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Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation

Phase 3
18 Years
70 Years
Open (Enrolling)
Fatigue, Cognitive Impairment, Stem Cell Transplantation

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Trial Information

Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation

Patients (n = 60) will be randomized to an exercise or a control group. The randomization
will be stratified for allogeneic or autologous blood stem cell transplantation. Patients in
the exercise group will carry out an endurance training consisting of walking on a treadmill
at a speed corresponding to 80% of the maximum heart rate. The exercise program will be
carried out 3 times weekly for 8 weeks. Patients in the control group will receive
counseling about exercise and behavioural techniques to reduce fatigue, but they will not
participate at a structured exercise program. Physical performance (VO2max), cognitive
function, mood and quality of life will be evaluated at recruitment and after 8 weeks.

Inclusion Criteria:

- Age 18 - 70

- Hematological neoplastic disease

- Treatment with high-dose chemotherapy with peripheral blood stem cell transplantation
in the previous 3 years

- Karnofsky-Index > 80%

- Ability to understand German

Exclusion Criteria:

- Cardiorespiratory, metabolic, inflammatory or osteoarticular diseases which can be
aggravated by exercise

- Psychosis

- Organic brain damage

- Dementia

- PBSCT in the previous 6 weeks

- Pathological stress test at admission

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

Recruitment and after 8 weeks

Safety Issue:


Principal Investigator

Fernando Dimeo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite University, Berlin, Germany


Germany: Ethics Commission

Study ID:




Start Date:

May 2009

Completion Date:

September 2011

Related Keywords:

  • Fatigue
  • Cognitive Impairment
  • Stem Cell Transplantation
  • Fatigue
  • Cancer
  • Cognitive impairment
  • Exercise
  • Sport
  • Peripheral blood stem cell transplantation
  • High-dose chemotherapy
  • Fatigue
  • Cognition Disorders