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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 A/S
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

March 15, 2012
March 16, 2012
May 2010
February 2011   (final data collection date for primary outcome measure)
Feasibility - adherence rates [ Time Frame: Adherence to the intervention components from baseline to 6 weeks ] [ Designated as safety issue: Yes ]
Percentage of intervention participation
Same as current
Complete list of historical versions of study NCT01557686 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study
Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial

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.

Not Provided
Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Acute Leukemia
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01557686
H-4-2010-046 Pilot
Yes
Mary Jarden, Universitetshospitalernes Center for Sygepleje
Universitetshospitalernes Center for Sygepleje
  • Novo Nordisk A/S
  • Lundbeck Foundation
Principal Investigator: Mary Jarden, Ph.D. Copenhagen University Hospital
Universitetshospitalernes Center for Sygepleje
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP