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Cognitive Function After Stem Cell Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00884338
First received: April 17, 2009
Last updated: December 18, 2009
Last verified: December 2009

April 17, 2009
December 18, 2009
May 2009
August 2011   (final data collection date for primary outcome measure)
VO2max [ Time Frame: Recruitment and after 8 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 Blind (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.
 
Recruiting
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
Both
18 Years to 70 Years
No
Contact: Fernando Dimeo, MD +493084452098 fernando.dimeo@charite.de
Germany
 
NCT00884338
EA4/028/09
No
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