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Completed

NCT Number: NCT01246297

Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harefield Hospital, Harefield, Middlesex, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Rehabilitation

Other

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

Usual Post Operative Care

Other

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

Primary outcomes

  1. Six minute walk test to assess exercise tolerance

    Time frame: Within 3 month of discharge from surgery

Secondary outcomes

  1. Shoulder Range of Motion Changes

    Time frame: Within 3 months of discharge from surgery

  2. Bioimpedence for tissue composition

    Time frame: Within 3 months of discharge from surgery

  3. Quality of life measurement changes

    Time frame: Within 3 months of discharge from surgery

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Collaborators

  • London Cancer Alliance (North West London Cancer Network)
  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 23, 2010
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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