Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

Not Applicable

Completed

• Conditions: Lung Cancer; Lobectomy; Pulmonary Rehabilitation
• Interventions: Other: Pulmonary Rehabilitation; Other: Usual post operative care

• Registration Number: NCT01246297
• Lead Sponsor: Imperial College Healthcare NHS Trust

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Primary Completion: 2011-07
• Study Completion: 2011-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All patients undergoing lung cancer surgery with curative intent.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary Rehabilitation	Pulmonary Rehabilitation	Pulmonary Rehabilitation consists of twice weekly exercise classes with an educational component.
Control	Usual post operative care	Usual Care

Primary Outcome Measures

Name	Time	Method
Six minute walk test to assess exercise tolerance	Within 3 month of discharge from surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Harefield Hospital; 🇬🇧 Harefield, Middlesex, United Kingdom

Imperial College Healthcare Trust; 🇬🇧 London, United Kingdom