Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

NCT ID: NCT01246297

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer Lobectomy Pulmonary Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Usual Care

Group Type OTHER

Usual post operative care

Intervention Type OTHER

Usual post operative care for post lung lobectomy patients for 8 weeks post discharge.

Pulmonary Rehabilitation

Pulmonary Rehabilitation consists of twice weekly exercise classes with an educational component.

Group Type ACTIVE_COMPARATOR

Pulmonary Rehabilitation

Intervention Type OTHER

Twice weekly exercise classes with an education component. For 8 weeks.

Interventions

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Pulmonary Rehabilitation

Twice weekly exercise classes with an education component. For 8 weeks.

Intervention Type OTHER

Usual post operative care

Usual post operative care for post lung lobectomy patients for 8 weeks post discharge.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role collaborator

London Cancer Alliance (North West London Cancer Network)

UNKNOWN

Sponsor Role collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Elkin, FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare Trust

Locations

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Harefield Hospital

Harefield, Middlesex, United Kingdom

Site Status

Imperial College Healthcare Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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JROSM0090

Identifier Type: -

Identifier Source: org_study_id

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