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 |