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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02533947
Other study ID # CaSpo
Secondary ID DJCLS R 13/23
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date August 2019

Study information

Verified date April 2019
Source Universitätsklinikum Hamburg-Eppendorf
Contact Angela Scherwath, Dr. phil.
Phone +49(40) 7410- 57565
Email a.scherwath@uke.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 80
Est. completion date August 2019
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
The intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components.
Control
A waitlist control group will get the intervention after 7 month of treatment as usual.

Locations

Country Name City State
Germany University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (2)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf Deutsche José Carreras Leukämie-Stiftung (DJCLS)

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Intentional behaviour related to physical activity Measured with the stage of change component of the transtheoretical model 4 months, 7 months
Other Self-efficacy towards physical exercise Measured with three items (Fuchs, 2008) 4 months, 7 months
Other Situational barriers for physical exercise Measured with the scale on situational barriers (13 items, Krämer & Fuchs, 2010) 4 months, 7 months
Other Grip strength Measured with a handgrip dynamometer Baseline, 4 months, 7 months
Other Inflammation High-sensitivity CRP derived from routine blood samples Baseline, 4 months, 7 months
Primary 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 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
Secondary 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
Secondary Change in fine-motor function Change in z-score derived from the GPT dominant hand Baseline, 4 months, 7 months
Secondary 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
Secondary 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
Secondary Change in physical activity (intensity) Measured with accelerometry, 1-week period (change in metabolic equivalent task [MET] values) Baseline, 7 months
Secondary Change in self-reported physical activity Measured with the EPIC Physical Activity Questionnaire Baseline, 4 months, 7 months
Secondary Change in immunological functions Severity of GvHD Baseline, 4 months, 7 months
Secondary 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
Secondary Change in fatigue Measured with the MFI-20 (change in total score) Baseline, 4 months, 7 months
Secondary Change in anxiety Measured with the HADS subscale anxiety (change in subscale score) Baseline, 4 months, 7 months
Secondary Change in depressive symptoms Measured with the HADS subscale depression (change in subscale score) Baseline, 4 months, 7 months
Secondary Change in fear of cancer recurrence Measured with the PA-F12 (change in sum score) Baseline, 4 months, 7 months
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