Allogeneic Stem Cell Transplantation, Exercise Intervention
Conditions
Keywords
Allogeneic Stem Cell Transplantation, Hematological Malignancies, Exercise Intervention, Cognitive Function, Fatigue, Randomized Controlled Trial
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.
Interventions
BEHAVIORALExercise
The intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components.
BEHAVIORALControl
A waitlist control group will get the intervention after 7 month of treatment as usual.
Sponsors
Deutsche José Carreras Leukämie-Stiftung (DJCLS)
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 depressive symptoms | Baseline, 4 months, 7 months | Measured with the HADS subscale depression (change in subscale score) |
| Change in fear of cancer recurrence | Baseline, 4 months, 7 months | Measured with the PA-F12 (change in sum score) |
| Change in physical activity (intensity) | Baseline, 7 months | Measured with accelerometry, 1-week period (change in metabolic equivalent task \[MET\] values) |
| Change in self-reported physical activity | Baseline, 4 months, 7 months | Measured with the EPIC Physical Activity Questionnaire |
| Change in immunological functions | Baseline, 4 months, 7 months | Severity of GvHD |
| 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 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 physical ability/capability (walking ability) | Baseline, 4 months, 7 months | Measured with the 6-min walk test (change in walk distance in meters) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Situational barriers for physical exercise | 4 months, 7 months | Measured with the scale on situational barriers (13 items, Krämer & Fuchs, 2010) |
| Grip strength | Baseline, 4 months, 7 months | Measured with a handgrip dynamometer |
| Inflammation | Baseline, 4 months, 7 months | High-sensitivity CRP derived from routine blood samples |
| Intentional behaviour related to physical activity | 4 months, 7 months | Measured with the stage of change component of the transtheoretical model |
| Self-efficacy towards physical exercise | 4 months, 7 months | Measured with three items (Fuchs, 2008) |
Countries
Germany
Contacts
Primary ContactAngela Scherwath, Dr. phil.
Backup ContactKarl-Heinz Schulz, Prof.Dr.Dr.
Outcome results
None listed