University Medical Center Hamburg-Eppendorf 20246 Hamburg (Hamburg) GermanyRekrutierend» Google-Maps Ansprechpartner: Angela Scherwath, Dr. phil. Phone: +49(40) 7410- 57565 E-Mail: a.scherwath@uke.de
Studies suggest that patients with hematological malignancies undergoing allogeneic
hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and
long-term cognitive dysfunction. To address this issue, a randomized controlled intervention
trial on the effect of physical exercise on cognition is conducted. In addition, the impact
on psychological and physical health outcomes such as depression, fatigue, health-related
quality of life and physical fitness is evaluated. A healthy control group matched to the
patients on age, gender, and education will be included to both control for practice effects
on neuropsychological measures and allow additional comparisons on self-report measures. The
healthy control group will undergo neuropsychological testing and questionnaire survey at
baseline and 4 months. Demographic data will be collected from all study participants at
baseline. Medical data will be collected from patients at all time points. Results may
benefit patients who suffer from disease- or treatment-associated cognitive change.
1. Change in cognitive functioning as assessed by Change in total z-score (Time Frame - Baseline and 4 months): Change in total z-score derived from a neuropsychological test battery (TMT-A, TMT-B, subtests Alertness, Sustained Attention and Flexibility from the German TAP, German Version of the Rey Auditory Verbal Learning Test, Digit Span from the WAIS-IV, German Version of the COWA, Tower of London).
Secondary outcome:
1. Change in cognitive functioning as assessed by Change in total z-score (Time Frame - Baseline and 7 months): Change in total z-score derived from a neuropsychological test battery (TMT-A, TMT-B, subtests Alertness, Sustained Attention and Flexibility from the German TAP, German Version of the Rey Auditory Verbal Learning Test, Digit Span from the WAIS-IV, German Version of the COWA, Tower of London).
2. Change in self-reported cognitive functioning as assessed by Change in scale sum score (composite score) of the FEDA and FLei questionnaires (Time Frame - Baseline, 4 months, 7 months): Change in scale sum score of the FEDA and FLei questionnaires measuring self-perceived attentional (FEDA scale 1: Distractibility and Retardation in Mental Processes, FEDA scale 2: Fatigue and Retardation in Activities of Daily Living, FEDA scale 3: Decrease in Drive), memory (FLei scale memory), and executive dysfunctions (FLei scale executive function).
3. Change in fine-motor function (Time Frame - Baseline, 4 months, 7 months): Change in z-score derived from the GPT dominant hand
4. Change in physical fitness (muscle strength) (Time Frame - Baseline, 4 months, 7 months): Measured with M. quadriceps isometric strength test, one 10-sec trial on each leg (change in mean strength value)
5. Change in physical ability/capability (walking ability) (Time Frame - Baseline, 4 months, 7 months): Measured with the 6-min walk test (change in walk distance in meters)
6. Change in physical activity (intensity) (Time Frame - Baseline, 7 months): Measured with accelerometry, 1-week period (change in metabolic equivalent task [MET] values)
7. Change in self-reported physical activity (Time Frame - Baseline, 4 months, 7 months): Measured with the EPIC Physical Activity Questionnaire
8. Change in immunological functions (Time Frame - Baseline, 4 months, 7 months): Severity of GvHD
9. Change in health-related quality of life (Time Frame - Baseline, 4 months, 7 months): Measured with the EORTC QLQ-C30 (change in global health status / QoL scale)
10. Change in fatigue (Time Frame - Baseline, 4 months, 7 months): Measured with the MFI-20 (change in total score)
11. Change in anxiety (Time Frame - Baseline, 4 months, 7 months): Measured with the HADS subscale anxiety (change in subscale score)
12. Change in depressive symptoms (Time Frame - Baseline, 4 months, 7 months): Measured with the HADS subscale depression (change in subscale score)
13. Change in fear of cancer recurrence (Time Frame - Baseline, 4 months, 7 months): Measured with the PA-F12 (change in sum score)
