Cognitive Function After Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation

Conditions
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Fatigue, Cognitive Impairment, Stem Cell Transplantation

Intervention / Treatment
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* Other: Endurance exercise
* Other: Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br> | Other: Endurance exercise<br>* 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<br>|
| Active Comparator: Control group<br> | Other: Counseling<br>* Counseling about exercise and behavioural techniques to reduce fatigue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2max |  | Recruitment and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive status, mood, quality of life |  | At recruitment and after 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Cancer, Cognitive impairment, Exercise, Sport, Peripheral blood stem cell transplantation, High-dose chemotherapy