"EXHALE" A Randomized Clinical Trial Comparing the Effects of a 12 Week Supervised Exercise Intervention Versus Usual Care for Advanced Stage Lung Cancer Patients.
Control - usual care The patients randomized to the control group received no training but
are offered the chance to participate in the supervised training after they have completed
their antineoplastic treatment, at least after twelve weeks. Patients in early 2nd line
treatment ("switch maintenance") will be offered training after 12 weeks, although they have
not completed chemotherapy.
Intervention The supervised training was carried out in groups of 12-16 patients and each
session had a duration of 1.5 hours, was administered twice weekly and was supervised by a
research physiotherapist. The training comprised warm up exercises, strength and fitness
training as well as stretching. Warm up exercises consisted of 10 minutes of light,
stationery cycling, adjusted to 60-90% of the patient's maximum HR. Strength training was
carried out using 6 machines (Technogym: Leg press, chest press, lateral machine, leg
extension, abdominal crunch, and lower back). The practical aim of strength training was to
complete 3 series of 5-8 sets, with 70-90% of 1RM. The exercises were specifically selected
to involve the largest possible number of muscle groups in the least number of exercises. To
ensure progression in strength training, each patient was instructed in carrying out the 1RM
test using each of the above-mentioned strength training machines once every second week,
after which their program would be adjusted. Cardiovascular training was carried out as
interval training on stationery bikes. Intensity was equivalent to 85-95% of each patient's
maximum HR and lasted approximately 10-15 minutes. After the training session, 5-10 minutes
were dedicated to stretching the large muscle groups in order to increase agility. Following
each training session, progressive relaxation of 15-20 minutes was performed.
Pre training screening Each Patient was screened by a clinical nurse specialist prior to
participating in each physical training session and before the physiological tests (35). If
one of the following criteria were met, the patient was prohibited from exercising/being
tested on that day: diastolic blood pressure <45 or >95, heart rate (HR) at rest >115/min,
temperature > 38 0C, respiratory rate at rest >30/min, infection requiring treatment, fresh
bleeding, total leucocyte count <1.0 109/L or platelets <50 109/L. Physical tests and HRQOL
evaluation were performed at baseline and after six weeks of training.
Statistical analysis Sample size The applied calculations are performed on 55 patients on
the basis of VO2peak; through six weeks of training 55 patients achieved an increase of 0.85
ml / kg / min in VO2peak (SD = 2,48). It is assumed that the control group in the current
study will have a reduction of 0.5 ml / kg / min for VO2peak (SD = 2.48). Assumptions for
calculation of patient numbers are as follows: Type 1 error 0.05, type 2 error 0.20, and
success level 1.35, SD 2.48. This leads to a total number of patients of 108 (54 in each
arm). This study expects a drop-out rate of 50% and therefore another 108 patients must be
included, which gives a sample size of 216 patients.
Data entry is carried out in the Open Clinica and analysis will be performed using the
computer program SAS. As regards the choice of the statistical tests applied to data in
which there will be no continuous differences, that will be analyzed by paired t-test or a
corresponding non-parametric test, as categorical data are analyzed using the Pearson χ2
tests. Other data (e.g., from questionnaires) are analyzed using logistic regression and chi
square or Mantel Haenzel test. Significance level is set at 0.05.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
The primary endpoint will be VO2 peak, as assessed with an aerobic capacity (VO2 peak) incremental C-PET on a cycle ergometer (Monark, ergomedic 839E).The C-PET is carried out by a physiotherapist who is blinded to the patient's study group allocation. The test consists of a warm-up phase 2-4 minutes of cycling at a submaximal load (10-50 watts). After the warm-up period the load increases after a short break (<2 minutes) by 5-10 watts every minute, until exhaustion or a possible symptom limitation (e.g. dizziness, sudden pain, vomiting sensation). Expired gases will be analyzed continuously by a metabolic breath-by-breath analysis and calculated as an average over 15 seconds using the Oxycon Pro, Jaeger measurement system. During the C-PET, oxyhemoglobin saturation and heart rate will be continuously monitored. After each test, maximum ventilation, respiratory exchange ratio (RER), possibly plateau in the increase in VO2, self-perceived exertion perception in the final seconds of the
baseline and after 12 weeks
Denmark: Ethics Committee