Trial Outcomes & Findings for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy (NCT NCT01170598)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Baseline, Post-induction (weeks 4-6)

Results posted on

2012-04-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	35
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1
Overall Study Death	3
Overall Study Lost to Follow-up	1
Overall Study Refused	1

Baseline Characteristics

Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise n=35 Participants 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.
Age, Customized <60 years	18 years n=5 Participants
Age, Customized >=60 years	17 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Post-induction (weeks 4-6)

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 measures

Outcome measures
Measure	Exercise n=35 Participants 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.
Peak Aerobic Capacity (VO2peak) Baseline	6.9 metabolic equivalent (METS) Standard Deviation 1.8
Peak Aerobic Capacity (VO2peak) Post-induction (weeks 4-6)	7.4 metabolic equivalent (METS) Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline, Post-induction (4-6 weeks)

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.

Outcome measures

Outcome measures
Measure	Exercise n=35 Participants 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.
6-minute Walk Test Baseline	962.5 feet Standard Deviation 286.3
6-minute Walk Test Post-induction (weeks 4-6)	1176.2 feet Standard Deviation 360.6

PRIMARY outcome

Timeframe: Baseline, Post-induction (weeks 4-6)

Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible.

Outcome measures

Outcome measures
Measure	Exercise n=35 Participants 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.
Timed 10-chair Stands Baseline	33.0 seconds Standard Deviation 26.0
Timed 10-chair Stands Post-induction (weeks 4-6)	31.1 seconds Standard Deviation 11.2

PRIMARY outcome

Timeframe: Baseline, Post-induction (weeks 4-6)

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.

Outcome measures

Outcome measures
Measure	Exercise n=35 Participants 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.
Grip Strength Baseline	23.9 kilograms Standard Deviation 11.0
Grip Strength Post-induction (weeks 4-6)	21.6 kilograms Standard Deviation 11.0

PRIMARY outcome

Timeframe: Baseline

Population: 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).

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).

Outcome measures

Outcome measures
Measure	Exercise n=52 Participants 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.
Recruitment Rate	67 percentage of patients

PRIMARY outcome

Timeframe: Baseline, Post-induction (weeks 4-6)

Percentage of participants who remained in the study (did not withdraw voluntarily).

Outcome measures

Outcome measures
Measure	Exercise n=35 Participants 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.
Retention	97 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Post-induction (weeks 4-6)

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).

Outcome measures

Outcome measures
Measure	Exercise n=34 Participants 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.
Program Adherence.	45.8 percentage of exercise days completed

SECONDARY outcome

Timeframe: Baseline, Post-induction (weeks 4-6)

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.

Outcome measures

Outcome measures
Measure	Exercise n=34 Participants 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.
Global Quality of Life Baseline	45.1 units on a scale Standard Deviation 26.6
Global Quality of Life Post-induction (weeks 4-6)	51.4 units on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline, Post-induction (weeks 4-6)

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.

Outcome measures

Outcome measures
Measure	Exercise n=34 Participants 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.
Fatigue Baseline	31.5 units on a scale Standard Deviation 13.1
Fatigue Post-induction (weeks 4-6)	33.9 units on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: Post-induction (weeks 4-6)

Length of stay (date of admission to hospital to date of discharge).

Outcome measures

Outcome measures
Measure	Exercise n=34 Participants 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.
Length of Stay	37.2 days Standard Deviation 10.6

SECONDARY outcome

Timeframe: Post-induction (weeks 4-6)

Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course).

Outcome measures

Outcome measures
Measure	Exercise n=34 Participants 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.
Intensive Care Unit (ICU) Admission	11.5 percentage of participants

SECONDARY outcome

Timeframe: Post-induction (weeks 4-6)

Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course).

Outcome measures

Outcome measures
Measure	Exercise n=34 Participants 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.
Development of Sepsis	26.5 percentage of participants

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Exercise n=35 participants at risk 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.
Musculoskeletal and connective tissue disorders Possible grade II musculoskeletal event	2.9% 1/35 • Number of events 1 • 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.

Additional Information

Sara O'Neill

University Health Network

Phone: 416-597-3422

Email: o'[email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place