctId': 'NCT06085261', 'acronym': 'COPDMUST', 'briefTitle': 'COPD: A Multi-center Supervised Tele-rehabilitation Study', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Chronic Obstructive Pulmonary Disease: A Multi-center Supervised Tele-rehabilitation Study', 'orgStudyIdInfo': {'id': '2021-I2M-1-409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'home-based telerehabilitation', 'description': 'Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises.', 'interventionNames': ['Behavioral: home-based telerehabilitation group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'center-based traditional rehabilitation', 'description': 'Participants will undertake an aerobic, strength and respiratory training program of similar intensity and duration to the home-based program, at their site of recruitment.', 'interventionNames': ['Behavioral: center-based traditional rehabilitation group']}], 'interventions': [{'name': 'home-based telerehabilitation group', 'type': 'BEHAVIORAL', 'description': "Participants will download the web application in their smartphones in the hospital's outpatient clinic and learn to use the sports wristwatch. Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises. The initial aerobic exercise prescription for walking will be set at 80% of the speed walked during a 6-minute walk test (6MWT) and progressed each 4-week according to patient assessments. Resistance training for the arms and legs will utilize elastic bands, while respiratory training will utilize portable breathing trainer. During each training session, participants will be asked to follow the videos in the web application, wearing the sports wristwatch recording their exercise intensity. At the end of every training session, training data could be uploaded to the web platform automatically, which will be checked by staff in hospital.", 'armGroupLabels': ['home-based telerehabilitation']}, {'name': 'center-based traditional rehabilitation group', 'type': 'BEHAVIORAL', 'description': 'Participants will undertake an aerobic, strength and respiratory training program of similar intensity and duration to the home-based program, at their site of recruitment.\n\nThe initial aerobic exercise prescription for cycling will be set at 60% of the peak oxygen uptake (VO2) on a cardiopulmonary exercise test (CPET). Resistance training and respiratory training are similar to the telerehabilitation group.', 'armGroupLabels': ['center-based traditional rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Shiwei Qumu', 'role': 'CONTACT'}], 'facility': 'China-Japan Friendship hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ting Yang, MD', 'role': 'CONTACT', 'email': 'zryyyangting@163.com', 'phone': '84206272'}], 'overallOfficials': [{'name': 'Shiwei Qumu, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Ting YANG', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}