Acute Lymphoblastic LeukemiaNCT02118324
Exergaming Intervention in ALL Patients
A study testing Exergaming Program in people with Acute Lymphoblastic Leukemia, run by University of Minnesota at 1 site in United States.
Trial summary
This is a pilot feasibility study to collect preliminary data for a large-scale exergaming intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention control group. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Exergaming Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jan 2016
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Eligibility will not be restricted by race or sex
- Pediatric patients with ALL diagnosis, treated at the University of Minnesota Amplatz Children's Hospital or Children's Hospitals and Clinics of Minnesota
- At least 3 months into the maintenance phase, with at least 6 months left of maintenance therapy
- Age 5-17 years at time of study enrollment
- Not smoking
- Currently not involved in a regular (3 times per week) exercise program
Who cannot join
- Individuals with a physical or mental impairment which would preclude their ability to perform the intervention.
- Bone marrow transplant recipients.
- Any woman currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing
- Due to the intervention being in English, non-English speakers will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Amplatz Children's Hospital
Minneapolis, Minnesota, 55454
About this study
Official title: The Effect of a Home-based Fitness Intervention on Cardiometabolic Risk Profile in Acute Lymphoblastic Leukemia (ALL) Patients
This is a pilot feasibility study to collect preliminary data for a large-scale exergaming intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention control group. The intervention will consist of 30 minute sessions of exergaming 3-5 times a week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology graduate students for safety and compliance. Physical activity at baseline and at the end of study will be assessed using accelerometers. Outcome measures will include: anthropometrics, blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting glucose, LDL-cholesterol, HDL- cholesterol, triglycerides, functional mobility and endurance, and strength.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Exergaming Program
- Keywords
- Acute Lymphoblastic Leukemia, ALL, fitness intervention
- 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.
Exergaming ProgramBehavioural
Participants will exercise through exergaming play.
| Study group | Role | What they receive |
|---|---|---|
| Exercise treatment | Experimental | Participants will be instructed to use the exergaming program at home for 30 mins, 3-5 times per week. Receives: Behavioral: Exergaming Program |
| Control group | No intervention | No intervention is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average minutes of physical activity per day
The feasibility of an exercise intervention in pediatric ALL patients undergoing maintenance therapy and its effects on markers of cardiometabolic risk. The primary outcome for this pilot study is average minutes and time spent at varying intensity of physical activity per day, as measured by accelerometers.
Measured: 6-months
Secondary outcomes (4)
Average difference of blood pressure
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of blood pressure.
Measured: 6 months
Average difference of body composition
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of body composition.
Measured: 6 months
Average difference in visceral fat
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of visceral fat.
Measured: 6 months
Average difference in triglycerides
Estimate of the likely effect size (i.e., difference between the groups in average outcome) of triglycerides.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionJan 2016
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Steinberger, MD, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118324
- Sponsor's protocol ID
- 2013NTLS119
- Status last verified
- Mar 2017
- First submitted
- 26 Mar 2014
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Home-based Fitness Intervention on Cardiometabolic Risk Profile in Acute Lymphoblastic Leukemia (ALL) Patients
- ClinicalTrials.gov ID
- NCT02118324
- Acronym / sponsor ID
- 2013NTLS119
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, ALL, fitness intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Apr 2014 (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.
This is a pilot feasibility study to collect preliminary data for a large-scale exergaming intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention control group. The intervention will consist of 30 minute sessions of exergaming 3-5 times a week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology graduate students for safety and compliance. Physical activity at baseline and at the end of study will be assessed using accelerometers. Outcome measures will include: anthropometrics, blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting glucose, LDL-cholesterol, HDL- cholesterol, triglycerides, functional mobility and endurance, and strength.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise treatment | Experimental | Behavioral: Exergaming ProgramParticipants will be instructed to use the exergaming program at home for 30 mins, 3-5 times per week. |
| Control group | No intervention | –No intervention is provided. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Eligibility will not be restricted by race or sex
- Pediatric patients with ALL diagnosis, treated at the University of Minnesota Amplatz Children's Hospital or Children's Hospitals and Clinics of Minnesota
- At least 3 months into the maintenance phase, with at least 6 months left of maintenance therapy
- Age 5-17 years at time of study enrollment
- Not smoking
Key exclusion criteria (4 listed)
- Individuals with a physical or mental impairment which would preclude their ability to perform the intervention.
- Bone marrow transplant recipients.
- Any woman currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing
- Due to the intervention being in English, non-English speakers will be excluded
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 |
|---|---|---|
| Exergaming ProgramParticipants will exercise through exergaming play. | Behavioural | Exercise treatment |
Primary outcome
Average minutes of physical activity per day
Time frame: 6-months
The feasibility of an exercise intervention in pediatric ALL patients undergoing maintenance therapy and its effects on markers of cardiometabolic risk. The primary outcome for this pilot study is average minutes and time spent at varying intensity of physical activity per day, as measured by accelerometers.
4 secondary outcomes
Average difference of blood pressure
Time frame: 6 months
Average difference of body composition
Time frame: 6 months
Average difference in visceral fat
Time frame: 6 months
Average difference in triglycerides
Time frame: 6 months
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 14 Mar 2017.
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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.
Julia Steinberger, MD, MS principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming Program in people with Acute Lymphoblastic Leukemia, run by University of Minnesota at 1 site 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Average minutes of physical activity per day (time frame: 6-months). 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 14 Mar 2017.