NCT01743586

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 6, 2012

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

March 16, 2010

Last Update Submit

December 4, 2012

Conditions

Keywords

Lung cancerChest physiotherapyRespiratory muscle strengthDyspnea, Functional capacityQuality of life

Outcome Measures

Primary Outcomes (1)

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

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

    12 months after study entry

Secondary Outcomes (2)

  • 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 Arms (1)

Control

NO INTERVENTION
Other: Chest physiotherapy education intervention

Interventions

breathing exercise (diaphragmatic breathing and pursed-lip breathing cough training secretion mobilization (percussion and vibration) progressive muscle relaxation pacing and energy-saving techniques

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Lung NeoplasmsDyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Li-Ying Wang, Ph.D.

    School and Graduate Institute of Physical Therapy, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2010

First Posted

December 6, 2012

Study Start

August 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 6, 2012

Record last verified: 2012-11

Locations