Individualized Exercise Programs for Patients Receiving Chemotherapy for Newly Diagnosed Acute or Relapsed Myeloid Leukemia or Lymphoblastic Leukemia

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 60 years
• All sexes
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: In-Hospital Individualized Prescriptive Exercise Intervention for Acute Leukemia Patients Undergoing Chemotherapy

Conditions

Depression, Fatigue, Leukemia, Musculoskeletal Complications, Psychosocial Effects of Cancer and Its Treatment

Being tested

Resting vitals, Body Composition, Timed Get-up and Go test (TGUG)., Cardiorespiratory assessment, Handgrip evaluation

Keywords

fatigue, depression, psychosocial effects of cancer and its treatment, musculoskeletal complications, acute undifferentiated leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia, recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia

Medical subject headings

Depression, Fatigue, Leukemia, Leukemia, Biphenotypic, Acute, Congenital Abnormalities, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Resting vitalsBehavioural

  The fitness assessments will include the assessment of resting vitals including, blood pressure, heart rate, and hemoglobin saturation (pulse oximeter).

• Body CompositionBehavioural

  Body composition and body circumference measurements (anthropometry) will be the only assessments performed multiple times during the study to monitor possible changes in the body composition and swelling of the patients. Body composition analyses will be performed via skinfold measurements following generalized three-site skinfold equations for male and females as recommended by the ACSM, 2005 and via the utilization of a bioelectrical impedance body fat analyzer device.

• Timed Get-up and Go test (TGUG).Behavioural

  The functional mobility of the subjects that will participate in the study will be assessed through the Timed Get-up and Go test (TGUG). The administration of the TGUG includes measuring a distance of 3 meters from the legs of a straight-backed armchair with a seat height of approximately 46 centimeters. The subject will be asked to sit with the back against the chair with the arms on the arm rests. When instructed to begin the test (on the command "Go"), the subject will have to stand upright then walk at a normal walking pace toward the 3 meters mark placed on the ground, turn around, return to the chair, and sit down. The stopwatch was started on the word "Go" and stopped when the subject gets back to starting position.

• Cardiorespiratory assessmentBehavioural

  The cardiorespiratory assessment will be performed on a recumbent cycle ergometer. Subjects will be asked to cycle at a target submaximal intensity of 60 % of their percentage of heart rate range until a RPE (Rate of Perceived Exertion) of 7 is reached on the modified Borg Scale or when the subject requests termination. The Borg modified RPE scale is a scale ranging from 0 to 11 where 0 means no exertion at all and 11 equals to an exertion of absolute maximum. The total time cycling and heart rate (HR) at the end of the test will be recorded immediately after the test is completed.

• Handgrip evaluationBehavioural

  Handgrip strength will be tested using a handgrip dynamometer. Subjects will be asked to stand and hold the handgrip dynamometer in one hand lined with the forearm that will be placed beside the body. Maximum grip strength is then determined without swinging the arm and by squeezing the handgrip dynamometer as hard as possible using one brief maximal contraction with no extraneous body movement. The test will be administered three times for each hand with a one-minute rest in between trials. The best score within the three trials for each arm will be the one that will be used for analysis.

• Dynamic muscular enduranceBehavioural

  Subjects will be asked to squat to a 75 degree knee angle with moderate speed, pressing back against the ball at all times. This is repeated as many repetitions as it takes for the subject to report an RPE of 7 or wishes to stop. The second test is the biceps curl exercise. The biceps curls exercise test will follow a protocol developed at the Rocky Mountain Cancer Rehabilitation Institute (RMCRI), Greeley, Colorado. The protocol involves the administration of the exercise biceps curls, done with dumbbells. Subjects will be asked to perform as many repetitions as possible during an alternated biceps curl exercise using a percentage of their body weight as resistance.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Effects of an individualized prescriptive exercise intervention

   All patients will participate in an individualized prescriptive exercise intervention 3 to 4 times per week (depending on the physical status of each patient during each week) for a period of 6 weeks. The exercise intervention will begin on week 1 of the study, the day after the first battery of initial assessments is concluded. Each exercise session will be divided into two bouts. One bout will be administered in the morning and the second one late in the afternoon

   Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted11 Jul 2007 (estimated)
2. Study startFeb 2006
3. Primary completionJan 2007
4. Study completionAug 2009

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for DepressionStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.