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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care

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: At recruitment and after 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 17, 2009
Last Updated: December 21, 2009
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013