Allogeneic Stem Cell TransplantationPhase 3NCT00427115
Multimodal Intervention in Allogeneic Stem Cell Transplantation
A Phase 3 study testing Multimodal exercise and psychosocial program in people with Allogeneic Stem Cell Transplantation and Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise - psycho-educational intervention in patients undergoing allogeneic stem cell transplantation (allo-HCST). The intervention included structured and supervised exercise, relaxation and psycho-educational components. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allogeneic Stem Cell Transplantation, Leukemia
- What is being tested?
- Multimodal exercise and psychosocial program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2005to Apr 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 yrs
- patients undergoing allogeneic stem cell transplantation
Who cannot join
- recent cardiovascular or pulmonary disease
- abnormal EKG
- psychiatric disorder
- motor function, musculoskeletal or neurological disturbances
- bony metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of an Exercise an Psycho-Educational Intervention During Allogeneic Stem Cell Transplantation
Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise - psycho-educational intervention in patients undergoing allogeneic stem cell transplantation (allo-HCST). The intervention included structured and supervised exercise, relaxation and psycho-educational components. It was hypothesized that the intervention would minimize loss of physical capacity during hospitalization.
- Conditions
- Allogeneic Stem Cell Transplantation, Leukemia
- Being tested
- Multimodal exercise and psychosocial program
- Keywords
- Patients undergoing allogeneic stem cell transplantations
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal exercise and psychosocial programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test
Measured: Baseline, post
Secondary outcomes (2)
quality of life indices
Measured: baseline, post, 3 and 6 months
FACT-An, EORTC, HADS, Mini-Mac, Symptom Assessment form
Measured: baseline, post, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study startAug 2005
- Primary completionDec 2007
- Study completionApr 2008
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 Copenhagen University Hospital, RigshospitaletThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Mary E Jarden, MSN PhD stud, Principal investigator, Copenhagen University Hospital, DenmarkLis Adamsen, ProfessorPhD, Study chair, Copehagen University, Faculty of Health Sciences, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427115
- Sponsor's protocol ID
- 01-173/04
- Status last verified
- May 2008
- First submitted
- 25 Jan 2007
- Last updated
- 21 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Exercise an Psycho-Educational Intervention During Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00427115
- Acronym / sponsor ID
- 01-173/04
- Conditions
- Allogeneic Stem Cell Transplantation, Leukemia
- Keywords
- Patients undergoing allogeneic stem cell transplantations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 26 Jan 2007 (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.
Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise - psycho-educational intervention in patients undergoing allogeneic stem cell transplantation (allo-HCST). The intervention included structured and supervised exercise, relaxation and psycho-educational components. It was hypothesized that the intervention would minimize loss of physical capacity during hospitalization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 yrs
- patients undergoing allogeneic stem cell transplantation
Key exclusion criteria (5 listed)
- recent cardiovascular or pulmonary disease
- abnormal EKG
- psychiatric disorder
- motor function, musculoskeletal or neurological disturbances
- bony metastasis
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 |
|---|---|---|
| Multimodal exercise and psychosocial program | Behavioural | – |
Primary outcome
Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test
Time frame: Baseline, post
2 secondary outcomes
quality of life indices
Time frame: baseline, post, 3 and 6 months
FACT-An, EORTC, HADS, Mini-Mac, Symptom Assessment form
Time frame: baseline, post, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2008.
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ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Acute Myeloid Leukemia
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A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
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CAR T-cell Therapy Targeting CD19 and BCMA in Patients With AIHA Who Have Failed ≥3 Lines of Therapy.
Autoimmune Hemolytic Anemia, CD19/BCMA CAR T-cells
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Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia
Acute Lymphobkastic Leukemia, Adult
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.
Mary E Jarden, MSN PhD stud principal investigator
Copenhagen University Hospital, Denmark
Lis Adamsen, ProfessorPhD study chair
Copehagen University, Faculty of Health Sciences, Denmark
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 Multimodal exercise and psychosocial program in people with Allogeneic Stem Cell Transplantation and Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 21 May 2008. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test (time frame: Baseline, post). 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 May 2008.