Allogeneic Stem Cell TransplantationCaSpoNCT02533947
Cognition in Allogeneic Stem Cell Transplanted Patients and Sports
A study testing Exercise in people with Allogeneic Stem Cell Transplantation and Exercise Intervention, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Allogeneic Stem Cell Transplantation, Exercise Intervention
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- ≥ 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
Who cannot join
- > 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)
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- 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):
- > 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Angela Scherwath, Dr. phil., +49(40) 7410- 57565, a.scherwath@uke.de
Karl-Heinz Schulz, Prof.Dr.Dr., +49(40) 7410- 54132, khschulz@uke.de
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise, Control
- Keywords
- Allogeneic Stem Cell Transplantation, Hematological Malignancies, Exercise Intervention, Cognitive Function, Fatigue, Randomized Controlled Trial
- Medical subject headings
- Hematologic Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components.
ControlBehavioural
A waitlist control group will get the intervention after 7 month of treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The exercise program will be developed through a pilot phase with 10 patients prior to the start of the main study. Receives: Behavioral: Exercise |
| Control group | Other | A waitlist control group will get the intervention after 7 month of treatment as usual. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 4 months
Secondary outcomes (13)
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).
Measured: 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).
Measured: Baseline, 4 months, 7 months
Change in fine-motor function
Change in z-score derived from the GPT dominant hand
Measured: 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)
Measured: 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)
Measured: Baseline, 4 months, 7 months
Change in physical activity (intensity)
Measured with accelerometry, 1-week period (change in metabolic equivalent task [MET] values)
Measured: Baseline, 7 months
Change in self-reported physical activity
Measured with the EPIC Physical Activity Questionnaire
Measured: Baseline, 4 months, 7 months
Change in immunological functions
Severity of GvHD
Measured: 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)
Measured: Baseline, 4 months, 7 months
Change in fatigue
Measured with the MFI-20 (change in total score)
Measured: Baseline, 4 months, 7 months
Change in anxiety
Measured with the HADS subscale anxiety (change in subscale score)
Measured: Baseline, 4 months, 7 months
Change in depressive symptoms
Measured with the HADS subscale depression (change in subscale score)
Measured: Baseline, 4 months, 7 months
Change in fear of cancer recurrence
Measured with the PA-F12 (change in sum score)
Measured: Baseline, 4 months, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche José Carreras Leukämie-Stiftung (DJCLS)
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Schulz, Prof.Dr.Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533947
- Sponsor's protocol ID
- CaSpo
- Other IDs
- DJCLS R 13/23
- Acronym
- CaSpo
- Status last verified
- Apr 2019
- First submitted
- 2 Mar 2015
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise on Cognitive Functions in Patients After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02533947
- Acronym / sponsor ID
- CaSpo / CaSpo
- Keywords
- Allogeneic Stem Cell Transplantation, Hematological Malignancies, Exercise Intervention, Cognitive Function, Fatigue, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Deutsche José Carreras Leukämie-Stiftung (DJCLS)
- Study start
- Jun 2014
- Primary completion
- May 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: ExerciseThe exercise program will be developed through a pilot phase with 10 patients prior to the start of the main study. |
| Control group | Other | Behavioral: ControlA waitlist control group will get the intervention after 7 month of treatment as usual. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- > 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components. | Behavioural | Exercise group |
| ControlA waitlist control group will get the intervention after 7 month of treatment as usual. | Behavioural | Control group |
Primary outcome
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).
13 secondary outcomes
Change in cognitive functioning as assessed by Change in total z-score
Time frame: 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 fine-motor function
Time frame: Baseline, 4 months, 7 months
Change in physical fitness (muscle strength)
Time frame: Baseline, 4 months, 7 months
Change in physical ability/capability (walking ability)
Time frame: Baseline, 4 months, 7 months
Change in physical activity (intensity)
Time frame: Baseline, 7 months
Change in self-reported physical activity
Time frame: Baseline, 4 months, 7 months
Change in immunological functions
Time frame: Baseline, 4 months, 7 months
Change in health-related quality of life
Time frame: Baseline, 4 months, 7 months
Change in fatigue
Time frame: Baseline, 4 months, 7 months
Change in anxiety
Time frame: Baseline, 4 months, 7 months
Change in depressive symptoms
Time frame: Baseline, 4 months, 7 months
Change in fear of cancer recurrence
Time frame: Baseline, 4 months, 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Heinz Schulz, Prof.Dr.Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Allogeneic Stem Cell Transplantation and Exercise Intervention, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Scherwath, Dr. phil. (+49(40) 7410- 57565, a.scherwath@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive functioning as assessed by Change in total z-score (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.