CaSpo: Cognition in Allogeneic Stem Cell Transplanted Patients and Sports

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Unknown status

CT.gov ID

NCT02533947

Collaborator

Deutsche José Carreras Leukämie-Stiftung (DJCLS) (Other)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Stem Cell Transplantation Exercise Intervention	Behavioral: Exercise Behavioral: Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise group The exercise program will be developed through a pilot phase with 10 patients prior to the start of the main study.	Behavioral: Exercise The intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components.
Other: Control group A waitlist control group will get the intervention after 7 month of treatment as usual.	Behavioral: Control A waitlist control group will get the intervention after 7 month of treatment as usual.

Arm

Intervention/Treatment

Experimental: Exercise group

The exercise program will be developed through a pilot phase with 10 patients prior to the start of the main study.

Behavioral: Exercise

The intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components.

Other: Control group

A waitlist control group will get the intervention after 7 month of treatment as usual.

Behavioral: Control

A waitlist control group will get the intervention after 7 month of treatment as usual.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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 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)
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 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)

Other Outcome Measures

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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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