Acute Lymphoblastic LeukemiaXRCISLNCT00766311
Aerobic and Strengthening Exercise for Acute Leukemia
A study testing Gross Motor Function, Knee extension strength and Hand grip strength in people with Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Gross Motor Function, Knee extension strength and Hand grip strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with childhood ALL when age greater than 1 and less than 10 at diagnosis, white blood cell count less than 50,000 cells/microliter and receiving continuation/maintenance therapy based on the original disease classification
- In first remission
- Maintenance phase of therapy (Eligibility extends from Day 0 of maintenance therapy up to six months prior to the completion of therapy)
- Current age 5-10 years
- Modified Lansky performance scale must score 60 or higher at time of enrollment
- Written informed consent
Who cannot join
- Lower extremity amputation or congenital deformity of lower limb
- History of pre-existing neuron-motor or neuro-developmental disorder prior to diagnosis of childhood ALL, such as mental retardation, Down syndrome, cerebral palsy, and traumatic brain injury
- Pre-existing heart or lung disease by clinical history
- Children with specific contraindications to exercise will be offered enrollment after this transient condition is resolved: severe anemia (Hemoglobin less than 8 g/dl), fever greater than 38 degrees Centigrade, platelets less than 50*109/ul, neutrophil counts less than 0.5*109/ul.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37215
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Gross Motor Function, Knee extension strength, Hand grip strength, Flexibility, Ankle range of motion
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross Motor FunctionOther
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.
Knee extension strengthOther
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 strengthOther
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.
FlexibilityOther
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 range of motionOther
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
Aerobic capacityOther
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
Body composition and vital signsOther
Height, body mass index, waist circumference, and blood pressure will be measured.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | This single-arm feasibility trial will evaluate the administration of an aggressive exercise regimen. Receives: Other: Gross Motor Function; Other: Knee extension strength; Other: Hand grip strength; Other: Flexibility; Other: Ankle range of motion; Other: Aerobic capacity; Other: Body composition and vital signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 institutional staff.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Ness, PT, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766311
- Sponsor's protocol ID
- XRCISL
- Acronym
- XRCISL
- Status last verified
- Jan 2012
- First submitted
- 1 Oct 2008
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic and Strengthening Exercise for Acute Leukemia
- ClinicalTrials.gov ID
- NCT00766311
- Acronym / sponsor ID
- XRCISL / XRCISL
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Gross Motor Function, Other: Knee extension strength, Other: Hand grip strength, Other: Flexibility, Other: Ankle range of motion, Other: Aerobic capacity, Other: Body composition and vital signsThis single-arm feasibility trial will evaluate the administration of an aggressive exercise regimen. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosed with childhood ALL when age greater than 1 and less than 10 at diagnosis, white blood cell count less than 50,000 cells/microliter and receiving continuation/maintenance therapy based on the original disease classification
- In first remission
- Maintenance phase of therapy (Eligibility extends from Day 0 of maintenance therapy up to six months prior to the completion of therapy)
- Current age 5-10 years
- Modified Lansky performance scale must score 60 or higher at time of enrollment
Key exclusion criteria (4 listed)
- Lower extremity amputation or congenital deformity of lower limb
- History of pre-existing neuron-motor or neuro-developmental disorder prior to diagnosis of childhood ALL, such as mental retardation, Down syndrome, cerebral palsy, and traumatic brain injury
- Pre-existing heart or lung disease by clinical history
- Children with specific contraindications to exercise will be offered enrollment after this transient condition is resolved: severe anemia (Hemoglobin less than 8 g/dl), fever greater than 38 degrees Centigrade, platelets less than 50*109/ul, neutrophil counts less than 0.5*109/ul.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gross Motor FunctionThe 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. | Other | 1 |
| Knee extension strengthMaximum 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." | Other | 1 |
| Hand grip strengthHand 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. | Other | 1 |
| FlexibilityFlexibility 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. | Other | 1 |
| Ankle range of motionAnkle 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 | Other | 1 |
| Aerobic capacityParticipants 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 | Other | 1 |
| Body composition and vital signsHeight, body mass index, waist circumference, and blood pressure will be measured. | Other | 1 |
Primary outcome
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 institutional staff.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Ness, PT, PhD principal investigator
St. Jude Children's Research Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gross Motor Function, Knee extension strength and Hand grip strength in people with Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 institutional staff. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2012.