Effect of Pulmonary Rehabilitation in Lung Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT01246297|
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Lobectomy Pulmonary Rehabilitation||Other: Pulmonary Rehabilitation Other: Usual post operative care||Not Applicable|
The research question is to investigate
- whether patients who have undergone curative surgical resection for lung cancer benefit from 8 weeks of early outpatient pulmonary rehabilitation (started within 2 weeks of hospital discharge).
- to identify potential barriers to this approach
Pulmonary rehabilitation (PR) is the most effective non-pharmacological treatment for patients with chronic respiratory diseases, especially COPD. Many patients with lung cancer have co-existing smoking-related lung disorders such as COPD. To date there have been no randomised controlled trials of PR in post-resection lung cancer survivors. However there is indirect evidence that PR may be of benefit in this patient cohort. Cesario et al (2007)reported a 32% improvement in exercise capacity with in-patient PR, and Spruit et al (2009) demonstrated a 43% improvement in six minute walk distance following an 8-week in-patient PR programme. However, both studies had small numbers, and no randomised control group. Furthermore, inpatient PR is not an economically justifiable intervention in the NHS where emphasis is on self-management and ambulatory care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Pilot Study of Early Outpatient Pulmonary Rehabilitation Following Thoracic Surgery for Lung Cancer|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||November 2011|
Other: Usual post operative care
Usual post operative care for post lung lobectomy patients for 8 weeks post discharge.
Active Comparator: Pulmonary Rehabilitation
Pulmonary Rehabilitation consists of twice weekly exercise classes with an educational component.
Other: Pulmonary Rehabilitation
Twice weekly exercise classes with an education component. For 8 weeks.
- Six minute walk test to assess exercise tolerance [ Time Frame: Within 3 month of discharge from surgery ]
- Shoulder Range of Motion Changes [ Time Frame: Within 3 months of discharge from surgery ]
- Bioimpedence for tissue composition [ Time Frame: Within 3 months of discharge from surgery ]
- Quality of life measurement changes [ Time Frame: Within 3 months of discharge from surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246297
|Harefield, Middlesex, United Kingdom, UB9 6JH|
|Imperial College Healthcare Trust|
|London, United Kingdom, W21NY|
|Principal Investigator:||Sarah Elkin, FRCP||Imperial College Healthcare Trust|