Clinical trial NCT01246297: Effect of Pulmonary Rehabilitation in Lung Cancer Survivors
Official title: A Pilot Study of Early Outpatient Pulmonary Rehabilitation Following Thoracic Surgery for Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lobectomy
Pulmonary Rehabilitation
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
name: London Cancer Alliance (North West London Cancer Network)
First posted: 2010-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Six minute walk test to assess exercise tolerance
timeFrame: Within 3 month of discharge from surgery
Secondary outcomes:
measure: Shoulder Range of Motion Changes
timeFrame: Within 3 months of discharge from surgery
measure: Bioimpedence for tissue composition
timeFrame: Within 3 months of discharge from surgery
measure: Quality of life measurement changes
timeFrame: Within 3 months of discharge from surgery
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Harefield Hospital
state: Middlesex
city: London
country: United Kingdom
facility: Imperial College Healthcare Trust
Study officials:
affiliation: Imperial College Healthcare Trust
name: Sarah Elkin, FRCP
role: PRINCIPAL_INVESTIGATOR
References: