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Exercise During Chemotherapy for Patients With Hematological Malignancies

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:
NCT00884364
First received: April 17, 2009
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Exercise During Chemotherapy for Patients With Hematological Malignancies

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Fatigue [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: No ]
  • Physical performance [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: Yes ]

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

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

No publications provided

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

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
Hematologic Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on June 17, 2013