Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study

Early Phase 1

Completed

• Conditions: Acute Leukemia

• Registration Number: NCT01557686
• Lead Sponsor: Universitetshospitalernes Center for Sygepleje

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-03
• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-16
• Last Update Submitted: 2012-03-16
• Study First Posted: 2012-03-19
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility - adherence rates	Adherence to the intervention components from baseline to 6 weeks	Percentage of intervention participation

Secondary Outcome Measures

Name	Time	Method
Adverse events	baseline to 6 weeks	Number and type of adverse events
6MWD	Change from baseline in 6MWD at 6 weeks	Change in distance in meter
Attrition	Withdrawal from the project from baseline to 6 weeks	Number of patients that withdrew from the project
Timed chair stand	Change from baseline in timed chair stand at 6 weeks	Change in the number of repetitions
Timed bicep curl	Change from baseline in timed bicep curl at 6 weeks	Change in number of repetitions
FACT-Anemia	Change from baseline in FACT-An at 6 weeks	Change in scores for quality of life/function
HADS	Change from baseline in HADS at 6 weeks	Change in scores for emotional wellbeing
SF36	Change from baseline in SF36 at 6 weeks	Change in scores for general health
MDSAI	Change from baseline over time (1,2,3,4,5,6 weeks)	Change in scores for symptom burden

Trial Locations

Locations (2)

Herlev Hospital; 🇩🇰 Herlev, Denmark

Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark