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Completed

NCT Number: NCT01404520

Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)

The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.

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Key information

Conditions

Acute Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital Rigshospital, 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 cardial disease
  • Documented bone metastasis
  • Cognitively or emotionally unstable
  • Unable to read or write in Danish
  • Patients unable to carry out baseline tests

Treatment and study plan

Exercise based multimodal intervention

Other

The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 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 health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme.

Primary outcomes

  1. Six Minute Walk Distance 6MWD

    Time frame: Change from baseline in 6MWD at 12 weeks

    Change in distance in meter

Secondary outcomes

  1. Estimated VO2 max Aastrand test

    Time frame: Change from baseline in VO2 Aastrand test at 12 weeks

    Change in l/m

  2. Timed chair stand

    Time frame: Change from baseline in timed chair stand at 12 weeks

    Change in number of repetitions

  3. Timed biceps curl

    Time frame: Change from baseline in timed bicep curl at 12 weeks

    Change in number of repetitions

  4. EORTC QLQ-C30

    Time frame: Change from baseline in EORTC QLQ-C30 at 12 weeks

    Change in scores for quality of life

  5. FACT-An

    Time frame: Change from baseline in FACT-An at 12 weeks

    Change in scores for quality of life/function

  6. HADS

    Time frame: Change from baseline in HADS at 12 weeks

    Change in scores for emotional wellbeing

  7. SF36

    Time frame: Change from baseline in SF36 at 12 weeks

    Change in scores for general health

  8. MDASI

    Time frame: Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks)

    Change in scores for symptom burden

Sponsors and collaborators

Lead sponsor

Universitetshospitalernes Center for Sygepleje

Other

Collaborators

  • Danish Cancer Society
  • Lundbeck Foundation
  • Novo Nordisk A/S
  • University of Copenhagen

Registry information

Official study title

Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy

Acronym: PACE-AL

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jul 28, 2011
Registry last updated
Dec 2, 2015

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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