Exercise During the Allogeneic Stem Cell Transplantation
Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Unknown status
CT.gov ID
NCT00883714
Collaborator
(none)
60
1
2
27
2.2
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Exercise During the Allogeneic Stem Cell Transplantation
Study Start Date
:
May 1, 2009
Anticipated Primary Completion Date
:
Apr 1, 2011
Anticipated Study Completion Date
:
Aug 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- VO2max [At recruitment and after 4 weeks]
Secondary Outcome Measures
- Complications [4 weeks]
- Mood [At recruitment and after 4 weeks]
- Requirement for blood and platelets transfusions [4 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 | Berlin | Germany | 12200 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Principal Investigator: Fernando Dimeo, MD, Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00883714
Other Study ID Numbers:
- EA4/030/09
First Posted:
Apr 20, 2009
Last Update Posted:
Dec 23, 2009
Last Verified:
Dec 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: