Aerobic and Strengthening Exercise for Acute Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      Survivors of childhood leukemia have muscle weakness and impaired mobility (physical
      performance), a higher than expected frequency of obesity, and early mortality from
      cardiovascular disease. Treatment related neuropathy, cardiotoxicity and general cachexia may
      complicate physical performance and establish a pattern of sedentary behavior that may lead
      to a lifetime of inactivity. There is limited evidence that children being treated for
      leukemia benefit from home exercise programs during the maintenance phase of therapy,
      particularly in terms of muscle strength and range of motion. However, there are no
      established guidelines regarding the prescription of exercise for children diagnosed with
      leukemia. We propose to test the feasibility of an exercise intervention among children being
      treated for acute lymphoblastic leukemia (ALL) and hypothesize that children who participate
      in the exercise intervention will demonstrate improvements in gross motor function, strength,
      flexibility, and cardio respiratory fitness, and that they will have more favorable body
      composition when compared to the children who are assigned to the usual activity group.
    

Detailed description: 
      The purpose of this trial is to determine the feasibility of an aerobic and strengthening
      exercise intervention trial among children during maintenance therapy for childhood ALL by
      evaluating participant accrual, participant compliance, and burden to the institutional
      staff.

      We anticipate that key barriers exist which threaten the successful completion of an
      interventional trial of exercise within the ALL patient population. Approximately 2,500 to
      3,500 children are diagnosed each year with ALL and similar numbers will enter the
      maintenance phase of therapy during a given year. About 22% of those diagnosed are between 5
      and 8 years old. Thus accrual is limited by the small patient population but fortunately most
      patients with ALL receive their care at dedicated pediatric oncology institutions. Lack of
      interest or lack of understanding of the underlying problem of obesity and weakness among
      survivors in the ALL population may be additional barriers to accrual. In addition, families
      may be overwhelmed by the primary diagnosis of leukemia and feel that they are unable to take
      on additional challenges.

      Compliance to a rigorous exercise regimen must be ascertained if demonstrable improvement in
      motor performance, body composition and cardiovascular disease risk profile are to occur. Key
      to this study is not only short-term compliance but designing an intervention that will
      promote and improve long-term rates of exercise. Barriers to compliance include length of
      time to complete the intervention, number of days the intervention must be administered,
      perceived benefit by the participant, difficulty of the intervention, inadequate
      demonstration of the intervention, poor understanding by the participant/parent of the
      importance of obesity and weakness among survivors of childhood ALL, and health issues in
      regard to the primary diagnosis of ALL.

      We will open a feasibility study at 3 institutions dedicated to treatment of childhood
      cancer: St. Jude Children's Research Hospital, Oregon Health & Science University and
      Vanderbilt Ingram Cancer Center .The accrual goal of this study will be a total of 20
      patients. The hypothesized outcome for this aim of the feasibility study will be an accrual
      rate of 50% of eligible patients at a given institution.

      Motor Function The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be
      used to measure participants' motor function. Maximum isometric knee extension strength will
      be measured with a hand held myometer and hand grip strength will be measured with a hand
      held dynamometer. Additionally, flexibility will be measured with the sit and reach test.
      Ankle dorsiflexion active and passive range of motion will be measures with a goniometer.
      Aerobic capacity will be measured with the modified Cooper 6 minute walk test. Body
      composition and vital signs will also be collected.

      Intervention Participants will receive counseling and written material regarding the benefits
      of exercise and an individualized exercise instruction session based on the results of their
      baseline testing and their individual preferences. Each program will include ability specific
      stretching/flexibility, progressive resistive strengthening, and aerobic exercise. Necessary
      equipment for the strengthening (weights, stretch cords, elastic bands) and aerobic
      components will also be provided. A videotape demonstrating each exercise in the intervention
      will be given to the participant and their parent."

      Detailed written instructions, along with a book to log exercise, will also be provided.
      Stickers and small toys will be provided for the parents to give to their children for
      completing their exercises. Participants will receive a weekly phone call from an exercise
      coach, to answer questions and to progress the intervention. Participants will also receive
      counseling and review/progression of the exercise intervention at each usual clinic visit
      (approximately monthly). During the pilot study, participants will continue to receive the
      intervention for six months, with weekly phone calls tapering to every other week after three
      months. The exercise coach will be available to the participant/parent as needed via phone
      and/or email throughout the intervention period.
    

Intervention name(s): Gross Motor Function; Knee extension strength; Hand grip strength; Flexibility; Ankle range of motion; Aerobic capacity; Body composition and vital signs
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be used to measure participants' motor function. The test is norm- referenced and designed to test motor function in children and adolescents 4 -21 years of age. The motor composite score describes overall motor abilities and is comprised of fine motor control, manual coordination, body coordination, and strength and agility. We will use the total motor composite to describe overall motor function.; Maximum isometric knee extension strength will be measured with the subject seated in an adjustable straight-back chair. The pelvis will be fixed by an adjustable strap and the knee flexed to 45 degrees. The participant will exert a maximal voluntary force until their contraction is "broken."; Hand grip strength in kilograms will be measured using a Jamar hand held dynamometer (Sammons Preston Rolyan, Nottinghamshire, UK). Participants will be seated with the shoulder at 0-10 degrees and the elbow in 90 degrees of flexion. The forearm will be positioned in neutral. Each participant will complete three trials, and the average used for analysis.; Flexibility will be measured by having the participant perform the sit and reach test. A yardstick is placed on a firm flat surface and tape is placed across it at a right angle to the 15 inch mark. The participant sits with the yardstick between the legs with legs extended at right angles to the taped line on the floor. The heels of the feet touch the edge of the taped line and are 10-12 inches apart. The participant reaches forward with both hands as far as possible, keeping the hands parallel. The best value for three trials, in centimeters, at the most distant point of the fingertips is recorded.; Ankle dorsiflexion active and passive range of motion will be measured with a goniometer. The goniometer is a reliable and valid measure of active and passive range of motion if the rater uses standard procedures; Participants will complete the modified Cooper test where they walk in a corridor as fast as possible for six minutes. The distance is recorded in meters and can also be used to estimate peak V02; Height, body mass index, waist circumference, and blood pressure will be measured.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care