Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Pulmonary Rehabilitation; Lobectomy
• Intervention / Treatment: Other: Usual post operative care; Other: Pulmonary Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W21NY
    • Imperial College Healthcare Trust
  • Middlesex
    • Harefield, Middlesex, United Kingdom, UB9 6JH
      • Harefield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Six minute walk test to assess exercise tolerance	Within 3 month of discharge from surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Shoulder Range of Motion Changes	Within 3 months of discharge from surgery
Bioimpedence for tissue composition	Within 3 months of discharge from surgery
Quality of life measurement changes	Within 3 months of discharge from surgery

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Collaborators: Royal Brompton & Harefield NHS Foundation Trust; London Cancer Alliance (North West London Cancer Network)
• Investigators: Principal Investigator: Sarah Elkin, FRCP, Imperial College Healthcare Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 23, 2010

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: JROSM0090