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Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

Primary Purpose

Lung Cancer, Lobectomy, Pulmonary Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Usual post operative care
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harefield Hospital
  • Imperial College Healthcare Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control

Pulmonary Rehabilitation

Arm Description

Usual Care

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

Outcomes

Primary Outcome Measures

Six minute walk test to assess exercise tolerance

Secondary Outcome Measures

Shoulder Range of Motion Changes
Bioimpedence for tissue composition
Quality of life measurement changes

Full Information

First Posted
November 22, 2010
Last Updated
March 16, 2022
Sponsor
Imperial College Healthcare NHS Trust
Collaborators
Royal Brompton & Harefield NHS Foundation Trust, London Cancer Alliance (North West London Cancer Network)
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1. Study Identification

Unique Protocol Identification Number
NCT01246297
Brief Title
Effect of Pulmonary Rehabilitation in Lung Cancer Survivors
Official Title
A Pilot Study of Early Outpatient Pulmonary Rehabilitation Following Thoracic Surgery for Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust
Collaborators
Royal Brompton & Harefield NHS Foundation Trust, London Cancer Alliance (North West London Cancer Network)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lobectomy, Pulmonary Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Usual Care
Arm Title
Pulmonary Rehabilitation
Arm Type
Active Comparator
Arm Description
Pulmonary Rehabilitation consists of twice weekly exercise classes with an educational component.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Twice weekly exercise classes with an education component. For 8 weeks.
Intervention Type
Other
Intervention Name(s)
Usual post operative care
Intervention Description
Usual post operative care for post lung lobectomy patients for 8 weeks post discharge.
Primary Outcome Measure Information:
Title
Six minute walk test to assess exercise tolerance
Time Frame
Within 3 month of discharge from surgery
Secondary Outcome Measure Information:
Title
Shoulder Range of Motion Changes
Time Frame
Within 3 months of discharge from surgery
Title
Bioimpedence for tissue composition
Time Frame
Within 3 months of discharge from surgery
Title
Quality of life measurement changes
Time Frame
Within 3 months of discharge from surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Elkin, FRCP
Organizational Affiliation
Imperial College Healthcare Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harefield Hospital
City
Harefield
State/Province
Middlesex
ZIP/Postal Code
UB9 6JH
Country
United Kingdom
Facility Name
Imperial College Healthcare Trust
City
London
ZIP/Postal Code
W21NY
Country
United Kingdom

12. IPD Sharing Statement

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Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

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