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Exercise Following Autologous Peripheral Blood 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:
NCT00883961
First Posted: April 20, 2009
Last Update Posted: December 23, 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
  Purpose
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.

Condition Intervention Phase
Hematological Disease Other: Supervised exercise Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:


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

Primary Outcome Measures:
  • VO2max [ Time Frame: At recruitment and after 3 weeks ]

Secondary Outcome Measures:
  • Mood [ Time Frame: At recruitment and after 3 weeks ]
  • Duration of aplasia [ Time Frame: 3 weeks ]
  • Complications during hospitalization [ Time Frame: 3 weeks ]
  • Need for transfusion of platelets and red blood cells [ Time Frame: 3 weeks ]

Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supervised exercise 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.
No Intervention: Control group
The patients will not carry out a structured exercise program.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883961


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

Locations
Germany
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 Recruiting
Berlin, Germany, 12200
Contact: Fernando Dimeo, MD         
Principal Investigator: Fernando Dimeo, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Fernando Dimeo, MD Charite University, Berlin, Germany
  More Information

Responsible Party: Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00883961     History of Changes
Other Study ID Numbers: EA4/029/09
First Submitted: April 17, 2009
First Posted: April 20, 2009
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by Charite University, Berlin, Germany:
High-dose chemotherapy
Hematological neoplasties
Fatigue
Cancer
Exercise
Sport
Hematologic neoplastic disorders

Additional relevant MeSH terms:
Hematologic Diseases