A Study of a Home-based Exercise Intervention for Patients With Acute Myeloid Leukaemia (AML)
A Pilot Study of a Home-based Exercise Intervention for Patients With AML
1 other identifier
interventional
40
1 country
1
Brief Summary
Fatigue is the most common and disabling symptom in acute myeloid leukaemia (AML). Studies in other cancer patients with fatigue have shown that exercise improves both fatigue and quality of life (QOL), but there are no such studies in AML. The investigators want to conduct a pilot study of a home-based exercise program to see if this type of exercise program is feasible for AML patients, reduces fatigue, and improves QOL. What the investigators learn from this study will be essential to designing a larger, definitive randomized trial of exercise in patients with AML.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 1, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFebruary 8, 2012
February 1, 2012
2.3 years
September 30, 2008
February 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life (fatigue, global health)
12 weeks
Secondary Outcomes (2)
Recruitment rate
12 weeks
Adherence rate
12 weeks
Study Arms (2)
Exercise
EXPERIMENTALThis group will undergo a 12-week home-based exercise intervention with follow-up fitness assessments.
Wait list control
OTHERThis group will go on a 12-week wait list, during which time they will be asked not to change their exercise habits. After 12 weeks, this group will participate in the exercise intervention.
Interventions
Subjects will be given a personalized 12-week exercise program consisting of cardiovascular, musculoskeletal and flexibility exercises by a certified exercise physiologist. They will receive fitness assessments at baseline, 6 weeks and 12 weeks.
Subjects will have a 12-week waiting period, during which time they will be asked not to change their exercise habits. These subjects will receive the same fitness assessments as the experimental group (baseline, 6 weeks, 12 weeks), but will not receive an exercise program during the wait-list period. Following the 12-week wait-list period, subjects will be given the same home-based exercise intervention as the experimental group.
Eligibility Criteria
You may qualify if:
- Completion of induction and consolidation chemotherapy
- AML with histologically confirmed complete remission
- Fluency in English (or availability of bilingual caregiver and fluency in language for which validated translations of the FACT-Fatigue exist)
- Potential participants must also be screened with the Physical Activity Readiness Questionnaire (PAR-Q \& PAR-MedX) and receive physician approval to participate in an exercise program
You may not qualify if:
- Another active malignancy
- Life expectancy \< 3 months
- Severe or unstable cardiorespiratory disease
- Bone marrow transplant candidates
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Toronto Rehabilitation Institutelead
- University Health Network, Torontocollaborator
- The Leukemia and Lymphoma Societycollaborator
Study Sites (1)
Princess Margaret Hospital
Toronto, Ontario, M5G 1Z5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shabbir MH Alibhai, MD, MSc
University Health Network, Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician and Senior Scientist
Study Record Dates
First Submitted
September 30, 2008
First Posted
October 1, 2008
Study Start
October 1, 2008
Primary Completion
February 1, 2011
Study Completion
April 1, 2011
Last Updated
February 8, 2012
Record last verified: 2012-02