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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.
ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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

Study Design

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

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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 ]

Eligibility Criteria

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:

  • 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
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): NCT00883714


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    +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

Responsible Party: Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin
ClinicalTrials.gov 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:
Exercise
sport
Allogeneic blood stem cell transplantation
Blood stem cell transplantation
Fatigue
Cancer
Physical performance
Mood
Complications

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms