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Cognitive Function After Stem Cell Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00884338
First Posted: April 20, 2009
Last Update Posted: December 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
April 17, 2009
April 20, 2009
December 21, 2009
May 2009
August 2011   (Final data collection date for primary outcome measure)
VO2max [ Time Frame: Recruitment and after 8 weeks ]
Same as current
Complete list of historical versions of study NCT00884338 on ClinicalTrials.gov Archive Site
Cognitive status, mood, quality of life [ Time Frame: At recruitment and after 8 weeks ]
Same as current
Not Provided
Not Provided
 
Cognitive Function After Stem Cell Transplantation
Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Fatigue
  • Cognitive Impairment
  • Stem Cell Transplantation
  • Other: Endurance exercise
    The patients will carry out an endurance exercise program consisting of walking on a treadmill for 30 to 40 minutes at a speed corresponding to 80% of the maximum heart rate
  • Other: Counseling
    Counseling about exercise and behavioural techniques to reduce fatigue
  • Experimental: Exercise
    Intervention: Other: Endurance exercise
  • Active Comparator: Control group
    Intervention: Other: Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
September 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00884338
EA4/028/09
No
Not Provided
Not Provided
Dr. Fernando Dimeo, Charite Universitätsmedizin Berlin
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Fernando Dimeo, MD Charite University, Berlin, Germany
Charite University, Berlin, Germany
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP