Effects of Physical Exercise on Cognitive Functions in Patients After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in cognitive functioning as assessed by Change in total z-score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •> 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
研究组 & 干预措施
Exercise group
The exercise program will be developed through a pilot phase with 10 patients prior to the start of the main study.
干预措施: Exercise (Behavioral)
Control group
A waitlist control group will get the intervention after 7 month of treatment as usual.
干预措施: Control (Behavioral)
结局指标
主要结局
Change in cognitive functioning as assessed by Change in total z-score
时间窗: 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).
次要结局
- Change in depressive symptoms(Baseline, 4 months, 7 months)
- Change in physical ability/capability (walking ability)(Baseline, 4 months, 7 months)
- Change in cognitive functioning as assessed by Change in total z-score(Baseline and 7 months)
- Change in fine-motor function(Baseline, 4 months, 7 months)
- Change in immunological functions(Baseline, 4 months, 7 months)
- Change in physical fitness (muscle strength)(Baseline, 4 months, 7 months)
- Change in self-reported physical activity(Baseline, 4 months, 7 months)
- Change in fatigue(Baseline, 4 months, 7 months)
- Change in anxiety(Baseline, 4 months, 7 months)
- 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 physical activity (intensity)(Baseline, 7 months)
- Change in health-related quality of life(Baseline, 4 months, 7 months)
- Change in fear of cancer recurrence(Baseline, 4 months, 7 months)