Clinical trial · Interventional
Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)
Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise based multimodal intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise based multimodal intervention
- description
- 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
- interventionNames
- Other: Exercise based multimodal intervention
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Control group receives usual care
Primary outcomes (1)
- measure
- Six Minute Walk Distance 6MWD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients that are able to speak Danish \> 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL) * Normal EKG, blood pressure and pulse * Signed informed written consent Exclusion Criteria: * Medical reason that contraindicates physical activity * 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
References
Publications (2)
- DERIVEDJarden 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. PMID 27036163
- DERIVEDJarden 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. PMID 24083543