Cognition in Allogeneic Stem Cell Transplanted Patients and Sports

Allogeneic Stem Cell Transplantation Clinical Trial

— CaSpo  

Official title:

Effects of Physical Exercise on Cognitive Functions in Patients After Allogeneic Stem Cell Transplantation

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
• 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
• 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

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation
• Exercise Intervention

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