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Table 1 Overview Primary and Secondary outcome measures

From: Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: A randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue

Outcome measures Instrument
A. Primary outcome measures  
Cardiorespiratory fitness Maximum exercise test (peakVO2 )
Muscular strength 30 s sit-to-stand test, maximal handgrip strength
Fatigue Multidimensional Fatigue Inventory (MFI) [38] and the Fatigue Quality List (FQL) [40] questionnaires
B. Secondary outcome measures  
Sociodemographic data Age, education, marital status, living situation, comorbidities and life style variables (e.g. smoking)
Clinical data  
Medical history Date of diagnosis, subtype of disease, stage of disease, history of therapy
Disease status and treatment Response to treatment, progression or relapse of disease and data on any additional treatment will be recorded from medical records
Adverse events Medical records, reports of the sports physician and physical therapist
Physical tests  
Physical examination Height, weight, waist and hip circumferences, four skinfolds (biceps, triceps, suprailiacal and subscapular)
Body composition and bone mineral density Dual Energy X-ray (DXA) scan
Questionnaires  
Health-related quality of life EORTC Quality of Life Questionnaire C30 (EORTC QLQ-C30) [43], EuroQol (EQ5D) [44], EORTC Chemotherapy-induced peripheral neuropathy module (QLQ-CIPN20) [45]
Physical activity Physical Activity Scale for the Elderly (PASE) [46], Recordings of the Actitrainer accelerometer (Actigraph, Fort Walton Beach Florida, USA)
Mood disturbance Hospital Anxiety and Depression Scale (HADS) [47, 48]
Functioning in daily life Impact on Participation and Autonomy (IPA) [49]
Quality of Sleep Pittsburgh Sleep Quality Index (PSQI) [50]
Return to work Return to work questionnaire
Moderating variables Questionnaire about pre-illness lifestyle, current attitudes toward and beliefs about exercise in general
Satisfaction with the intervention Satisfaction questionnaire
Cost questionnaires Cost dairies
Compliance with the exercise program Self-report and objective measures (e.g. attendance, exercise logs, target intensity)