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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00884338
Other study ID # EA4/028/09
Secondary ID
Status Recruiting
Phase Phase 3
First received April 17, 2009
Last updated December 18, 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 an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.


Description:

Patients (n = 60) will be randomized to an exercise or a control group. The randomization will be stratified for allogeneic or autologous blood stem cell transplantation. Patients in the exercise group will carry out an endurance training consisting of walking on a treadmill at a speed corresponding to 80% of the maximum heart rate. The exercise program will be carried out 3 times weekly for 8 weeks. Patients in the control group will receive counseling about exercise and behavioural techniques to reduce fatigue, but they will not participate at a structured exercise program. Physical performance (VO2max), cognitive function, mood and quality of life will be evaluated at recruitment and after 8 weeks.


Recruitment information / eligibility

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

- Age 18 - 70

- Hematological neoplastic disease

- Treatment with high-dose chemotherapy with peripheral blood stem cell transplantation in the previous 3 years

- Karnofsky-Index > 80%

- Ability to understand German

Exclusion Criteria:

- Cardiorespiratory, metabolic, inflammatory or osteoarticular diseases which can be aggravated by exercise

- Psychosis

- Organic brain damage

- Dementia

- PBSCT in the previous 6 weeks

- Pathological stress test at admission

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Other:
Endurance exercise
The patients will carry out an endurance exercise program consisting of walking on a treadmill for 30 to 40 minutes at a speed corresponding to 80% of the maximum heart rate
Counseling
Counseling about exercise and behavioural techniques to reduce fatigue

Locations

Country Name City State
Germany Charité Universitätsmedizin Berlin 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 Recruitment and after 8 weeks No
Secondary Cognitive status, mood, quality of life At recruitment and after 8 weeks No
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