Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)
NCT ID: NCT01404520
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2011-06-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Exercise based multimodal intervention
The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme
Exercise based multimodal intervention
The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme.
Control Group
Control group receives usual care
No interventions assigned to this group
Interventions
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Exercise based multimodal intervention
The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme.
Eligibility Criteria
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Inclusion Criteria
* Normal EKG, blood pressure and pulse
* Signed informed written consent
Exclusion Criteria
* Patients diagnosed with a symptomatic cardial disease
* Documented bone metastasis
* Cognitively or emotionally unstable
* Unable to read or write in Danish
* Patients unable to carry out baseline tests
18 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Novo Nordisk A/S
INDUSTRY
Danish Cancer Society
OTHER
Lundbeck Foundation
OTHER
Universitetshospitalernes Center for Sygepleje
OTHER
Responsible Party
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Mary Jarden
Research Fellow
Principal Investigators
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Mary Jarden, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UCSF and CIRE
Locations
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Copenhagen University Hospital Rigshospital
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Countries
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References
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Jarden M, Moller T, Christensen KB, Kjeldsen L, Birgens HS, Adamsen L. Multimodal intervention integrated into the clinical management of acute leukemia improves physical function and quality of life during consolidation chemotherapy: a randomized trial 'PACE-AL'. Haematologica. 2016 Jul;101(7):e316-9. doi: 10.3324/haematol.2015.140152. Epub 2016 Apr 1. No abstract available.
Jarden M, Moller T, Kjeldsen L, Birgens H, Christensen JF, Bang Christensen K, Diderichsen F, Hendriksen C, Adamsen L. Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL)--a randomized controlled trial. BMC Cancer. 2013 Oct 2;13:446. doi: 10.1186/1471-2407-13-446.
Other Identifiers
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H-4-2010-046
Identifier Type: -
Identifier Source: org_study_id