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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.
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 models.
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 population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | After obtaining daily medical clearance, patients will be approached 4-5 days per week to perform 30-45 minutes of supervised exercise with a Canadian Society for Exercise Physiology (CSEP) - Certified Exercise Physiologist. All exercise sessions will be as tolerated, based on patient symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Aerobic Capacity (VO2peak) | 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. | Baseline, Post-induction (weeks 4-6) |
| 6-minute Walk Test | Measure of functional endurance assessed by the walking distance covered in a 6-minute period. Participants walk a pre-established course for a total of 6 minutes. The distance covered in that time is recorded as the 6-minute walk test score. | Baseline, Post-induction (4-6 weeks) |
| Timed 10-chair Stands | Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible. | Baseline, Post-induction (weeks 4-6) |
| Grip Strength | Measure of upper-body strength using a Jamar hand dynamometer. Participants were asked to hold and squeeze (the dynamometer) with maximal force. Three trials were completed with each hand, alternating between the right and left to minimize fatigue. The highest recorded value of the dominant hand was used in the analysis. | Baseline, Post-induction (weeks 4-6) |
| Recruitment Rate | Ratio of patients who consented to participate out of all eligible patients expressed as a percentage (eligible patients who consented to participation/eligible patients who declined participation). |
| Measure | Description | Time Frame |
|---|---|---|
| Global Quality of Life | Global quality of life (QOL) will be measured by the European Organization for the Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30). The EORTC QLQ-C30 is a widely used, self-reported, psychometrically sound cancer QOL instrument. QOL scores derived from this questionnaire range from 0-100 with a higher score reflecting a higher QOL. | Baseline, Post-induction (weeks 4-6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shabbir MH Alibhai, MD, MSc | University Health Network, Toronto Rehab Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22726923 | Derived | Alibhai SM, O'Neill S, Fisher-Schlombs K, Breunis H, Brandwein JM, Timilshina N, Tomlinson GA, Klepin HD, Culos-Reed SN. A clinical trial of supervised exercise for adult inpatients with acute myeloid leukemia (AML) undergoing induction chemotherapy. Leuk Res. 2012 Oct;36(10):1255-61. doi: 10.1016/j.leukres.2012.05.016. Epub 2012 Jun 21. |
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This non-randomized phase II study recruited patients between June 2010 and February 2011. All participants were recruited from Princess Margaret Hospital (PMH) in Toronto, Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Aerobic Capacity (VO2peak) | 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. | Posted | Mean | Standard Deviation | metabolic equivalent (METS) | Baseline, Post-induction (weeks 4-6) |
|
Adverse event data were captured over the course of the intervention (9 months).
Any adverse events were captured using the National Cancer Institute: Cancer Therapy Evaluation Program Common Terminology Criteria version 3.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Possible grade II musculoskeletal event | Musculoskeletal and connective tissue disorders | NCI CTC v3.0 | Systematic Assessment | In over 600 patient-days of observation, one possible grade II musculoskeletal event occurred (neck/back pain limiting function for 24 hours). No other adverse events or safety concerns were reported. |
Although as per study design, limitations include the lack of a control group due to non-randomization, a small sample size and lack of generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara O'Neill | University Health Network | 416-597-3422 | 7860 | o'neill.sara@torontorehab.on.ca |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
|
| Baseline |
| Retention | Percentage of participants who remained in the study (did not withdraw voluntarily). | Baseline, Post-induction (weeks 4-6) |
| Program Adherence. | Adherence to supervised exercise program assessed as a percentage of exercise sessions completed(number of days of supervised exercise performed/the number of days that patients were approached to participate). | Baseline, Post-induction (weeks 4-6) |
| Fatigue | Fatigue will be assessed using the Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). The FACT-Fatigue consists of 13 questions and has excellent psychometric characteristics. Fatigue scores derived from this questionnaire range from 0-52 with a higher score reflecting lower fatigue. | Baseline, Post-induction (weeks 4-6) |
| Length of Stay | Length of stay (date of admission to hospital to date of discharge). | Post-induction (weeks 4-6) |
| Intensive Care Unit (ICU) Admission | Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course). | Post-induction (weeks 4-6) |
| Development of Sepsis | Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course). | Post-induction (weeks 4-6) |
| Refused |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | 6-minute Walk Test | Measure of functional endurance assessed by the walking distance covered in a 6-minute period. Participants walk a pre-established course for a total of 6 minutes. The distance covered in that time is recorded as the 6-minute walk test score. | Posted | Mean | Standard Deviation | feet | Baseline, Post-induction (4-6 weeks) |
|
|
|
| Primary | Timed 10-chair Stands | Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible. | Posted | Mean | Standard Deviation | seconds | Baseline, Post-induction (weeks 4-6) |
|
|
|
| Primary | Grip Strength | Measure of upper-body strength using a Jamar hand dynamometer. Participants were asked to hold and squeeze (the dynamometer) with maximal force. Three trials were completed with each hand, alternating between the right and left to minimize fatigue. The highest recorded value of the dominant hand was used in the analysis. | Posted | Mean | Standard Deviation | kilograms | Baseline, Post-induction (weeks 4-6) |
|
|
|
| Secondary | Global Quality of Life | Global quality of life (QOL) will be measured by the European Organization for the Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30). The EORTC QLQ-C30 is a widely used, self-reported, psychometrically sound cancer QOL instrument. QOL scores derived from this questionnaire range from 0-100 with a higher score reflecting a higher QOL. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-induction (weeks 4-6) |
|
|
|
| Secondary | Fatigue | Fatigue will be assessed using the Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). The FACT-Fatigue consists of 13 questions and has excellent psychometric characteristics. Fatigue scores derived from this questionnaire range from 0-52 with a higher score reflecting lower fatigue. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-induction (weeks 4-6) |
|
|
|
| Secondary | Length of Stay | Length of stay (date of admission to hospital to date of discharge). | Posted | Mean | Standard Deviation | days | Post-induction (weeks 4-6) |
|
|
|
| Secondary | Intensive Care Unit (ICU) Admission | Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course). | Posted | Number | percentage of participants | Post-induction (weeks 4-6) |
|
|
|
| Secondary | Development of Sepsis | Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course). | Posted | Number | percentage of participants | Post-induction (weeks 4-6) |
|
|
|
| Primary | Recruitment Rate | Ratio of patients who consented to participate out of all eligible patients expressed as a percentage (eligible patients who consented to participation/eligible patients who declined participation). | For this outcome measure we analyzed 52 participants (rather than 35). Fifty-two participants met the study eligibility criteria. Thirty-five out of 52 consented to participate which is how we derived our recruitment rate of 67% (35/52). | Posted | Number | percentage of patients | Baseline |
|
|
|
| Primary | Retention | Percentage of participants who remained in the study (did not withdraw voluntarily). | Posted | Number | percentage of participants | Baseline, Post-induction (weeks 4-6) |
|
|
|
| Primary | Program Adherence. | Adherence to supervised exercise program assessed as a percentage of exercise sessions completed(number of days of supervised exercise performed/the number of days that patients were approached to participate). | Posted | Number | percentage of exercise days completed | Baseline, Post-induction (weeks 4-6) |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001519 | Behavior |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |