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

This study has been completed.
Sponsor:
Collaborators:
Novo Nordisk
Lundbeck Foundation
Information provided by (Responsible Party):
Mary Jarden, Universitetshospitalernes Center for Sygepleje
ClinicalTrials.gov Identifier:
NCT01557686
First received: March 15, 2012
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Acute Leukemia
 Behavioral: Health counseling and exercise
 Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitetshospitalernes Center for Sygepleje:

Primary Outcome Measures:
  • Feasibility - adherence rates [ Time Frame: Adherence to the intervention components from baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    Percentage of intervention participation


Secondary Outcome Measures:
  • Adverse events [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    Number and type of adverse events

  • 6MWD [ Time Frame: Change from baseline in 6MWD at 6 weeks ] [ Designated as safety issue: Yes ]
    Change in distance in meter

  • Attrition [ Time Frame: Withdrawal from the project from baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    Number of patients that withdrew from the project

  • Timed chair stand [ Time Frame: Change from baseline in timed chair stand at 6 weeks ] [ Designated as safety issue: Yes ]
    Change in the number of repetitions

  • Timed bicep curl [ Time Frame: Change from baseline in timed bicep curl at 6 weeks ] [ Designated as safety issue: Yes ]
    Change in number of repetitions

  • FACT-Anemia [ Time Frame: Change from baseline in FACT-An at 6 weeks ] [ Designated as safety issue: No ]
    Change in scores for quality of life/function

  • HADS [ Time Frame: Change from baseline in HADS at 6 weeks ] [ Designated as safety issue: No ]
    Change in scores for emotional wellbeing

  • SF36 [ Time Frame: Change from baseline in SF36 at 6 weeks ] [ Designated as safety issue: No ]
    Change in scores for general health

  • MDSAI [ Time Frame: Change from baseline over time (1,2,3,4,5,6 weeks) ] [ Designated as safety issue: No ]
    Change in scores for symptom burden


Enrollment: 20
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557686

Locations
Denmark
Copenhagen University Hospital
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Sponsors and Collaborators
Universitetshospitalernes Center for Sygepleje
Novo Nordisk
Lundbeck Foundation
Investigators
Principal Investigator: Mary Jarden, Ph.D. Copenhagen University Hospital
  More Information

No publications provided

Responsible Party: Mary Jarden, Research Fellow, Universitetshospitalernes Center for Sygepleje
ClinicalTrials.gov Identifier: NCT01557686     History of Changes
Other Study ID Numbers: H-4-2010-046 Pilot
Study First Received: March 15, 2012
Last Updated: March 16, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on June 18, 2013