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Open Access Highly Accessed Study protocol

“EXHALE”: exercise as a strategy for rehabilitation in advanced stage lung cancer patients: a randomized clinical trial comparing the effects of 12 weeks supervised exercise intervention versus usual care for advanced stage lung cancer patients

Morten Quist12*, Seppo W Langer23, Mikael Rørth23, Karl Bang Christensen24 and Lis Adamsen125

Author Affiliations

1 The University Hospitals Centre for Health Research (UCSF), Copenhagen, Denmark

2 Centre for Integrated Rehabilitation of Cancer Patients (CIRE), Copenhagen, Denmark

3 Department of Oncology, Copenhagen University Hospital Rigshospitalet, 5073 Copenhagen, Denmark

4 Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark

5 Institute of Public Health, University of Copenhagen, Copenhagen, Denmark

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BMC Cancer 2013, 13:477  doi:10.1186/1471-2407-13-477

Published: 14 October 2013

Abstract

Background

Lung cancer is the leading cause of cancer death in North America and Western Europe. Patients with lung cancer in general have reduced physical capacity, functional capacity, poor quality of life and increased levels of anxiety and depression. Intervention studies indicate that physical training can address these issues. However, there is a lack of decisive evidence regarding the effect of physical exercise in patients with advanced lung cancer. The aim of this study is to evaluate the effects of a twelve weeks, twice weekly program consisting of: supervised, structured training in a group of advanced lung cancer patients (cardiovascular and strength training, relaxation).

Methods/Design

A randomized controlled trial will test the effects of the exercise intervention in 216 patients with advanced lung cancer (non-small cell lung cancer (NSCLC) stage IIIb - IV and small cell lung cancer (SCLC) extensive disease (ED)). Primary outcome is maximal oxygen uptake (VO2peak). Secondary outcomes are muscle strength (1RM), functional capacity (6MWD), lung capacity (Fev1) and patient reported outcome (including anxiety, depression (HADS) and quality of life (HRQOL)).

Discussion

The present randomized controlled study will provide data on the effectiveness of a supervised exercise intervention in patients receiving systemic therapy for advanced lung cancer. It is hoped that the intervention can improve physical capacity and functional level, during rehabilitation of cancer patients with complex symptom burden and help them to maintain independent function for as long as possible.

Trial registration

http://ClinicalTrials.gov, NCT01881906 webcite

Keywords:
Maximal oxygen uptake (VO2peak); Functional capacity; Exercise; Quality of life; Anxiety; Depression; Advanced lung cancer; Chemotherapy