Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study (PACE-AL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01557686
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : March 19, 2012
Novo Nordisk A/S
Lundbeck Foundation
Information provided by (Responsible Party):
Mary Jarden, 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.

Condition or disease Intervention/treatment Phase
Acute Leukemia Behavioral: Health counseling and exercise Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial
Study Start Date : May 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Feasibility - adherence rates [ Time Frame: Adherence to the intervention components from baseline to 6 weeks ]
    Percentage of intervention participation

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: baseline to 6 weeks ]
    Number and type of adverse events

  2. 6MWD [ Time Frame: Change from baseline in 6MWD at 6 weeks ]
    Change in distance in meter

  3. Attrition [ Time Frame: Withdrawal from the project from baseline to 6 weeks ]
    Number of patients that withdrew from the project

  4. Timed chair stand [ Time Frame: Change from baseline in timed chair stand at 6 weeks ]
    Change in the number of repetitions

  5. Timed bicep curl [ Time Frame: Change from baseline in timed bicep curl at 6 weeks ]
    Change in number of repetitions

  6. FACT-Anemia [ Time Frame: Change from baseline in FACT-An at 6 weeks ]
    Change in scores for quality of life/function

  7. HADS [ Time Frame: Change from baseline in HADS at 6 weeks ]
    Change in scores for emotional wellbeing

  8. SF36 [ Time Frame: Change from baseline in SF36 at 6 weeks ]
    Change in scores for general health

  9. MDSAI [ Time Frame: Change from baseline over time (1,2,3,4,5,6 weeks) ]
    Change in scores for symptom burden

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01557686

Copenhagen University Hospital
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Sponsors and Collaborators
Universitetshospitalernes Center for Sygepleje
Novo Nordisk A/S
Lundbeck Foundation
Principal Investigator: Mary Jarden, Ph.D. Copenhagen University Hospital

Responsible Party: Mary Jarden, Research Fellow, Universitetshospitalernes Center for Sygepleje Identifier: NCT01557686     History of Changes
Other Study ID Numbers: H-4-2010-046 Pilot
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012

Keywords provided by Mary Jarden, Universitetshospitalernes Center for Sygepleje:
Cancer Related fatigue
Quality of Life
Psychosocial Intervention
Physical Fitness
Physical Activity
Exercise Therapy
Leukemia, Myeloid, Acute
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Acute Leukemia

Additional relevant MeSH terms:
Acute Disease
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes