Clinical trial NCT02533947: Cognition in Allogeneic Stem Cell Transplanted Patients and Sports
Official title: Effects of Physical Exercise on Cognitive Functions in Patients After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allogeneic Stem Cell Transplantation
Exercise Intervention
Keywords: Allogeneic Stem Cell Transplantation
Hematological Malignancies
Exercise Intervention
Cognitive Function
Fatigue
Randomized Controlled Trial
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Deutsche José Carreras Leukämie-Stiftung (DJCLS)
First posted: 2015-08-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

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

Primary outcomes:
measure: Change in cognitive functioning as assessed by Change in total z-score
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change in cognitive functioning as assessed by Change in total z-score
timeFrame: Baseline and 7 months
measure: Change in self-reported cognitive functioning as assessed by Change in scale sum score (composite score) of the FEDA and FLei questionnaires
timeFrame: Baseline, 4 months, 7 months
measure: Change in fine-motor function
timeFrame: Baseline, 4 months, 7 months
measure: Change in physical fitness (muscle strength)
timeFrame: Baseline, 4 months, 7 months
measure: Change in physical ability/capability (walking ability)
timeFrame: Baseline, 4 months, 7 months
measure: Change in physical activity (intensity)
timeFrame: Baseline, 7 months
measure: Change in self-reported physical activity
timeFrame: Baseline, 4 months, 7 months
measure: Change in immunological functions
timeFrame: Baseline, 4 months, 7 months
measure: Change in health-related quality of life
timeFrame: Baseline, 4 months, 7 months
measure: Change in fatigue
timeFrame: Baseline, 4 months, 7 months
measure: Change in anxiety
timeFrame: Baseline, 4 months, 7 months
measure: Change in depressive symptoms
timeFrame: Baseline, 4 months, 7 months
measure: Change in fear of cancer recurrence
timeFrame: Baseline, 4 months, 7 months
Other outcomes:
measure: Intentional behaviour related to physical activity
timeFrame: 4 months, 7 months
measure: Self-efficacy towards physical exercise
timeFrame: 4 months, 7 months
measure: Situational barriers for physical exercise
timeFrame: 4 months, 7 months
measure: Grip strength
timeFrame: Baseline, 4 months, 7 months
measure: Inflammation
timeFrame: Baseline, 4 months, 7 months
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Karl-Heinz Schulz, Prof.Dr.Dr.
role: PRINCIPAL_INVESTIGATOR
References: