Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-03-02 @ 4:12 AM
Study NCT ID:
NCT01452932
Status:
UNKNOWN
Last Update Posted:
2012-06-26
First Post:
2011-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-22', 'studyFirstSubmitDate': '2011-10-13', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea degree', 'timeFrame': 'Up to 12 weeks', 'description': 'The degree of dyspnea is measured at baseline as one of the most important criteria for inclusion, after randomization of participants and past twelve weeks (duration of the intervention protocol) is measured this variable as a primary outcome.'}, {'measure': 'Aerobic capacity', 'timeFrame': 'Up to 12 weeks', 'description': 'Aerobic capacity is measured with the six minutes walking test (6MWT) at baseline as one of the most important criteria for inclusion, performed after randomization of participants and past twelve weeks (duration of the intervention protocol) is measured this variable as a secondary outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease', 'Dyspnea', 'Exercise test', 'Endurance training'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Dyspnea']}, 'descriptionModule': {'briefSummary': 'Objective: To estimate the effectiveness of muscle training, the degree of dyspnea and aerobic capacity in patients over 50 with COPD, in a health care institution provider in Antioquia.\n\nQuestion: What is the effectiveness of muscle training, in the degree of dyspnea and aerobic capacity in COPD patients over 50 years, in a health service institution provider in the department of Antioquia?\n\nHypothesis: Muscle training causes changes in the degree of dyspnea and aerobic capacity, other than the breathing exercises and relaxation\n\nDesign: Randomized clinical trial with allocation and blinding of the autcomes assesor.\n\nParticipants: COPD patients stage II and II, male and female, over 50 years old, who are attending to a community health service provider in the department of Antioquia.\n\nIntervention: A physiotherapeutic intervention using PNF technique was applied to the experimental physiotherapy group versus Yoga sessions applied to the other group. Twelve weeks protocol performing three sessions per week.\n\nOutcome measures: Dyspnea degree and aerobic capacity was measured using the MMRC scale and the six minute walking test respectively at the begining and the end of the study.', 'detailedDescription': 'Chronic obstructive pulmonary disease (COPD) is defined by GOLD (The Global Initiative for Chronic Obstructive Lung Disease) as a disease process characterized by progressive airflow limitation associated with an abnormal inflammatory response of the lungs to particles or harmful gases and is not fully reversible. This restriction generates an expiratory flow of air entrapment resulting hyperinflation, coupled with the effects that systemic, structural changes occur in skeletal muscles which leads to greater fatigue causing dyspnea. Consequently, patients with COPD require participation of accessory muscles of respiration, which should have a dual function during activities involving the upper limbs, to supply the ventilatory requirements and movements of the shoulder girdle, which increases dyspnea carrying the patient to stop their activities, leading to physical deconditioning and progressively decreasing aerobic capacity. This demonstrates the need to improve the resistance of the upper limb muscles in these patients, thus contributing to a reduction in the degree of dyspnea and improved their aerobic capacity. The investigators propose a study aimed at determining the effectiveness of muscle training in the degree of dyspnea and aerobic capacity in COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women over 50 years with a diagnosis of COPD stage II and III according to GOLD classification, performed spirometry\n* Patients who manifest dyspnea on MRC\n* Patients SGSS affiliates.\n* COPD controlled, verified medical history\n* Voluntary participation in informed consent\n\nExclusion Criteria:\n\n* Higher mental functions altered\n* Degenerative musculoskeletal diseases (acute state)\n* Multisystem disease not controlled\n* Perform a current fitness program'}, 'identificationModule': {'nctId': 'NCT01452932', 'briefTitle': 'Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD', 'organization': {'class': 'OTHER', 'fullName': 'CES University'}, 'officialTitle': 'Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD in an Institution Health Service Provider in the Department of Antioquia', 'orgStudyIdInfo': {'id': 'UCESCOPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiotherapy', 'description': 'Group of participants who recive physiotherapy treatment using Kabat technique for the upper limbs resistance training during 12 weeks', 'interventionNames': ['Other: Physiotherapy']}, {'type': 'OTHER', 'label': 'Yoga', 'description': 'Group of participants who recive Yoga sessions during 12 weeks', 'interventionNames': ['Other: Yoga']}], 'interventions': [{'name': 'Physiotherapy', 'type': 'OTHER', 'description': 'The physiotherapeutic intervention was based on the Kabat (PNF) technique. Thirty-three sessions were planed. Each session lasted between thirty and fifty minutes.\n\nThe experimental group was guided by a physiotherapist or a physiotherapy student and each session took place in a hospital auditorium provided with oxygen cylinders, chairs and water.\n\nEach session consisted of a warm up and stretch period, a period of resistance training of the upper limbs with their rest periods in which diaphragmatic breathing exercises and finally a cooling period.\n\nThe instructions and instruments given to each participant such as weights and elastic bands were the same for all of them.', 'armGroupLabels': ['Physiotherapy']}, {'name': 'Yoga', 'type': 'OTHER', 'description': 'The intervention for the other group was the Yoga technique. Thirty-six sessions were planed. Each session was based on breathing, relaxation, and stretching exercises. Each session lasted between thirthy and forty minutes.\n\nThe group was led by a Yoga Instructor and each sessions took place in a hospital auditorium provided by oxygen cylinders, chairs and water.\n\nNo instruments were needed for this intervention.', 'armGroupLabels': ['Yoga']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nathalia Suarez, Profesional', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor CES University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CES University', 'class': 'OTHER'}, 'collaborators': [{'name': 'La ceja Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nathalia Suarez', 'investigatorAffiliation': 'CES University'}}}}