Phase 2
N=35
Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy
Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01170598 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Peak Aerobic Capacity (VO2peak) — 6.9; 7.4 metabolic equivalent (METS)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exercise (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Toronto Rehabilitation Institute
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Aerobic Capacity (VO2peak) |
6.9; 7.4 | — |
| PRIMARY 6-minute Walk Test |
962.5; 1176.2 | — |
| PRIMARY Timed 10-chair Stands |
33.0; 31.1 | — |
| PRIMARY Grip Strength |
23.9; 21.6 | — |
| PRIMARY Recruitment Rate |
67 | — |
| PRIMARY Retention |
97 | — |
| PRIMARY Program Adherence. |
45.8 | — |
| SECONDARY Global Quality of Life |
45.1; 51.4 | — |
| SECONDARY Fatigue |
31.5; 33.9 | — |
| SECONDARY Length of Stay |
37.2 | — |
| SECONDARY Intensive Care Unit (ICU) Admission |
11.5 | — |
| SECONDARY Development of Sepsis |
26.5 | — |
Summary
Fatigue, reduced quality of life and declines in physical function are common in patients undergoing chemotherapy for acute myeloid leukaemia (AML). Studies in other cancer patients undergoing treatment have shown that exercise improves these symptoms, but there are limited studies in AML. This study of a hospital-based exercise program will help determine if exercise is both feasible and helpful in improving symptoms among for AML patients undergoing chemotherapy.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01170598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.