Cognitive Function After Stem Cell Transplantation

Phase 3

• Conditions: Fatigue; Cognitive Impairment; Stem Cell Transplantation
• Interventions: Other: Endurance exercise; Other: Counseling

• Registration Number: NCT00884338
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Study Start: 2009-05
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-18
• Last Update Posted: 2009-12-21
• Primary Completion: 2011-08
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Endurance exercise	-
Control group	Counseling	-

Primary Outcome Measures

Name	Time	Method
VO2max	Recruitment and after 8 weeks

Secondary Outcome Measures

Name	Time	Method
Cognitive status, mood, quality of life	At recruitment and after 8 weeks

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany