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Table 1 Study outcomes, instruments and assessment points

From: Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD (IRENE-G study) – design and rational of a randomized controlled trial

Outcomes

Instrument

t0

t1

t2

t3

t4

Primary endpoint

 Physical performance

Short Physical Performance Battery

x

x

x

x

x

Secondary endpoints

 Muscle strength

Hand-grip test, Hand-held Dynamometer

x

x

x

x

x

 Muscle volume

Ultrasound

x

  

x

x

 Submaximal endurance capacity

6 minutes walk test

x

x

x

x

x

 Nutritional status

NRS 2002, hand- grip test, serum albumin, total protein levels

x

x

x

x

x

 Quality of life

EORTC QLQ-C30/ HDC-29

x

x

x

x

x

 Fatigue

EORTC QLQ-FA 12

x

x

x

x

x

 GvHD Symptom burden

Modified 7-day Lee cGvHD Symptom Scale

x

x

x

x

x

 Performance status

Karnofsky Performance Scale

x

x

x

x

x

Others

 Socio-demographic factors

Sex, age, marital status, family and living situation, education, employment status and smoking behavior

x

  

x

x

 Physical activity (history)

Physical activity pre-diagnosis and during the intervention

x

x

x

x

x

 Amnestic variables, medical history

Date of diagnosis, subtype of disease, remission status, conditioning regime, history of therapy, date of allo HSCT transplantation, HLA compatibility and comorbidities will be recorded from medical records

x

    

 Anthropometric data

Weight, height

Weekly

 Concomitant medication

Medical log

At each medical outpatient visit

 GvHD course

Physician rating

At each medical outpatient visit

 Adverse events

Medical records, reports of the exercise therapists and/or patient

Surveillance throughout the study

 Adherence to the exercise intervention

Self-reported and objective measures (e.g. attendance, exercise log, target intensity) of the intervention arm only

Surveillance throughout the study