Exercise During the Allogeneic Stem Cell Transplantation - Full Text View

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00883714

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 III

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Exercise During the Allogeneic Stem Cell Transplantation

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
Supervised exercise: Experimental	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.
Control group: Active Comparator	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
Berlin, Germany, 12200

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:	Fernando Dimeo, MD	Charité Universitätsmedizin Berlin
Principal Investigator:	Fernando Dimeo, MD	Charité Universitätsmedizin Berlin

More Information

No publications provided

Responsible Party:	Dept. of Sports Medicine, Charité Universitätsmedizin Berlin ( Dr. Fernando Dimeo )
Study ID Numbers:	EA4/030/09
Study First Received:	April 17, 2009
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00883714 History of Changes
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

Study placed in the following topic categories:

Signs and Symptoms
Fatigue

Additional relevant MeSH terms:

Signs and Symptoms
Fatigue

ClinicalTrials.gov processed this record on May 06, 2009