Cognitive Function After Stem Cell Transplantation

Fatigue Clinical Trial

Official title:

Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00884338
• Other study ID #: EA4/028/09
• 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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Fatigue
• Stem Cell Transplantation

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