Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT06869720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eecentric Exercise on Cardiopulmonary Fitness and Quality of Life with Chronic Obstructive Pulmonary Disease
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'six minute walk test', 'timeFrame': '12 weeks', 'description': 'functional performance'}, {'measure': 'time up and go', 'timeFrame': '12 weeks', 'description': 'functional performance'}, {'measure': 'stairs ascending and descending walking time', 'timeFrame': '12 weeks', 'description': 'functional performance'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary rehabilitation', 'Eccentric exercise', 'Chronic obstructive pulmonary disease', 'Cardiopulmonary fitness', 'Functional fitness'], 'conditions': ['COPD (Chronic Obstructive Pulmonary Disease)']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of elliptical exercise on the six-minute walk test and quality of life in patients with chronic obstructive pulmonary disease (COPD) to identify the most efficient exercise training method.', 'detailedDescription': 'Background： Chronic respiratory diseases, including COPD, are leading causes of chronic illness and mortality worldwide. However, limitations in ventilation and muscle function restrict COPD patients from engaging in higher-power exercise therapies. Compared to concentric exercise, eccentric exercise can effectively improve health-related fitness and quality of life at lower cardiopulmonary and metabolic loads. Pulmonary rehabilitation programs have been shown to effectively improve symptoms of chronic respiratory diseases, increase exercise capacity, enhance quality of life, delay disease progression, prevent and treat acute exacerbations, and reduce mortality. Therefore, it is hoped that a "safe and effective" eccentric exercise strategy can be designed for COPD patients to comprehensively improve their cardiopulmonary/muscle fitness and quality of life, thereby improving the course of their disease.\n\nStudy Design： This is a one-year, single-center, prospective randomized controlled trial. Methods： This study plans to enroll 60 participants who will be randomly assigned to control and experimental groups. The intervention will take place in the pulmonary rehabilitation room on the sixth floor of Fu Jen Hospital. Each group will undergo a functional fitness test and complete a quality of life questionnaire before and after 24 sessions (over 12 weeks) of exercise training.\n\nEffect： It is anticipated that after 24 sessions of elliptical exercise training, there will be an improvement in the functional fitness and in quality of life related to physical activity function.\n\nKey words： Pulmonary rehabilitation; eccentric exercise; chronic obstructive pulmonary disease; cardiopulmonary fitness; functional fitness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Having undergone pulmonary rehabilitation for more than 3 months\n* Sign the written informed consent form\n* FEV1/FVC \\< 0.70\n* Approval for exercise training granted by a specialist physician's assessment\n* Specialist physician's approval for exercise training\n\nExclusion Criteria:\n\n* Existing of tracheostomy\n* Those who use oxygen therapy or ventilator at home\n* Severe heart failure (NYHA III-IV)\n* Neuromuscular disease\n* Acute exacerbation within the past three months\n* Those who are unable to cooperate with the cardiopulmonary exercise test"}, 'identificationModule': {'nctId': 'NCT06869720', 'briefTitle': 'Eecentric Exercise on Cardiopulmonary Fitness and Quality of Life with Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'The Impact of Eecentric Exercise on Cardiopulmonary Fitness and Quality of Life in Patients with Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'FJUH113384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group: eccentric cycling exercise', 'description': 'Received eccentric cycling exercise', 'interventionNames': ['Device: Eccentric bike']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Undergoing conventional treatment', 'interventionNames': ['Other: conventional group']}], 'interventions': [{'name': 'Eccentric bike', 'type': 'DEVICE', 'description': 'Received eccentric cycling exercise', 'armGroupLabels': ['Intervention Group: eccentric cycling exercise']}, {'name': 'conventional group', 'type': 'OTHER', 'description': 'Received conventional treatment', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24352', 'city': 'New Taipei City', 'country': 'Taiwan', 'contacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'ck_qq@hotmail.com', 'phone': '+886-905-301-879'}], 'facility': 'Fu Jen Catholic University Hospital, Fu Jen Catholic University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'ck_qq@hotmail.com', 'phone': '+886905301879'}], 'overallOfficials': [{'name': 'Ke-Yun Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu Jen Catholic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ke-Yun, Chao', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}