Cognitive Function After Stem Cell Transplantation

Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00884338

Enrollment

Registered

2009-04-20

Start date

2009-05-31

Completion date

2011-09-30

Last updated

2009-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Cognitive Impairment, Stem Cell Transplantation

Keywords

Fatigue, Cancer, Cognitive impairment, Exercise, Sport, Peripheral blood stem cell transplantation, High-dose chemotherapy

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.

Interventions

OTHEREndurance 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

OTHERCounseling

Counseling about exercise and behavioural techniques to reduce fatigue

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
VO2max	Recruitment and after 8 weeks

Secondary

Measure	Time frame
Cognitive status, mood, quality of life	At recruitment and after 8 weeks

Countries

Germany

Contacts

Primary ContactFernando Dimeo, MD

fernando.dimeo@charite.de+493084452098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026