Overview

This trial is active, not recruiting.

Condition lung cancer
Treatment chest physiotherapy education intervention
Sponsor National Taiwan University Hospital
Collaborator National Science Council, Taiwan
Start date August 2010
End date August 2013
Trial size 102 participants
Trial identifier NCT01743586, 200912088R

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
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

Primary Outcomes

Measure
Numbers of upper respiratory infections (URI) and respiratory infection related hospitalizations
time frame: 12 months after study entry

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title 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
Principal investigator Li-Ying Wang, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.