Exercise During the Allogeneic Stem Cell Transplantation

Fatigue Clinical Trial

Official title:

Exercise During the Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00883714
• Other study ID #: EA4/030/09
• 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