NCT00883714UnknownPhase 3
Exercise During the Allogeneic Stem Cell Transplantation
Charite University, Berlin, Germany2 sites in 1 country60 target enrollmentStarted: May 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- VO2max
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
VO2max
Time Frame: At recruitment and after 4 weeks
Secondary Outcomes
- Mood(At recruitment and after 4 weeks)
- Complications(4 weeks)
- Requirement for blood and platelets transfusions(4 weeks)
Investigators
Study Sites (2)
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