Respiratory Muscle Function Changes and Effects of Chest Physiotherapy Education Interventionin Advanced Lung Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | March 16, 2010 | ||||
| Last Updated Date | December 4, 2012 | ||||
| Start Date ICMJE | August 2010 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Numbers of upper respiratory infections (URI) and respiratory infection related hospitalizations [ Time Frame: 12 months after study entry ] [ Designated as safety issue: No ] Numbers of URIs and respiratory infection related hospitalizations were collected from out-patient and inpatient medical records. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01743586 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Respiratory Muscle Function Changes and Effects of Chest Physiotherapy Education Interventionin Advanced Lung Cancer | ||||
| Official Title ICMJE | The Impact of Changes in Respiratory Muscle Function on Dyspnea, Functional Capacity, and Quality of Life in Patients With Advanced Lung Cancer & the Effects of Chest Physiotherapy Education Intervention | ||||
| Brief Summary | The purpose for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). The 2nd phase of this study will investigate the potential beneficial effects of chest physiotherapy in the same patient population (intervention group). |
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| Detailed Description | Respiratory muscle function is critical for maintaining effective alveolar ventilation, and airway secretions clearance. The reduction in respiratory muscle function might lead to chronic respiratory insufficiency, and potentially to life-threatening problems. Respiratory muscle function and the impacts of various treatments regimens have not been investigated longitudinally in patients with advanced lung cancer patients. The purposes for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). The 2nd phase of this study will investigate the potential beneficial effects of chest physiotherapy in the same patient population (intervention group). Methods: 102 patients with advanced lung cancer per group will be recruited from the National Taiwan University Hospital. Demographic and clinical signs/syndromes will be obtained from the chart. Pain and dyspnea will be measured using visual analog scale. Respiratory muscle strength will be tested by measuring maximal inspiratory and expiratory pressure (PImax and PEmax, respectively). Spirometric variables, forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) will be measured. Functional capacity will be measured using Karnofsky performance status and Simmonds functional assessment. Anxiety/depression symptom will be measured using Hospital Anxiety and Depression Scale. Quality of life will be measured using European Organization for Research and Treatment of Cancer, EORTC QLQ-C30 and LC13 questionnaire. Six- and 12-month respiratory complication morbidity and survival status will be recorded in the prospective nature. Clinical relevance: The prevalence of lung cancer is increasing in the recent years. To understand the indications for chest physiotherapy (e.g., respiratory muscle weakness and its related sequels) and the effects of chest physiotherapy program will shed light on if routine chest physiotherapy should be implanted for patients with advanced lung cancer during treatment. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE | Other: Chest physiotherapy education intervention
breathing exercise (diaphragmatic breathing and pursed-lip breathing cough training secretion mobilization (percussion and vibration) progressive muscle relaxation pacing and energy-saving techniques |
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| Study Arm (s) | No Intervention: Control
Intervention: Other: Chest physiotherapy education intervention |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 102 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01743586 | ||||
| Other Study ID Numbers ICMJE | 200912088R | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | National Taiwan University Hospital | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | National Science Council, Taiwan | ||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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