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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