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CompletedNCT01246297Updated Mar 17, 2022

Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

An interventional study of Pulmonary Rehabilitation and Usual post operative care in Lung Cancer, Lobectomy and Pulmonary Rehabilitation, sponsored by Imperial College Healthcare NHS Trust. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by Imperial College Healthcare NHS Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer
  • Lobectomy
  • Pulmonary Rehabilitation

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Imperial College Healthcare NHS Trust is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients undergoing lung cancer surgery with curative intent.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Other
    Control

    Usual Care

    Other: Usual post operative care

  • Active comparator
    Pulmonary Rehabilitation

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

    Other: Pulmonary Rehabilitation

Interventions

  • OtherPulmonary Rehabilitation

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

  • OtherUsual post operative care

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

06

What researchers measure

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

07

Study locations

2 sites
  • Harefield Hospital
    Harefield, Middlesex UB9 6JH, United Kingdom
  • Imperial College Healthcare Trust
    London, W21NY, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01246297
Lead sponsor
Imperial College Healthcare NHS Trust
Collaborators
Royal Brompton & Harefield NHS Foundation Trust, London Cancer Alliance (North West London Cancer Network)
Responsible party
Sponsor
First posted
Nov 23, 2010
Start date
Oct 2010
Primary completion
Jul 2011
Completion
Nov 2011
Last update
Mar 17, 2022

Study contacts

Sarah Elkin, FRCP
principal investigator · Imperial College Healthcare Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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