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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Fatigue
Cognitive Impairment
Stem Cell Transplantation
 Other: Endurance exercise
Other: Counseling
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • VO2max [ Time Frame: Recruitment and after 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive status, mood, quality of life [ Time Frame: At recruitment and after 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise 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
Active Comparator: Control group Other: Counseling
Counseling about exercise and behavioural techniques to reduce fatigue

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Dementia
  • PBSCT in the previous 6 weeks
  • Pathological stress test at admission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884338

Contacts
Contact: Fernando Dimeo, MD +493084452098 fernando.dimeo@charite.de

Locations
Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 12200
Contact: Fernando Dimeo, MD     +493084452098     fernando.dimeo@charite.de    
Principal Investigator: Fernando Dimeo, MD            
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Fernando Dimeo, MD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Dr. Fernando Dimeo, Charite Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00884338     History of Changes
Other Study ID Numbers: EA4/028/09
Study First Received: April 17, 2009
Last Updated: December 18, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Fatigue
Cancer
Cognitive impairment
Exercise
 Sport
Peripheral blood stem cell transplantation
High-dose chemotherapy

Additional relevant MeSH terms:
Fatigue
Cognition Disorders
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013