Cognition in Allogeneic Stem Cell Transplanted Patients and Sports
- Conditions
- Exercise InterventionAllogeneic Stem Cell Transplantation
- Interventions
- Behavioral: ControlBehavioral: Exercise
- Registration Number
- NCT02533947
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- > 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control A waitlist control group will get the intervention after 7 month of treatment as usual. Exercise group Exercise The exercise program will be developed through a pilot phase with 10 patients prior to the start of the main study.
- Primary Outcome Measures
Name Time Method Change in cognitive functioning as assessed by Change in total z-score Baseline and 4 months 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).
- Secondary Outcome Measures
Name Time Method Change in depressive symptoms Baseline, 4 months, 7 months Measured with the HADS subscale depression (change in subscale score)
Change in physical ability/capability (walking ability) Baseline, 4 months, 7 months Measured with the 6-min walk test (change in walk distance in meters)
Change in cognitive functioning as assessed by Change in total z-score Baseline and 7 months 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).
Change in fine-motor function Baseline, 4 months, 7 months Change in z-score derived from the GPT dominant hand
Change in immunological functions Baseline, 4 months, 7 months Severity of GvHD
Change in physical fitness (muscle strength) Baseline, 4 months, 7 months Measured with M. quadriceps isometric strength test, one 10-sec trial on each leg (change in mean strength value)
Change in self-reported physical activity Baseline, 4 months, 7 months Measured with the EPIC Physical Activity Questionnaire
Change in fatigue Baseline, 4 months, 7 months Measured with the MFI-20 (change in total score)
Change in anxiety Baseline, 4 months, 7 months Measured with the HADS subscale anxiety (change in subscale score)
Change in self-reported cognitive functioning as assessed by Change in scale sum score (composite score) of the FEDA and FLei questionnaires Baseline, 4 months, 7 months 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).
Change in physical activity (intensity) Baseline, 7 months Measured with accelerometry, 1-week period (change in metabolic equivalent task \[MET\] values)
Change in health-related quality of life Baseline, 4 months, 7 months Measured with the EORTC QLQ-C30 (change in global health status / QoL scale)
Change in fear of cancer recurrence Baseline, 4 months, 7 months Measured with the PA-F12 (change in sum score)
Trial Locations
- Locations (1)
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany