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Exercise During the Allogeneic 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:
NCT00883714
First received: April 17, 2009
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Fatigue
Allogeneic Stem Cell Transplantation
 Other: Supervised exercise
Other: Exercise Instruction
 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
Official Title: Exercise During the Allogeneic Stem Cell Transplantation

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 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: At recruitment and after 4 weeks ] [ Designated as safety issue: No ]
  • Requirement for blood and platelets transfusions [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: August 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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 23, 2013