Cognition in Allogeneic Stem Cell Transplanted Patients and Sports

Study Overview
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Brief Summary
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Studies suggest that patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and long-term cognitive dysfunction. To address this issue, a randomized controlled intervention trial on the effect of physical exercise on cognition is conducted. In addition, the impact on psychological and physical health outcomes is evaluated. Results may benefit patients who suffer from disease- or treatment-associated cognitive change.

Detailed Description
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Studies suggest that patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and long-term cognitive dysfunction. To address this issue, a randomized controlled intervention trial on the effect of physical exercise on cognition is conducted. In addition, the impact on psychological and physical health outcomes such as depression, fatigue, health-related quality of life and physical fitness is evaluated. A healthy control group matched to the patients on age, gender, and education will be included to both control for practice effects on neuropsychological measures and allow additional comparisons on self-report measures. The healthy control group will undergo neuropsychological testing and questionnaire survey at baseline and 4 months. Demographic data will be collected from all study participants at baseline. Medical data will be collected from patients at all time points. Results may benefit patients who suffer from disease- or treatment-associated cognitive change.

Official Title
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Effects of Physical Exercise on Cognitive Functions in Patients After Allogeneic Stem Cell Transplantation

Conditions
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Allogeneic Stem Cell Transplantation, Exercise Intervention

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Patients: Inclusion Criteria: hematological malignancy (AML, ALL, MDS, OMF, CML, MM, NHL, Hodgkin, AA) 3 to 6 months after allogeneic HSCT ≥ 18 years of age at time of transplantation German as mother tongue regular follow-up visits at the transplantation center during the first year after transplantation Exclusion Criteria: > 75 years of age at time of transplantation relapse/progress thrombocyte count ≤ 50 G/l GvHD with lung involvement compromised lung function (patients who need oxygen) compromised cardiovascular function (< 10-m walk) florid infection immobility neurological disease severe psychiatric disease regular intake of psychoactive drugs or substance abuse uncontrolled diabetes high fracture risk impaired vision and/or hearing Healthy controls (matched for age, gender, and education): Inclusion Criteria: ≥ 18 years of age at time of enrolment German as mother tongue residence in the area of the transplantation center or family members/friends accompanying the patients to clinical follow-up visits Exclusion Criteria: > 75 years of age at time of enrolment hematological malignancy solid tumour disease neurological disease severe psychiatric disease regular intake of psychoactive drugs or substance abuse impaired vision and/or hearing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>The exercise program will be developed through a pilot phase with 10 patients prior to the start of the main study. | Behavioral: Exercise<br>* The intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components.<br>|
| Other: Control group<br>A waitlist control group will get the intervention after 7 month of treatment as usual. | Behavioral: Control<br>* A waitlist control group will get the intervention after 7 month of treatment as usual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive functioning as assessed by Change in total z-score | Change in total z-score derived from a neuropsychological test battery (TMT-A, TMT-B, subtests Alertness, Sustained Attention and Flexibility from the German TAP, German Version of the Rey Auditory Verbal Learning Test, Digit Span from the WAIS-IV, German Version of the COWA, Tower of London). | Baseline and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive functioning as assessed by Change in total z-score | Change in total z-score derived from a neuropsychological test battery (TMT-A, TMT-B, subtests Alertness, Sustained Attention and Flexibility from the German TAP, German Version of the Rey Auditory Verbal Learning Test, Digit Span from the WAIS-IV, German Version of the COWA, Tower of London). | Baseline and 7 months | 
| Change in self-reported cognitive functioning as assessed by Change in scale sum score (composite score) of the FEDA and FLei questionnaires | Change in scale sum score of the FEDA and FLei questionnaires measuring self-perceived attentional (FEDA scale 1: Distractibility and Retardation in Mental Processes, FEDA scale 2: Fatigue and Retardation in Activities of Daily Living, FEDA scale 3: Decrease in Drive), memory (FLei scale memory), and executive dysfunctions (FLei scale executive function). | Baseline, 4 months, 7 months | 
| Change in fine-motor function | Change in z-score derived from the GPT dominant hand | Baseline, 4 months, 7 months | 
| Change in physical fitness (muscle strength) | Measured with M. quadriceps isometric strength test, one 10-sec trial on each leg (change in mean strength value) | Baseline, 4 months, 7 months | 
| Change in physical ability/capability (walking ability) | Measured with the 6-min walk test (change in walk distance in meters) | Baseline, 4 months, 7 months | 
| Change in physical activity (intensity) | Measured with accelerometry, 1-week period (change in metabolic equivalent task [MET] values) | Baseline, 7 months | 
| Change in self-reported physical activity | Measured with the EPIC Physical Activity Questionnaire | Baseline, 4 months, 7 months | 
| Change in immunological functions | Severity of GvHD | Baseline, 4 months, 7 months | 
| Change in health-related quality of life | Measured with the EORTC QLQ-C30 (change in global health status / QoL scale) | Baseline, 4 months, 7 months | 
| Change in fatigue | Measured with the MFI-20 (change in total score) | Baseline, 4 months, 7 months | 
| Change in anxiety | Measured with the HADS subscale anxiety (change in subscale score) | Baseline, 4 months, 7 months | 
| Change in depressive symptoms | Measured with the HADS subscale depression (change in subscale score) | Baseline, 4 months, 7 months | 
| Change in fear of cancer recurrence | Measured with the PA-F12 (change in sum score) | Baseline, 4 months, 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allogeneic Stem Cell Transplantation, Hematological Malignancies, Exercise Intervention, Cognitive Function, Fatigue, Randomized Controlled Trial