FatiguePhase 3NCT00884338
Cognitive Function After Stem Cell Transplantation
A Phase 3 study testing Endurance exercise and Counseling in people with Fatigue and Cognitive Impairment, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The trial will evaluate the effects of an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatigue, Cognitive Impairment, Stem Cell Transplantation
- What is being tested?
- Endurance exercise and Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Sep 2011
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70
- Hematological neoplastic disease
- Treatment with high-dose chemotherapy with peripheral blood stem cell transplantation in the previous 3 years
- Karnofsky-Index > 80%
- Ability to understand German
Who cannot join
- Cardiorespiratory, metabolic, inflammatory or osteoarticular diseases which can be aggravated by exercise
- Psychosis
- Organic brain damage
- Dementia
- PBSCT in the previous 6 weeks
- Pathological stress test at admission
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 12200
Fernando Dimeo, MD, +493084452098, fernando.dimeo@charite.de
Fernando Dimeo, MD
About this study
Official title: Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation
The trial will evaluate the effects of an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.
Read the detailed description
Patients (n = 60) will be randomized to an exercise or a control group. The randomization will be stratified for allogeneic or autologous blood stem cell transplantation. Patients in the exercise group will carry out an endurance training consisting of walking on a treadmill at a speed corresponding to 80% of the maximum heart rate. The exercise program will be carried out 3 times weekly for 8 weeks. Patients in the control group will receive counseling about exercise and behavioural techniques to reduce fatigue, but they will not participate at a structured exercise program. Physical performance (VO2max), cognitive function, mood and quality of life will be evaluated at recruitment and after 8 weeks.
- Conditions
- Fatigue, Cognitive Impairment, Stem Cell Transplantation
- Being tested
- Endurance exercise, Counseling
- Keywords
- Fatigue, Cancer, Cognitive impairment, Exercise, Sport, Peripheral blood stem cell transplantation, High-dose chemotherapy
- Medical subject headings
- Fatigue, Cognitive Dysfunction, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance exerciseOther
The patients will carry out an endurance exercise program consisting of walking on a treadmill for 30 to 40 minutes at a speed corresponding to 80% of the maximum heart rate
CounselingOther
Counseling about exercise and behavioural techniques to reduce fatigue
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Other: Endurance exercise |
| Control group | Active comparator | Not described Receives: Other: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Measured: Recruitment and after 8 weeks
Secondary outcomes (1)
Cognitive status, mood, quality of life
Measured: At recruitment and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Fernando Dimeo, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884338
- Sponsor's protocol ID
- EA4/028/09
- Status last verified
- Dec 2009
- First submitted
- 17 Apr 2009
- Last updated
- 21 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00884338
- Acronym / sponsor ID
- EA4/028/09
- Conditions
- Fatigue, Cognitive Impairment, Stem Cell Transplantation
- Keywords
- Fatigue, Cancer, Cognitive impairment, Exercise, Sport, Peripheral blood stem cell transplantation, High-dose chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 20 Apr 2009 (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.
The trial will evaluate the effects of an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.
Detailed description
Patients (n = 60) will be randomized to an exercise or a control group. The randomization will be stratified for allogeneic or autologous blood stem cell transplantation. Patients in the exercise group will carry out an endurance training consisting of walking on a treadmill at a speed corresponding to 80% of the maximum heart rate. The exercise program will be carried out 3 times weekly for 8 weeks. Patients in the control group will receive counseling about exercise and behavioural techniques to reduce fatigue, but they will not participate at a structured exercise program. Physical performance (VO2max), cognitive function, mood and quality of life will be evaluated at recruitment and after 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Endurance exercise |
| Control group | Active comparator | Other: Counseling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 70
- Hematological neoplastic disease
- Treatment with high-dose chemotherapy with peripheral blood stem cell transplantation in the previous 3 years
- Karnofsky-Index > 80%
- Ability to understand German
Key exclusion criteria (6 listed)
- Cardiorespiratory, metabolic, inflammatory or osteoarticular diseases which can be aggravated by exercise
- Psychosis
- Organic brain damage
- Dementia
- PBSCT in the previous 6 weeks
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 |
|---|---|---|
| Endurance exerciseThe patients will carry out an endurance exercise program consisting of walking on a treadmill for 30 to 40 minutes at a speed corresponding to 80% of the maximum heart rate | Other | Exercise |
| CounselingCounseling about exercise and behavioural techniques to reduce fatigue | Other | Control group |
Primary outcome
VO2max
Time frame: Recruitment and after 8 weeks
1 secondary outcome
Cognitive status, mood, quality of life
Time frame: At recruitment and after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2009.
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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.
Fernando Dimeo, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endurance exercise and Counseling in people with Fatigue and Cognitive Impairment, run by Charite University, Berlin, Germany 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 5 inclusion and 6 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 21 Dec 2009. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fernando Dimeo, MD (+493084452098, fernando.dimeo@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max (time frame: Recruitment and after 8 weeks). 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 21 Dec 2009; AzTrials last refreshed its copy on 28 Oct 2026.