Respiratory Muscle Function Changes and Effects of Chest Physiotherapy Education Interventionin Advanced Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01743586
First received: March 16, 2010
Last updated: December 4, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention
Lung Cancer
Other: Chest physiotherapy education intervention

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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Functional capacity measures included six-minute walk test, 50-foot walk with preferred and fast speed, and Barthel Index

  • Dyspnea and QoL [ Time Frame: every 3 months up to 18 months ] [ Designated as safety issue: No ]
    Dyspnea was assessed using modified Borg scale and QoL was assessed using EORTC QLQ-C30 and LC13 questionnaires.


Estimated Enrollment: 102
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control 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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743586

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Li-Ying Wang, Ph.D. School and Graduate Institute of Physical Therapy, National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01743586     History of Changes
Other Study ID Numbers: 200912088R
Study First Received: March 16, 2010
Last Updated: December 4, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Lung cancer
Chest physiotherapy
Respiratory muscle strength
Dyspnea, Functional capacity
Quality of life

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014