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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00883714
Other study ID # EA4/030/09
Secondary ID
Status Recruiting
Phase Phase 3
First received April 17, 2009
Last updated December 21, 2009
Start date May 2009
Est. completion date August 2011

Study information

Verified date December 2009
Source Charite University, Berlin, Germany
Contact Fernando Dimeo, MD
Phone +493084452098
Email fernando.dimeo@charite.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Allogeneic Stem Cell Transplantation
  • Fatigue

Intervention

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.
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.

Locations

Country Name City State
Germany Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary VO2max At recruitment and after 4 weeks No
Secondary Complications 4 weeks No
Secondary Mood At recruitment and after 4 weeks No
Secondary Requirement for blood and platelets transfusions 4 weeks No
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