Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Fatigue
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- VO2max
- Last Updated
- 16 years ago
Overview
Brief Summary
The trial will evaluate the effects of an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.
Detailed Description
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.
Investigators
Eligibility Criteria
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
- •PBSCT in the previous 6 weeks
- •Pathological stress test at admission
Outcomes
Primary Outcomes
VO2max
Time Frame: Recruitment and after 8 weeks
Secondary Outcomes
- Cognitive status, mood, quality of life(At recruitment and after 8 weeks)