Clinical trial NCT00764231: A Study of a Home-based Exercise Intervention for Patients With Acute Myeloid Leukaemia (AML)
Official title: A Pilot Study of a Home-based Exercise Intervention for Patients With AML
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Exercise
Fatigue
Quality of Life
Keywords: acute myeloid leukemia
exercise
fatigue
quality of life
home-based
AML
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: The Leukemia and Lymphoma Society
First posted: 2008-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Background: Fatigue is the most common and disabling symptom affecting patients with acute myeloid leukaemia (AML). Fatigue is negatively associated with quality of life (QOL) and daily function, and remains a major problem for patients even 6 months after completion of treatment (12 months after diagnosis). Despite this, there have been no intervention studies to reduce fatigue and improve QOL in AML. In a number of studies done in mostly younger patients with solid tumours, exercise has been shown to improve fatigue and QOL. Because of important differences between older patients with AML and younger patients with solid tumours, a randomized trial needs to be performed in this population. Prior to embarking on a definitive study, a pilot study is needed to ensure feasibility, to estimate recruitment rates, and to demonstrate if exercise is effective in reducing fatigue in older patients with AML.

Objectives: (1) To determine the feasibility of recruitment to, and patient adherence with, a 12-week home-based exercise intervention study among patients age 40 or older with AML in complete remission. (2) To provide estimates of the effects of exercise on fatigue and QOL to facilitate the design of a RCT. (3) To examine the relationship between exercise adherence, improvements in fitness, fatigue, and QOL in AML patients undergoing a home-based exercise intervention.

Methods: Patients age 40 or older with AML who have completed chemotherapy and achieved complete remission are eligible for the study. Patients will be recruited at the Princess Margaret Hospital, Canada's largest AML referral centre. Fitness and QOL measures will be assessed at baseline, half-way through the intervention, at the end of the 12-week exercise intervention, and 12 weeks later. Patients will be randomized to the intervention arm or a wait-list control. The intervention consists of a structured, personalized, 12-week home-based exercise program that is theory-based and modelled after a successful program in patients with another malignancy. A certified fitness instructor will lead the intervention. Patients in the wait-list control group will be asked to maintain usual level of activity for 12 weeks, after which they will be crossed over to the intervention arm to receive an identical intervention. Fitness measures include anthropometric measures, the 6-minute walk test, grip strength, and a measure of flexibility. The primary outcome measure is fatigue, which will be measured with the FACT Fatigue subscale. QOL will be assessed with the EORTC QLQ-C30. Weekly telephone assessments and 5 in-clinic assessments over the duration of the program will be done to measure program adherence. The investigators plan to approach 100 patients over a 12-month period and anticipate recruiting 40 patients. A detailed recruitment log will be maintained. Mixed effects linear regression models will be used to measure the effect of the intervention on fatigue and QOL. Relationships between changes in fitness level will be regressed with changes in fatigue and QOL in a secondary analysis. The impact of exercise adherence on outcomes will also be assessed.

Significance: Despite the importance of fatigue in patients with AML, its treatment remains poorly understood.The investigators plan to evaluate the most promising intervention, exercise, in a pilot study. The results of our study will be crucial to the design of a definitive multi-centre randomized trial to lessen fatigue and improve overall QOL in middle-aged and older patients with AML.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Another active malignancy
* Life expectancy \< 3 months
* Severe or unstable cardiorespiratory disease
* Bone marrow transplant candidates

Primary outcomes:
measure: Quality of life (fatigue, global health)
timeFrame: 12 weeks
Secondary outcomes:
measure: Recruitment rate
timeFrame: 12 weeks
measure: Adherence rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Shabbir MH Alibhai, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: