- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00884364
Exercise During Chemotherapy for Patients With Hematological Malignancies
December 21, 2009 updated by: Charite University, Berlin, Germany
The trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy for the treatment of a hematological neoplastic disease.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 12200
- Recruiting
- Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fatigue
Time Frame: At recruitment and after 12 weeks
|
At recruitment and after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complications
Time Frame: At recruitment and after 12 weeks
|
At recruitment and after 12 weeks
|
Physical performance
Time Frame: At recruitment and after 12 weeks
|
At recruitment and after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (ANTICIPATED)
April 1, 2011
Study Completion (ANTICIPATED)
September 1, 2011
Study Registration Dates
First Submitted
April 17, 2009
First Submitted That Met QC Criteria
April 17, 2009
First Posted (ESTIMATE)
April 20, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 23, 2009
Last Update Submitted That Met QC Criteria
December 21, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA4/031/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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