FatiguePhase 3NCT00883714
Exercise During the Allogeneic Stem Cell Transplantation
A Phase 3 study testing Supervised exercise and Exercise Instruction in people with Fatigue and Allogeneic Stem Cell Transplantation, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The study will evaluate the effects of a structured endurance exercise program on the physical performance, the mood and the complications of patients with hematological malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatigue, Allogeneic Stem Cell Transplantation
- What is being tested?
- Supervised exercise and Exercise Instruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Aug 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
- Neoplastic malignancy
- Allogeneic peripheral stem cell transplantation
- Proficiency in German
Who cannot join
- Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise
- Pathological stress-ECG at admission
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
Berlin, State of Berlin, 12200
Fernando Dimeo, MD, +493084452098, fernando.dimeo@charite.de
Fernando Dimeo, MD
About this study
The study will evaluate the effects of a structured endurance exercise program on the physical performance, the mood and the complications of patients with hematological malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood stem cell transplantation.
- Conditions
- Fatigue, Allogeneic Stem Cell Transplantation
- Being tested
- Supervised exercise, Exercise Instruction
- Keywords
- Exercise, sport, Allogeneic blood stem cell transplantation, Blood stem cell transplantation, Fatigue, Cancer, Physical performance, Mood, Complications
- Medical subject headings
- Fatigue, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exerciseOther
The patients will carry out a daily exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The patients will be supervised by medical personnel.
Exercise InstructionOther
The patients will receive instructions about exercise and will have access to a bike ergometer to work out. However, they will not receive daily supervision or participate in a structured exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise | Experimental | Not described Receives: Other: Supervised exercise |
| Control group | Active comparator | Not described Receives: Other: Exercise Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Measured: At recruitment and after 4 weeks
Secondary outcomes (3)
Complications
Measured: 4 weeks
Mood
Measured: At recruitment and after 4 weeks
Requirement for blood and platelets transfusions
Measured: 4 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 completionApr 2011 (estimated)
- Study completionAug 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
- Supportive care
- 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
- NCT00883714
- Sponsor's protocol ID
- EA4/030/09
- Status last verified
- Dec 2009
- First submitted
- 17 Apr 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise During the Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00883714
- Acronym / sponsor ID
- EA4/030/09
- Conditions
- Fatigue, Allogeneic Stem Cell Transplantation
- Keywords
- Exercise, sport, Allogeneic blood stem cell transplantation, Blood stem cell transplantation, Fatigue, Cancer, Physical performance, Mood
- 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
- Apr 2011 (estimated)
- Study completion
- Aug 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 study will evaluate the effects of a structured endurance exercise program on the physical performance, the mood and the complications of patients with hematological malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood stem cell transplantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise | Experimental | Other: Supervised exercise |
| Control group | Active comparator | Other: Exercise Instruction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neoplastic malignancy
- Allogeneic peripheral stem cell transplantation
- Proficiency in German
Key exclusion criteria (2 listed)
- Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise
- Pathological stress-ECG at admission
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 |
|---|---|---|
| Supervised exerciseThe patients will carry out a daily exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The patients will be supervised by medical personnel. | Other | Supervised exercise |
| Exercise InstructionThe patients will receive instructions about exercise and will have access to a bike ergometer to work out. However, they will not receive daily supervision or participate in a structured exercise program. | Other | Control group |
Primary outcome
VO2max
Time frame: At recruitment and after 4 weeks
3 secondary outcomes
Complications
Time frame: 4 weeks
Mood
Time frame: At recruitment and after 4 weeks
Requirement for blood and platelets transfusions
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
Related trials for Fatigue
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruiting
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults
Exercise-Induced Muscle Fatigue, Fatigue Recovery
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
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 Supervised exercise and Exercise Instruction in people with Fatigue and Allogeneic Stem Cell Transplantation, 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 3 inclusion and 2 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 23 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: At recruitment and after 4 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 23 Dec 2009.