An Early Phase 1 interventional study of Health counseling and exercise in Acute Leukemia, sponsored by Universitetshospitalernes Center for Sygepleje. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-19.
Sponsored by Universitetshospitalernes Center for Sygepleje · Early Phase 1, Interventional, and Supportive care
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 20 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Universitetshospitalernes Center for Sygepleje is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention is initiated during chemotherapy treatment (consolidation) in the outpatient clinic and continues for 6 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 two health-promoting counseling sessions - Further, patients are fitted with a step counter pedometer.
Feasibility - adherence rates
Percentage of intervention participation
Time frame: Adherence to the intervention components from baseline to 6 weeks
Adverse events
Number and type of adverse events
Time frame: baseline to 6 weeks
6MWD
Change in distance in meter
Time frame: Change from baseline in 6MWD at 6 weeks
Attrition
Number of patients that withdrew from the project
Time frame: Withdrawal from the project from baseline to 6 weeks
Timed chair stand
Change in the number of repetitions
Time frame: Change from baseline in timed chair stand at 6 weeks
Timed bicep curl
Change in number of repetitions
Time frame: Change from baseline in timed bicep curl at 6 weeks
FACT-Anemia
Change in scores for quality of life/function
Time frame: Change from baseline in FACT-An at 6 weeks
HADS
Change in scores for emotional wellbeing
Time frame: Change from baseline in HADS at 6 weeks
SF36
Change in scores for general health
Time frame: Change from baseline in SF36 at 6 weeks
MDSAI
Change in scores for symptom burden
Time frame: Change from baseline over time (1,2,3,4,5,6 weeks)
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Universitetshospitalernes Center for Sygepleje