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A Pilot Exercise RCT for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy: Pre-randomization Phase

Phase 2
18 Years
Not Enrolling
Acute Myeloid Leukemia

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Trial Information

A Pilot Exercise RCT for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy: Pre-randomization Phase

Background: Acute myeloid leukaemia (AML) is a life-threatening haematological malignancy.
Initial treatment with induction chemotherapy requires 4-5 weeks of hospitalization, with a
risk of physical deconditioning, declines in quality of life (QOL), and significant fatigue.
Four pilot exercise studies have demonstrated improved fitness, strength, QOL, and fatigue
in patients undergoing induction, but are limited by small sample sizes, recruitment of
mostly younger adults, inconsistent endpoints, and design issues. Prior to conducting a
large multi-centre randomized controlled trial (RCT), important pilot work first needs to be
done to demonstrate feasibility of a randomized trial of an exercise program in AML patients
undergoing induction chemotherapy; to ensure safety; and to provide effect estimates of the
intervention on fitness and QOL/fatigue endpoints.

Objectives: Primary objectives are: (1) to determine feasibility of recruitment and
retention of adult AML patients to a randomized trial of supervised exercise and ability of
patients to perform an exercise intervention in hospital; (2) to provide estimates of the
effect of exercise on fitness parameters. Secondary objectives are: (1) to determine
effects of exercise on QOL and fatigue; (2) to understand the impact of exercise on AML
treatment tolerability; (3) to examine safety of the exercise intervention. Methods:
Thirty-five patients age 18 or older with newly diagnosed or relapsed AML who are undergoing
induction chemotherapy will be recruited at Princess Margaret Hospital. Participants will
perform 30-45 minutes of supervised aerobic and resistance exercises 4-5 days per week.
Primary outcomes are recruitment rate, exercise adherence rate, and impact on fitness
measures (peak aerobic capacity (VO2peak), grip strength, leg strength, 6-minute walk test).
QOL will be measured with the European Organization for the Research and Treatment of
Cancer (EORTC) core 30-item questionnaire (QLQ-C30). Fatigue will be measured using the
Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). Treatment
tolerability outcomes include length of stay, intensive care unit admission, and the
development of sepsis. Outcomes over time will be assessed using mixed effects regression

Significance: Exercise is a promising intervention for improving fitness, QOL and treatment
tolerability in AML patients undergoing induction chemotherapy. This pilot RCT will
establish feasibility and safety, as well as provide efficacy estimates that will be vital
to the design and conduct of a definitive multi-centre RCT of exercise in this patient

Inclusion Criteria:

- at least 18 years old

- newly diagnosed AML, or relapsed AML after having been in complete remission for at
least 6 months

- initiating induction chemotherapy

- ambulatory without need for human assistance

- has consented to study

- is medically cleared for participation by attending physician

Exclusion Criteria:

- has another active malignancy

- has life expectancy < 1 month, physician determined

- has significant comorbidity

- has uncontrolled pain

- has haemodynamic instability

- lacks fluency in reading and writing English and there is no translator available for
each visit

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Peak Aerobic Capacity (VO2peak)

Outcome Description:

The modified Bruce protocol is a walking-based treadmill test used to assess peak aerobic capacity. As the test progresses the intensity of each 3-minute work load increases. The test concludes when the participant reaches his maximal heart rate or volitional fatigue. The value attained on this test is measured in metabolic equivalents (METS). METS are a measure of exercise intensity and reflect the physical demands of an activity. In this context, a higher value achieved on the treadmill test (in METS) indicates work at a higher intensity and therefore a higher aerobic capacity.

Outcome Time Frame:

Baseline, Post-induction (weeks 4-6)

Safety Issue:


Principal Investigator

Shabbir MH Alibhai, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto Rehab Institute


Canada: Ethics Review Committee

Study ID:




Start Date:

June 2010

Completion Date:

March 2011

Related Keywords:

  • Acute Myeloid Leukemia
  • acute myeloid leukemia
  • AML
  • chemotherapy
  • exercise
  • quality of life
  • cancer-related fatigue
  • elderly
  • physical fitness
  • muscular strength
  • Feasibility
  • Efficacy
  • Safety
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid