Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-26 @ 7:38 PM
Study NCT ID:
NCT06142266
Status:
UNKNOWN
Last Update Posted:
2023-11-21
First Post:
2023-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Status in COPD Patients After Exercise Rehabilitation Program
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': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be randomly allocated to either the intervention or control group in a 1:1 ratio using computer-generated randomization'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial conducted at Chest Department at Assiut University Hospital'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2023-11-16', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in exercise capacity', 'timeFrame': 'baseline', 'description': 'Asess by Change in 6-minute walk distant'}], 'secondaryOutcomes': [{'measure': 'Health related quilt of life', 'timeFrame': 'baseline', 'description': 'Asess by St .George Questioner'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Copd']}, 'referencesModule': {'references': [{'pmid': '29526182', 'type': 'BACKGROUND', 'citation': 'Gloeckl R, Schneeberger T, Jarosch I, Kenn K. Pulmonary Rehabilitation and Exercise Training in Chronic Obstructive Pulmonary Disease. Dtsch Arztebl Int. 2018 Feb 23;115(8):117-123. doi: 10.3238/arztebl.2018.0117.'}, {'pmid': '32021150', 'type': 'BACKGROUND', 'citation': 'Rutkowski S, Rutkowska A, Kiper P, Jastrzebski D, Racheniuk H, Turolla A, Szczegielniak J, Casaburi R. Virtual Reality Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Jan 13;15:117-124. doi: 10.2147/COPD.S223592. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of the exercise program in improving physical fitness and exercise capacity in COPD patients like walking distance, muscle strength, endurance will be measured before and after the program.\n\nTo assess whether the program helps reduce COPD symptoms like shortness of breath and fatigue during daily activities. Quality of life questionnaires will be used.', 'detailedDescription': "Pulmonary rehabilitation is a comprehensive, multidisciplinary program that utilizes exercise training and patient education to improve the physical and psychological condition of people living with chronic respiratory diseases Exercise therapy and education work in an integrated manner to help patients better manage their condition.\n\nExercise therapy is a core component of pulmonary rehabilitation. Regular physical activity helps build endurance, strengthen respiratory muscles, and improve overall functional capacity . Both aerobic and resistance exercises are prescribed according to individual abilities and needs .Studies have shown exercise training can reduce symptoms, increase quality of life, and decrease healthcare utilization among pulmonary patients .Patient education teaches self-management skills like breathing techniques, medication management, coping strategies, and how to prevent or deal with exacerbations . Educating patients empowers them to better understand their condition and play an active role in their care. It also helps address anxiety and depression that often accompany chronic lung disease .\n\nRecent reviews continue to support the benefits of pulmonary rehabilitation's holistic, exercise-education approach meta-analysis found multidisciplinary programs significantly improved outcomes such as hospital admissions compared to usual care . Additionally, study showed telerehabilitation with remote exercise monitoring and video classes achieved comparable benefits to traditional center-based programs . In summary, exercise therapy and education are core components of effective pulmonary rehabilitation"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of moderate-severe chronic obstructive pulmonary disease (COPD) based on spirometry results and clinical assessment.\n* Age between 40 and 75 years. Stable disease status, defined as no exacerbations requiring admission to respiratory intensive care unit\n* Willingness and ability to participate in a 12-week pulmonary rehabilitation program.\n\nExclusion Criteria:\n\n* Presence of significant comorbidities or medical conditions that may interfere with participation in the pulmonary rehabilitation program (e.g., severe cardiovascular disease, musculoskeletal disorders, uncontrolled hypertension).\n* Inability to perform the required exercise activities due to physical limitations or disabilities.\n\nCognitive impairment'}, 'identificationModule': {'nctId': 'NCT06142266', 'briefTitle': 'Functional Status in COPD Patients After Exercise Rehabilitation Program', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Improvement in Functional Status in Moderate to Severe Stable COPD Patients After Exercise Rehabilitation Program', 'orgStudyIdInfo': {'id': 'COPD&Exercise rehabilitation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'The intervention group (n=60) will undergo a 12-week pulmonary rehabilitation program. This program will consist of twice-weekly supervised exercise sessions, including aerobic training and resistance exercises targeting the lower limbs.', 'interventionNames': ['Other: Exercise rehabilitation program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The control group (n=60) will receive usual medical care according to guidelines, which may include bronchodilator/anti-inflammatory therapy but no formal pulmonary rehabilitation.', 'interventionNames': ['Other: Exercise rehabilitation program']}], 'interventions': [{'name': 'Exercise rehabilitation program', 'type': 'OTHER', 'description': 'This program will consist of twice-weekly supervised exercise sessions, including aerobic training and resistance exercises targeting the lower limbs for 12-week', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hend saleh, MD', 'role': 'CONTACT', 'email': 'hend.m.saleh@gmail.com', 'phone': '01098988712'}, {'name': 'Aliae Hussein, professor', 'role': 'CONTACT', 'email': 'Aliaehussein@aun.edu.eg', 'phone': '01222302352'}], 'overallOfficials': [{'name': 'Heba fahmy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecture of chest diseases', 'investigatorFullName': 'Hend Mohamed Sayed Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}