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

Acute Leukemia Clinical Trial

— PACE-AL  

Official title:

Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557686
• Other study ID #: H-4-2010-046 Pilot
• Status: Completed
• Phase: Phase 0
• First received: March 15, 2012
• Last updated: March 16, 2012
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2012
• Source: Universitetshospitalernes Center for Sygepleje
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

Behavioral:
• Health counseling and exercise
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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital	Copenhagen
Denmark	Herlev Hospital	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Universitetshospitalernes Center for Sygepleje	Lundbeck Foundation, Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - adherence rates	Percentage of intervention participation	Adherence to the intervention components from baseline to 6 weeks	Yes
Secondary	Adverse events	Number and type of adverse events	baseline to 6 weeks	Yes
Secondary	6MWD	Change in distance in meter	Change from baseline in 6MWD at 6 weeks	Yes
Secondary	Attrition	Number of patients that withdrew from the project	Withdrawal from the project from baseline to 6 weeks	Yes
Secondary	Timed chair stand	Change in the number of repetitions	Change from baseline in timed chair stand at 6 weeks	Yes
Secondary	Timed bicep curl	Change in number of repetitions	Change from baseline in timed bicep curl at 6 weeks	Yes
Secondary	FACT-Anemia	Change in scores for quality of life/function	Change from baseline in FACT-An at 6 weeks	No
Secondary	HADS	Change in scores for emotional wellbeing	Change from baseline in HADS at 6 weeks	No
Secondary	SF36	Change in scores for general health	Change from baseline in SF36 at 6 weeks	No
Secondary	MDSAI	Change in scores for symptom burden	Change from baseline over time (1,2,3,4,5,6 weeks)	No