A Study of a Home-based Exercise Intervention for Patients With Acute Myeloid Leukaemia (AML)

February 7, 2012 updated by: Shabbir Alibhai, Toronto Rehabilitation Institute

A Pilot Study of a Home-based Exercise Intervention for Patients With AML

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
This group will undergo a 12-week home-based exercise intervention with follow-up fitness assessments.
Behavioral: Home-based exercise program
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.
Other Names:
  • exercise
  • fitness
Other: Wait list control
This 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.
Behavioral: Wait list
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.
Other Names:
  • exercise
  • fitness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life (fatigue, global health)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Recruitment rate
Time Frame: 12 weeks
12 weeks
Adherence rate
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toronto Rehabilitation Institute

Collaborators

University Health Network, Toronto
The Leukemia and Lymphoma Society

Investigators

  • Principal Investigator: Shabbir MH Alibhai, MD, MSc, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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