Exercise in Advanced Stage Lung Cancer Patients

Small Cell Lung Cancer Clinical Trial

— EXHALE  

Official title:

"EXHALE" A Randomized Clinical Trial Comparing the Effects of a 12 Week Supervised Exercise Intervention Versus Usual Care for Advanced Stage Lung Cancer Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881906
• Other study ID #: fdaaa
• Secondary ID: HA-2008-06
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: April 12, 2017

Study information

• Verified date: September 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of twelve weeks of a physical and psycho-social program consisting of: supervised, structured exercise training in a group of advanced lung cancer patients (cardio and strength training, relaxation training) twice weekly. Primary outcome is (VO2peak). The hypotheses are that patients who undergo this intervention will increase maximal oxygen uptake (VO2peak), strength (1RM), functional capacity (6MWD) and quality of life (HRQOL) and reduce the level of anxiety and depression compared to those who do not.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: April 12, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non small cell lung cancer stage IIIb-IV

• Small cell lung cancer Extensiv disease

• Patients >18 years

• WHO performance status 0-2

• undergoing chemotherapy

Exclusion Criteria:

• brain or bone metastases;

• prolonged bone marrow suppression

• anti-coagulant treatment

• symptomatic heart disease

• congestive heart failure

• arrhythmia

• myocardial infarction diagnosed within the last three months

• inability to provide informed consent.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer Stage
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Other:
• Usual care

• Exercise

Locations

Country	Name	City	State
Denmark	University Hospital of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient reported outcome	general wellbeing MOS SF-36 quality of life EORTC QLG C-30 + LC13 FACT instrument,general part (FACT-G) and the lung specific part (FACT-L) Pittsburgh Sleep Quality Index anxiety and depression HADS Additional questionnaires will assess self-reported physical activity, labour market attachment, work ability and social reintegration. Demographic data is collected from self-developed questionnaires and training diaries.	baseline - 12 weeks
Primary	VO2peak	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
Secondary	Muscle strength 1RM	Muscle strength is measured by the one repetition maximum (1RM)test using a Technogym that includes a leg press (lower extremity), chest press (pectoral muscles), lateral machine (latissimus dorsi), leg extension (quadriceps femoris), abdominal crunch (rectus abdominis) and lower back press (erector spinae).	baseline - 12 weeks
Secondary	Functional capacity 6 Minute walk distance (6MWD) test	Functional capacity is measured by a 6 MWD test. The test is carried out over a pre-measured distance of 28 meters, in compliance with the American Thoracic Society (ATS) statement	baseline- 12 weeks
Secondary	Forced Expiratory Volume in 1 second (FEV1)	Forced Expiratory Volume in 1 second (FEV1) is measured using a standard spirometry in a standing position with the use of the Oxycon Pro, Jaeger measurement system.	baseline - 12 weeks