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Completed

NCT Number: NCT01557686

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

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.

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Key information

Conditions

Acute Leukemia Behavior Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Copenhagen University Hospital, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health counseling and exercise

Behavioral

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 outcomes

  1. Feasibility - adherence rates

    Time frame: Adherence to the intervention components from baseline to 6 weeks

    Percentage of intervention participation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitetshospitalernes Center for Sygepleje

Other

Collaborators

  • Lundbeck Foundation
  • Novo Nordisk A/S

Registry information

Official study title

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

Acronym: PACE-AL

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 19, 2012
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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