Clinical trial · Interventional
Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study
Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial
NCT01557686CI-TRIAL-00006534PACE-ALcompletedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.
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 |
|---|---|---|---|
| Health counseling and exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Feasibility - adherence rates
- timeFrame
- Adherence to the intervention components from baseline to 6 weeks
- description
- Percentage of intervention participation
Secondary outcomes (9)
- measure
- Adverse events
- timeFrame
- baseline to 6 weeks
- description
- Number and type of adverse events
- measure
- 6MWD
- timeFrame
- Change from baseline in 6MWD at 6 weeks
- description
- Change in distance in meter
- measure
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 cardiac disease within the last three months. * Documented bone metastasis * Dementia, psychotic * Cannot write or read Danish * Patients unable to carry out baseline tests
References
Publications (0)
Data not yet available
No reference posted for this study.