Exercise in Advanced Stage Lung Cancer Patients
EXHALE
"EXHALE" A Randomized Clinical Trial Comparing the Effects of a 12 Week Supervised Exercise Intervention Versus Usual Care for Advanced Stage Lung Cancer Patients.
2 other identifiers
interventional
219
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2017
CompletedSeptember 6, 2018
September 1, 2018
5.2 years
June 17, 2013
September 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Muscle strength 1RM
baseline - 12 weeks
Functional capacity 6 Minute walk distance (6MWD) test
baseline- 12 weeks
Forced Expiratory Volume in 1 second (FEV1)
baseline - 12 weeks
Other Outcomes (1)
patient reported outcome
baseline - 12 weeks
Study Arms (2)
Control - usual care
OTHERThe 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.
Exercise + usual care
OTHERThe supervised exercise training is carried out in groups of 12-16 patients and each session has a duration of 1.5 hours. 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. The practical aim of strength training was to complete 3 series of 5-8 sets, with 70-90% of 1RM. 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.
Interventions
Eligibility Criteria
You may qualify if:
- Non small cell lung cancer stage IIIb-IV
- Small cell lung cancer Extensiv disease
- Patients \>18 years
- WHO performance status 0-2
- undergoing chemotherapy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Copenhagen
Copenhagen, 2100, Denmark
Related Publications (1)
Quist M, Langer SW, Rorth M, Christensen KB, Adamsen L. "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. BMC Cancer. 2013 Oct 14;13:477. doi: 10.1186/1471-2407-13-477.
PMID: 24124893DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D, post doc Research physiotherapist
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 20, 2013
Study Start
February 1, 2012
Primary Completion
April 12, 2017
Study Completion
April 12, 2017
Last Updated
September 6, 2018
Record last verified: 2018-09