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Cognition in Allogeneic Stem Cell Transplanted Patients and Sports (CaSpo)

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ClinicalTrials.gov Identifier: NCT02533947
Recruitment Status : Recruiting
First Posted : August 27, 2015
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Deutsche José Carreras Leukämie-Stiftung (DJCLS)
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment Phase
Allogeneic Stem Cell Transplantation Exercise Intervention Behavioral: Exercise Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. Change in cognitive functioning as assessed by Change in total z-score [ Time Frame: 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 :
  1. Change in cognitive functioning as assessed by Change in total z-score [ Time Frame: 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).

  2. Change in self-reported cognitive functioning as assessed by Change in scale sum score (composite score) of the FEDA and FLei questionnaires [ Time Frame: 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).

  3. Change in fine-motor function [ Time Frame: Baseline, 4 months, 7 months ]
    Change in z-score derived from the GPT dominant hand

  4. Change in physical fitness (muscle strength) [ Time Frame: Baseline, 4 months, 7 months ]
    Measured with M. quadriceps isometric strength test, one 10-sec trial on each leg (change in mean strength value)

  5. Change in physical ability/capability (walking ability) [ Time Frame: Baseline, 4 months, 7 months ]
    Measured with the 6-min walk test (change in walk distance in meters)

  6. Change in physical activity (intensity) [ Time Frame: Baseline, 7 months ]
    Measured with accelerometry, 1-week period (change in metabolic equivalent task [MET] values)

  7. Change in self-reported physical activity [ Time Frame: Baseline, 4 months, 7 months ]
    Measured with the EPIC Physical Activity Questionnaire

  8. Change in immunological functions [ Time Frame: Baseline, 4 months, 7 months ]
    Severity of GvHD

  9. Change in health-related quality of life [ Time Frame: Baseline, 4 months, 7 months ]
    Measured with the EORTC QLQ-C30 (change in global health status / QoL scale)

  10. Change in fatigue [ Time Frame: Baseline, 4 months, 7 months ]
    Measured with the MFI-20 (change in total score)

  11. Change in anxiety [ Time Frame: Baseline, 4 months, 7 months ]
    Measured with the HADS subscale anxiety (change in subscale score)

  12. Change in depressive symptoms [ Time Frame: Baseline, 4 months, 7 months ]
    Measured with the HADS subscale depression (change in subscale score)

  13. Change in fear of cancer recurrence [ Time Frame: Baseline, 4 months, 7 months ]
    Measured with the PA-F12 (change in sum score)


Other Outcome Measures:
  1. Intentional behaviour related to physical activity [ Time Frame: 4 months, 7 months ]
    Measured with the stage of change component of the transtheoretical model

  2. Self-efficacy towards physical exercise [ Time Frame: 4 months, 7 months ]
    Measured with three items (Fuchs, 2008)

  3. Situational barriers for physical exercise [ Time Frame: 4 months, 7 months ]
    Measured with the scale on situational barriers (13 items, Krämer & Fuchs, 2010)

  4. Grip strength [ Time Frame: Baseline, 4 months, 7 months ]
    Measured with a handgrip dynamometer

  5. Inflammation [ Time Frame: Baseline, 4 months, 7 months ]
    High-sensitivity CRP derived from routine blood samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533947


Contacts
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Contact: Angela Scherwath, Dr. phil. +49(40) 7410- 57565 a.scherwath@uke.de
Contact: Karl-Heinz Schulz, Prof.Dr.Dr. +49(40) 7410- 54132 khschulz@uke.de

Locations
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Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Angela Scherwath, Dr. phil.    +49(40) 7410- 57565    a.scherwath@uke.de   
Contact: Karl-Heinz Schulz, Prof.Dr.Dr.    +49(40) 7410- 54132    khschulz@uke.de   
Principal Investigator: Karl-Heinz Schulz, Prof.Dr.Dr.         
Sub-Investigator: Angela Scherwath, Dr. phil.         
Sub-Investigator: Stefan Patra         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Deutsche José Carreras Leukämie-Stiftung (DJCLS)
Investigators
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Principal Investigator: Karl-Heinz Schulz, Prof.Dr.Dr. Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02533947     History of Changes
Other Study ID Numbers: CaSpo
DJCLS R 13/23 ( Other Grant/Funding Number: Deutsche José Carreras Leukämie-Stiftung (DJCLS) )
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Allogeneic Stem Cell Transplantation
Hematological Malignancies
Exercise Intervention
Cognitive Function
Fatigue
Randomized Controlled Trial