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Clinical Trials/NCT01743586
NCT01743586
Unknown
Not Applicable

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

National Taiwan University Hospital1 site in 1 country102 target enrollmentAugust 2010
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
National Taiwan University Hospital
Enrollment
102
Locations
1
Primary Endpoint
Numbers of upper respiratory infections (URI) and respiratory infection related hospitalizations
Last Updated
13 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
August 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of stage III/V lung cancer
  • Normal cognition (a Mini Mental State Examination score of more than/equal to 24 points)
  • Able to finish all tests

Exclusion Criteria

  • A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. musculoskeletal disorders)
  • Unable to perform acceptable-quality spirometry

Outcomes

Primary Outcomes

Numbers of upper respiratory infections (URI) and respiratory infection related hospitalizations

Time Frame: 12 months after study entry

Numbers of URIs and respiratory infection related hospitalizations were collected from out-patient and inpatient medical records.

Secondary Outcomes

  • Funcional capacity Anxiety/depression symptom Quality of life Six- and 12-month respiratory complication morbidity and survival status(every 3 months up to 18 months post study entry)
  • Dyspnea and QoL(every 3 months up to 18 months)

Study Sites (1)

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