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

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

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.

Study Overview

• Status: Unknown
• Conditions: Allogeneic Stem Cell Transplantation; Exercise Intervention
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Control

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: Angela Scherwath, Dr. phil.; Phone Number: +49(40) 7410- 57565; Email: a.scherwath@uke.de
    • Contact: Karl-Heinz Schulz, Prof.Dr.Dr.; Phone Number: +49(40) 7410- 54132; Email: khschulz@uke.de
    • Principal Investigator: Karl-Heinz Schulz, Prof.Dr.Dr.
    • Sub-Investigator: Angela Scherwath, Dr. phil.
    • Sub-Investigator: Stefan Patra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in fine-motor function	Change in z-score derived from the GPT dominant hand	Baseline, 4 months, 7 months
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
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
Change in physical activity (intensity)	Measured with accelerometry, 1-week period (change in metabolic equivalent task [MET] values)	Baseline, 7 months
Change in self-reported physical activity	Measured with the EPIC Physical Activity Questionnaire	Baseline, 4 months, 7 months
Change in immunological functions	Severity of GvHD	Baseline, 4 months, 7 months
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
Change in fatigue	Measured with the MFI-20 (change in total score)	Baseline, 4 months, 7 months
Change in anxiety	Measured with the HADS subscale anxiety (change in subscale score)	Baseline, 4 months, 7 months
Change in depressive symptoms	Measured with the HADS subscale depression (change in subscale score)	Baseline, 4 months, 7 months
Change in fear of cancer recurrence	Measured with the PA-F12 (change in sum score)	Baseline, 4 months, 7 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intentional behaviour related to physical activity	Measured with the stage of change component of the transtheoretical model	4 months, 7 months
Self-efficacy towards physical exercise	Measured with three items (Fuchs, 2008)	4 months, 7 months
Situational barriers for physical exercise	Measured with the scale on situational barriers (13 items, Krämer & Fuchs, 2010)	4 months, 7 months
Grip strength	Measured with a handgrip dynamometer	Baseline, 4 months, 7 months
Inflammation	High-sensitivity CRP derived from routine blood samples	Baseline, 4 months, 7 months

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Deutsche José Carreras Leukämie-Stiftung (DJCLS)
• Investigators: Principal Investigator: Karl-Heinz Schulz, Prof.Dr.Dr., Universitatsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Fatigue; Randomized Controlled Trial; Exercise Intervention; Allogeneic Stem Cell Transplantation; Cognitive Function; Hematological Malignancies
• Other Study ID Numbers: CaSpo; DJCLS R 13/23 (Other Grant/Funding Number: Deutsche José Carreras Leukämie-Stiftung (DJCLS))