Trial record 6 of 356 for:    pulmonary rehabilitation

Effect of Pulmonary Rehabilitation in Lung Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Imperial College Healthcare NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Royal Brompton & Harefield NHS Foundation Trust
North West London Cancer Network
Information provided by:
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01246297
First received: November 22, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Lung Cancer
Lobectomy
Pulmonary Rehabilitation
Other: Pulmonary Rehabilitation
Other: Usual post operative care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Early Outpatient Pulmonary Rehabilitation Following Thoracic Surgery for Lung Cancer

Resource links provided by NLM:


Further study details as provided by Imperial College Healthcare NHS Trust:

Primary Outcome Measures:
  • Six minute walk test to assess exercise tolerance [ Time Frame: Within 3 month of discharge from surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Shoulder Range of Motion Changes [ Time Frame: Within 3 months of discharge from surgery ] [ Designated as safety issue: No ]
  • Bioimpedence for tissue composition [ Time Frame: Within 3 months of discharge from surgery ] [ Designated as safety issue: No ]
  • Quality of life measurement changes [ Time Frame: Within 3 months of discharge from surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Usual Care
Other: Usual post operative care
Usual post operative care for post lung lobectomy patients for 8 weeks post discharge.
Active Comparator: Pulmonary Rehabilitation
Pulmonary Rehabilitation consists of twice weekly exercise classes with an educational component.
Other: Pulmonary Rehabilitation
Twice weekly exercise classes with an education component. For 8 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246297

Contacts
Contact: Elizabeth Schofield, BExSc MPhty +442033122349 libby.schofield@imperial.nhs.uk

Locations
United Kingdom
Harefield Hospital Recruiting
Harefield, Middlesex, United Kingdom, UB9 6JH
Contact: William Man, BSc MBBS MRCP PhD    01895828851    w.man@rbht.nhs.uk   
Imperial College Healthcare Trust Recruiting
London, United Kingdom, W21NY
Contact: Elizabeth Schofield    02033122349    libby.schofield@imperial.nhs.uk   
Contact: Sarah Elkin, MCSP MD FRCP    02033127942    sarah.elkin@imperial.nhs.uk   
Principal Investigator: Elizabeth Schofield, B Ex Sc, MPhty         
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
North West London Cancer Network
Investigators
Principal Investigator: Sarah Elkin, FRCP Imperial College Healthcare Trust
  More Information

No publications provided

Responsible Party: Research Governance Manager, AHSC Joint Research Office, Imperial College London and Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01246297     History of Changes
Other Study ID Numbers: JROSM0090
Study First Received: November 22, 2010
Last Updated: November 22, 2010
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014