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Exercise Following Autologous Peripheral Blood 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:
NCT00883961
First received: April 17, 2009
Last updated: December 21, 2009
Last verified: December 2009

April 17, 2009
December 21, 2009
December 2009
April 2011   (final data collection date for primary outcome measure)
VO2max [ Time Frame: At recruitment and after 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00883961 on ClinicalTrials.gov Archive Site
  • Mood [ Time Frame: At recruitment and after 3 weeks ] [ Designated as safety issue: No ]
  • Duration of aplasia [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Complications during hospitalization [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Need for transfusion of platelets and red blood cells [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exercise Following Autologous Peripheral Blood Stem Cell Transplantation
Not Provided

The study evaluates the effects of a supervised exercise program on the physical performance, the mood and the complications of therapy in patients undergoing a high-dose chemotherapy followed by an autologous peripheral blood stem cell transplantation.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Hematological Disease
Other: Supervised exercise
The patients will carry out a daily endurance exercise program consisting of walking on a treadmill for 30 minutes at an intensity of about 80% of the maximum heart rate under supervision from study personnel.
  • Experimental: Supervised exercise
    Intervention: Other: Supervised exercise
  • No Intervention: Control group
    The patients will not carry out a structured exercise program.
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
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-70
  • Hematological disease
  • Treatment with high-dose chemotherapy followed by autologous stem cell transplantation
  • Understanding of written German

Exclusion Criteria:

  • Cardiorespiratory, metabolical, osteoarticular or immunological diseases which can be aggravated by exercise
  • Pathological stress-ECG at admission
Both
18 Years to 70 Years
No
Contact: Fernando Dimeo, MD +493084452098 fernando.dimeo@charite.de
Germany
 
NCT00883961
EA4/029/09
No
Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité 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