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Exercise During Chemotherapy for Patients With Hematological Malignancies

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00884364
First Posted: April 20, 2009
Last Update Posted: December 23, 2009
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.
Information provided by:
Charite University, Berlin, Germany
  Purpose
The trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy for the treatment of a hematological neoplastic disease.

Condition Intervention Phase
Hematological Diseases Hematological Malignancies Other: Aerobic exercise Behavioral: Fatigue counseling Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Exercise During Chemotherapy for Patients With Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Fatigue [ Time Frame: At recruitment and after 12 weeks ]

Secondary Outcome Measures:
  • Complications [ Time Frame: At recruitment and after 12 weeks ]
  • Physical performance [ Time Frame: At recruitment and after 12 weeks ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Behavioral: Fatigue counseling
The patients will receive a counseling regarding the causes of fatigue, how to cope with this symptom, and general recommendations about exercise. However, they will not participate at a structured exercise program.
Experimental: Exercise Other: Aerobic exercise
The patients will carry out an aerobic exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The training will be carried out three times a week.

  Eligibility

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:

  • Hematological malignant disease
  • Current chemotherapy
  • Understanding of written German

Exclusion Criteria:

  • Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise
  • Pathological stress-ECG at recruitment
  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): NCT00884364


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

Responsible Party: Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00884364     History of Changes
Other Study ID Numbers: EA4/031/09
First Submitted: April 17, 2009
First Posted: April 20, 2009
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by Charite University, Berlin, Germany:
Lymphoma
Leukemia
Multiple myeloma
Hodgkin´s disease
Exercise
Sport
Fatigue
Hematological neoplastic diseases

Additional relevant MeSH terms:
Neoplasms
Hematologic Diseases