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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01743586
Enrollment
102
Registered
2012-12-06
Start date
2010-08-31
Completion date
2013-08-31
Last updated
2012-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

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

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.

Interventions

OTHERChest 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

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Numbers of upper respiratory infections (URI) and respiratory infection related hospitalizations12 months after study entryNumbers of URIs and respiratory infection related hospitalizations were collected from out-patient and inpatient medical records.

Secondary

MeasureTime frameDescription
Funcional capacity Anxiety/depression symptom Quality of life Six- and 12-month respiratory complication morbidity and survival statusevery 3 months up to 18 months post study entryFunctional capacity measures included six-minute walk test, 50-foot walk with preferred and fast speed, and Barthel Index
Dyspnea and QoLevery 3 months up to 18 monthsDyspnea was assessed using modified Borg scale and QoL was assessed using EORTC QLQ-C30 and LC13 questionnaires.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026