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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


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Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

12 months after study entry

Safety Issue:

No

Principal Investigator

Li-Ying Wang, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

School and Graduate Institute of Physical Therapy, National Taiwan University

Authority:

Taiwan: Department of Health

Study ID:

200912088R

NCT ID:

NCT01743586

Start Date:

August 2010

Completion Date:

August 2013

Related Keywords:

  • Lung Cancer
  • Lung cancer
  • Chest physiotherapy
  • Respiratory muscle strength
  • Dyspnea, Functional capacity
  • Quality of life
  • Lung Neoplasms

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