Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

Lung Cancer Clinical Trial

Official title:

A Pilot Study of Early Outpatient Pulmonary Rehabilitation Following Thoracic Surgery for Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246297
• Other study ID #: JROSM0090
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2022
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lobectomy
• Lung Cancer
• Lung Neoplasms
• Pulmonary Rehabilitation

Intervention

Other:
• Pulmonary Rehabilitation
Twice weekly exercise classes with an education component. For 8 weeks.
• Usual post operative care
Usual post operative care for post lung lobectomy patients for 8 weeks post discharge.

Locations

Country	Name	City	State
United Kingdom	Harefield Hospital	Harefield	Middlesex
United Kingdom	Imperial College Healthcare Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust	London Cancer Alliance (North West London Cancer Network), Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six minute walk test to assess exercise tolerance		Within 3 month of discharge from surgery
Secondary	Shoulder Range of Motion Changes		Within 3 months of discharge from surgery
Secondary	Bioimpedence for tissue composition		Within 3 months of discharge from surgery
Secondary	Quality of life measurement changes		Within 3 months of discharge from surgery