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Table 1 Assessments and instruments used in the PETRA study

From: Physical Exercise Training versus Relaxation in Allogeneic stem cell transplantation (PETRA Study) – Rationale and design of a randomized trial to evaluate a yearlong exercise intervention on overall survival and side-effects after allogeneic stem cell transplantation

Outcomes Instrument t0 t1 t2 t3 t4 t5 t6
Primary endpoint
Overall 2-year survival Medical log (ongoing assessment)  
Secondary endpoints
2-year non-relapse mortality, median (disease-free) survival Medical log (ongoing assessment)  
Quality of life EORTC QLQ30 / HDC-29 module X X X X X X X
Fatigue Multidimensional Fatigue Inventory (MFI) X X X X X X X
Muscle strength Isometric and isokinetic strength of representative muscle groups for upper and lower extremity measured at the IsoMed2000® X    X   X X
Hand-Held-Dynamometer (isometric) X X X X X X X
Cardiorespiratory fitness CPET (VO2peak) X    X   X X
  6-min Walk Test X X X X X X X
Body composition bioelectrical impedance analysis, weight, height X X X X X X X
Physical Activity Accelerometry X   X X X X X
Depression CES-D X X X X X X X
Distress NCCN-Distress X X X X X X X
Locus of control KKG (German) X X X X X X X
Cognitive function Trail-making-test X X X X X X X
Common side-effects VAS, every week, later every 3 weeks  
Biomarker Various methods (ELISA) X X X X X X X
Oxidative stress marker Analysed in urine samples X X X X X X X
Others
Socio-demographic factors Recording of date of birth, education, occupation, familial situation, smoking, alcohol consumption X      X X
Medical history Recording of pre-existing diseases, therapies X       
Treatment data Conditioning, complications   X      
Karnofsky Performance Score Physician rating X X X X X X X
Medication (immunosuppression, corticosteroids, analgesics) Recorded at each visit/phone call on a medication log form X X X X X X X
Physical activity history Physical activity in adolescence, pre-diagnosis, during, and after intervention is recorded, including walking, cycling, and sports activities X    X   X X