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Exercise During the Allogeneic Stem Cell Transplantation

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. Identifier: NCT00883714
Recruitment Status : Unknown
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : April 20, 2009
Last Update Posted : December 23, 2009
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
The study will evaluate the effects of a structured endurance exercise program on the physical performance, the mood and the complications of patients with hematological malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood stem cell transplantation.

Condition or disease Intervention/treatment Phase
Fatigue Allogeneic Stem Cell Transplantation Other: Supervised exercise Other: Exercise Instruction Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Exercise During the Allogeneic Stem Cell Transplantation
Study Start Date : May 2009
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Supervised exercise Other: Supervised exercise
The patients will carry out a daily exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The patients will be supervised by medical personnel.

Active Comparator: Control group Other: Exercise Instruction
The patients will receive instructions about exercise and will have access to a bike ergometer to work out. However, they will not receive daily supervision or participate in a structured exercise program.

Primary Outcome Measures :
  1. VO2max [ Time Frame: At recruitment and after 4 weeks ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: 4 weeks ]
  2. Mood [ Time Frame: At recruitment and after 4 weeks ]
  3. Requirement for blood and platelets transfusions [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Neoplastic malignancy
  • Allogeneic peripheral stem cell transplantation
  • Proficiency in German

Exclusion Criteria:

  • Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise
  • Pathological stress-ECG at admission

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 identifier (NCT number): NCT00883714

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Contact: Fernando Dimeo, MD +493084452098

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Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 Recruiting
Berlin, Germany, 12200
Contact: Fernando Dimeo, MD    +493084452098   
Principal Investigator: Fernando Dimeo, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Fernando Dimeo, MD Charite University, Berlin, Germany

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Responsible Party: Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin Identifier: NCT00883714     History of Changes
Other Study ID Numbers: EA4/030/09
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009
Keywords provided by Charite University, Berlin, Germany:
Allogeneic blood stem cell transplantation
Blood stem cell transplantation
Physical performance
Additional relevant MeSH terms:
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Signs and Symptoms