Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

NCT01246297 | Completed

• 1 other identifier: JROSM0090
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer; Lobectomy; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Six minute walk test to assess exercise tolerance

  Within 3 month of discharge from surgery

Secondary Outcomes (3)

• 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

Study Arms (2)

Control

OTHER

Usual Care

Other: Usual post operative care

Pulmonary Rehabilitation

ACTIVE COMPARATOR

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

Other: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation OTHER

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

Pulmonary Rehabilitation

Usual post operative care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing lung cancer surgery with curative intent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• London Cancer Alliance (North West London Cancer Network): collaborator

Study Sites (2)

Harefield Hospital

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

Imperial College Healthcare Trust

London, W21NY, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sarah Elkin, FRCP

  Imperial College Healthcare Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

GB (2)