Exercise During Chemotherapy for Patients With Hematological Malignancies

Hematological Malignancies Clinical Trial

Official title:

Exercise During Chemotherapy for Patients With Hematological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00884364
• Other study ID #: EA4/031/09
• Status: Recruiting
• Phase: Phase 3
• First received: April 17, 2009
• Last updated: December 21, 2009
• Start date: May 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 trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy for the treatment of a hematological neoplastic disease.

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:

• Hematological malignant disease

• Current chemotherapy

• Understanding of written German

Exclusion Criteria:

• Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise

• Pathological stress-ECG at recruitment

Study Design

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

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematological Diseases
• Hematological Malignancies
• Neoplasms

Intervention

Other:
• Aerobic exercise
The patients will carry out an aerobic exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The training will be carried out three times a week.

Behavioral:
• Fatigue counseling
The patients will receive a counseling regarding the causes of fatigue, how to cope with this symptom, and general recommendations about exercise. However, they will not participate at 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	Fatigue		At recruitment and after 12 weeks	No
Secondary	Complications		At recruitment and after 12 weeks	No
Secondary	Physical performance		At recruitment and after 12 weeks	Yes