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

April 28, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Angela Scherwath, Dr. phil.
  • Phone Number: +49(40) 7410- 57565
  • Email: a.scherwath@uke.de

Study Contact Backup

  • Name: Karl-Heinz Schulz, Prof.Dr.Dr.
  • Phone Number: +49(40) 7410- 54132
  • Email: khschulz@uke.de

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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
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).
Baseline, 4 months, 7 months
Change in fine-motor function
Time Frame: Baseline, 4 months, 7 months
Change in z-score derived from the GPT dominant hand
Baseline, 4 months, 7 months
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)
Baseline, 4 months, 7 months
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)
Baseline, 4 months, 7 months
Change in physical activity (intensity)
Time Frame: Baseline, 7 months
Measured with accelerometry, 1-week period (change in metabolic equivalent task [MET] values)
Baseline, 7 months
Change in self-reported physical activity
Time Frame: Baseline, 4 months, 7 months
Measured with the EPIC Physical Activity Questionnaire
Baseline, 4 months, 7 months
Change in immunological functions
Time Frame: Baseline, 4 months, 7 months
Severity of GvHD
Baseline, 4 months, 7 months
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)
Baseline, 4 months, 7 months
Change in fatigue
Time Frame: Baseline, 4 months, 7 months
Measured with the MFI-20 (change in total score)
Baseline, 4 months, 7 months
Change in anxiety
Time Frame: Baseline, 4 months, 7 months
Measured with the HADS subscale anxiety (change in subscale score)
Baseline, 4 months, 7 months
Change in depressive symptoms
Time Frame: Baseline, 4 months, 7 months
Measured with the HADS subscale depression (change in subscale score)
Baseline, 4 months, 7 months
Change in fear of cancer recurrence
Time Frame: Baseline, 4 months, 7 months
Measured with the PA-F12 (change in sum score)
Baseline, 4 months, 7 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intentional behaviour related to physical activity
Time Frame: 4 months, 7 months
Measured with the stage of change component of the transtheoretical model
4 months, 7 months
Self-efficacy towards physical exercise
Time Frame: 4 months, 7 months
Measured with three items (Fuchs, 2008)
4 months, 7 months
Situational barriers for physical exercise
Time Frame: 4 months, 7 months
Measured with the scale on situational barriers (13 items, Krämer & Fuchs, 2010)
4 months, 7 months
Grip strength
Time Frame: Baseline, 4 months, 7 months
Measured with a handgrip dynamometer
Baseline, 4 months, 7 months
Inflammation
Time Frame: Baseline, 4 months, 7 months
High-sensitivity CRP derived from routine blood samples
Baseline, 4 months, 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Deutsche José Carreras Leukämie-Stiftung (DJCLS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karl-Heinz Schulz, Prof.Dr.Dr., Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CaSpo
  • DJCLS R 13/23 (Other Grant/Funding Number: Deutsche José Carreras Leukämie-Stiftung (DJCLS))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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