Effect of Pulmonary Rehabilitation in Lung Cancer Survivors
Recruitment status was Recruiting
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Purpose
Patients who have surgery to cure lung cancer often have multiple problems at hospital discharge and later on. This includes poor exercise performance and quality of life, breathlessness, pain and tiredness. Currently there is little formal physical or psychological support for such patients. This pilot study aims to investigate whether outpatient pulmonary rehabilitation (an exercise training and education programme), started within 2 weeks of hospital discharge, can lead to improvements in exercise performance and quality of life in patients who have undergone lung cancer surgery. The study will also assess whether pulmonary rehabilitation is acceptable for patients and will analyze the safety profile. The hypothesis is that patients; discharged from hospital after undergoing lung cancer surgery, have improved exercise performance and quality of life following early outpatient pulmonary rehabilitation compared with usual care.
| Condition | Intervention |
|---|---|
|
Lung Cancer Lobectomy Pulmonary Rehabilitation |
Other: Pulmonary Rehabilitation Other: Usual post operative care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Early Outpatient Pulmonary Rehabilitation Following Thoracic Surgery for Lung Cancer |
- Six minute walk test to assess exercise tolerance [ Time Frame: Within 3 month of discharge from surgery ] [ Designated as safety issue: Yes ]
- Shoulder Range of Motion Changes [ Time Frame: Within 3 months of discharge from surgery ] [ Designated as safety issue: No ]
- Bioimpedence for tissue composition [ Time Frame: Within 3 months of discharge from surgery ] [ Designated as safety issue: No ]
- Quality of life measurement changes [ Time Frame: Within 3 months of discharge from surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Control
Usual Care
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients undergoing lung cancer surgery with curative intent.
Exclusion Criteria:
- Unstable cardiovascular disease Severe musculo-skeletal problems that would limit exercise training(neuromuscular disorders, severe joint arthritis of lower limbs) Severe peripheral vascular disease Unable to walk 10 metres unaided Patients unable to give informed consent Recent (within 3 months of completing treatment) or untreated pulmonary TB, Untreated/uncontrolled diabetes or epilepsy Recent or recurrent untreated spontaneous pneumothorax
Contacts and Locations| Contact: Elizabeth Schofield, BExSc MPhty | +442033122349 | libby.schofield@imperial.nhs.uk |
| United Kingdom | |
| Harefield Hospital | Recruiting |
| Harefield, Middlesex, United Kingdom, UB9 6JH | |
| Contact: William Man, BSc MBBS MRCP PhD 01895828851 w.man@rbht.nhs.uk | |
| Imperial College Healthcare Trust | Recruiting |
| London, United Kingdom, W21NY | |
| Contact: Elizabeth Schofield 02033122349 libby.schofield@imperial.nhs.uk | |
| Contact: Sarah Elkin, MCSP MD FRCP 02033127942 sarah.elkin@imperial.nhs.uk | |
| Principal Investigator: Elizabeth Schofield, B Ex Sc, MPhty | |
| Principal Investigator: | Sarah Elkin, FRCP | Imperial College Healthcare Trust |
More Information
No publications provided
| Responsible Party: | Research Governance Manager, AHSC Joint Research Office, Imperial College London and Imperial College Healthcare NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01246297 History of Changes |
| Other Study ID Numbers: | JROSM0090 |
| Study First Received: | November 22, 2010 |
| Last Updated: | November 22, 2010 |
| Health Authority: | United Kingdom: National Health Service |
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 May 16, 2013