NCT01557686
Completed
Early Phase 1
Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial
Universitetshospitalernes Center for Sygepleje2 sites in 1 country20 target enrollmentMay 2010
ConditionsAcute Leukemia
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Acute Leukemia
- Sponsor
- Universitetshospitalernes Center for Sygepleje
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Feasibility - adherence rates
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Mary Jarden
Research Fellow
Universitetshospitalernes Center for Sygepleje
Eligibility Criteria
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
Outcomes
Primary Outcomes
Feasibility - adherence rates
Time Frame: Adherence to the intervention components from baseline to 6 weeks
Percentage of intervention participation
Secondary Outcomes
- Adverse events(baseline to 6 weeks)
- 6MWD(Change from baseline in 6MWD at 6 weeks)
- Attrition(Withdrawal from the project from baseline to 6 weeks)
- Timed chair stand(Change from baseline in timed chair stand at 6 weeks)
- Timed bicep curl(Change from baseline in timed bicep curl at 6 weeks)
- FACT-Anemia(Change from baseline in FACT-An at 6 weeks)
- HADS(Change from baseline in HADS at 6 weeks)
- SF36(Change from baseline in SF36 at 6 weeks)
- MDSAI(Change from baseline over time (1,2,3,4,5,6 weeks))
Study Sites (2)
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