NCT03066271.

Trial name or title	Pre Radiotherapy Daily Exercise Training in Non‐Small Cell Lung Cancer (PRIME)
Methods	Randomised controlled trial Setting: Denmark Study duration: 6 weeks
Participants	Inclusion criteria: non‐small cell lung cancer treated with concomitant chemo‐ and radiotherapy; age: > 18 year; WHO performance status 0‐1. Exclusion criteria: patients with any symptoms or circumstances that advise against physical activity; symptomatic heart disease; congestive heart failure; inability to read and speak Danish; brain or bone metastases; prolonged bone marrow suppression; anti‐coagulant treatment; inability to provide informed consent.
Interventions	Control: patients randomised to the control group received no exercise training but were equipped with a Garmin vivo‐smart HR® activity tracker every day in 24h during the course of radiotherapy treatment. Intervention: patients randomised to the intervention group received supervised daily exercise training (Monday to Friday) on a cycle ergometer for 20 minutes prior to radiotherapy treatment. The training comprised a warm‐up phase followed by 3 exercise phases. Warm‐up consisted of 5 mins light stationary cycling, adjusted to 50% to 60% of the patient's peak power output determined at the incremental cycle test (iPPO). The first exercise phase comprised of 5 mins interval training consisting of 5 x 30 sec intervals at 80% to 95% of the patient's iPPO. Between each interval, there was a 30 sec pause. The second exercise phase consisted of 5 mins continuous cycling at an intensity equalling 80% of the patient's iPPO. The third exercise phase was similar to the first exercise phase. Intensities increased progressively from the first week to the last week (from 50%, 80% and 70% of iPPO according to the three different phases, to 60%, 95% and 80% of iPPO respectively). Furthermore, patients were equipped with a Garmin vivo‐smart HR® activity tracker every day in 24h during the course of radiotherapy treatment.
Outcomes	Exercise capacity (VO2peak and 6MWD), lung function (FEV1, ventilation and tidal volume measured by indirect calorimetry), hypoxia in tumor (dynamic contrast‐enhanced magnetic resonance imaging), stroke volume, cardiac output, systemic vascular resistance, safety (sports‐injury, pain, neuropathies, nausea/vomiting, fatigue etc.), respiratory exchange ration, rated perceived exertion, overall survival rate, physical activity (International Physical Activity Questionnaire Long), quality of life and well‐being (Functional Assessment of Cancer Therapy ‐ Lung), anxiety and depression (Hospital Anxiety and Depression Scale), activity data (steps, distance and intensity minutes measured by Garmin vivo‐smart HR® activity tracker).
Starting date	3 April 2017
Contact information	Morten Quist: morten.quist@regionh.dk
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