Exercise Following Autologous Peripheral Blood Stem Cell Transplantation

Hematological Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00883961
• Other study ID #: EA4/029/09
• Status: Recruiting
• Phase: Phase 3
• First received: April 17, 2009
• Last updated: December 21, 2009
• Start date: December 2009
• Est. completion date: September 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 evaluates the effects of a supervised exercise program on the physical performance, the mood and the complications of therapy in patients undergoing a high-dose chemotherapy followed by an autologous peripheral blood stem cell transplantation.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Age 18-70

• Hematological disease

• Treatment with high-dose chemotherapy followed by autologous stem cell transplantation

• Understanding of written German

Exclusion Criteria:

• Cardiorespiratory, metabolical, osteoarticular or immunological diseases 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

• Hematologic Diseases
• Hematological Disease

Intervention

Other:
• Supervised exercise
The patients will carry out a daily endurance exercise program consisting of walking on a treadmill for 30 minutes at an intensity of about 80% of the maximum heart rate under supervision from study personnel.

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 3 weeks	No
Secondary	Mood		At recruitment and after 3 weeks	No
Secondary	Duration of aplasia		3 weeks	No
Secondary	Complications during hospitalization		3 weeks	No
Secondary	Need for transfusion of platelets and red blood cells		3 weeks	No