Physical Activity for Lymphoblastic Leukemia

Overseen By Andrea Orsey

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Connecticut Children's Medical Center

Must be taking: Chemotherapy

Disqualifiers: Non-ALL, Non-English, Age, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to evaluate the impact of exercise on physical activity levels and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current chemotherapy treatment, as the study involves children with leukemia who are already receiving maintenance chemotherapy.

What prior data suggests that this physical activity intervention is safe for children with acute lymphoblastic leukemia?

Research has shown that exercise is safe for children with acute lymphoblastic leukemia (ALL) undergoing chemotherapy. Studies have found that exercise does not interfere with their treatment and can be beneficial. It improves physical activity levels and motor skills. No major reports indicate that exercise causes harm or worsens chemotherapy side effects. Therefore, participating in a trial that promotes physical activity should not pose additional safety risks for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for lymphoblastic leukemia, which often involve chemotherapy and radiation, this approach focuses on physical activity as a way to support patients. Researchers are excited about this method because it empowers patients to choose from engaging activities like using a Nintendo Wii Fit or Xbox Kinect, which can help improve their physical and mental well-being. This strategy is unique because it emphasizes an active lifestyle, potentially enhancing quality of life and recovery without the side effects associated with conventional treatments.

What evidence suggests that physical activity is effective for improving quality of life in children with acute lymphoblastic leukemia?

Research has shown that exercise benefits children with acute lymphoblastic leukemia (ALL). Exercise programs improve physical fitness, movement, flexibility, and strength. Studies suggest that staying active enhances overall quality of life during and after chemotherapy. Evidence indicates that regular exercise reduces tiredness and supports recovery. In this trial, participants will engage in a physical activity program, which may help children with ALL stay healthy and feel better. ^{1 3 4 6 7}

Who Is on the Research Team?

Andrea Orsey

Principal Investigator

Connecticut Children's Medical Center

Are You a Good Fit for This Trial?

This trial is for children aged 8-18 with acute lymphoblastic leukemia (ALL) who are in the maintenance phase of chemotherapy, can speak and read English, have no exercise contraindications as per their oncologist, live with parents/guardians who consent to participation, and don't have psychiatric or neurological disorders affecting study involvement.

Inclusion Criteria

I do not have any mental or neurological conditions that would prevent me from participating.

Capable of speaking and reading English

Currently living with their parents/legal guardians

Exclusion Criteria

I am not on chemotherapy during this study.

I am not a child with leukemia in the maintenance phase.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in physical activities such as Nintendo WII fit, Xbox Kinect fit, and other sports activities during maintenance chemotherapy

1 year

Follow-up

Participants are monitored for quality of life, physical activity, sleep, and fatigue levels after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity

Trial Overview The study aims to assess how moderate physical activity affects the quality of life and activity levels in pediatric patients undergoing maintenance chemotherapy for ALL. It will measure changes due to exercise during this treatment phase.

How Is the Trial Designed?

Group I: Physical Activity Experimental Treatment 1 Intervention

Single arm study where patients choose from physical activities after baseline assessment by PT. Activities include the following: Nintendo WII fit console, Xbox Kinect fit console and other sport activities.

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

Published Research Related to This Trial

A 2-year exercise program for children with acute lymphoblastic leukemia (ALL) did not significantly prevent reductions in bone mineral density, motor performance, or ankle dorsiflexion compared to standard care, likely due to low adherence to the exercise regimen.

However, the intervention group showed a faster normalization of body fat after chemotherapy ended, suggesting some potential benefits of exercise in managing body composition post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial investigating an exercise program to prevent reduction of bone mineral density and impairment of motor performance during treatment for childhood acute lymphoblastic leukemia. Hartman, A., te Winkel, ML., van Beek, RD., et al.[2009]

A study of 21 long-term survivors of childhood acute lymphoblastic leukemia (ALL) revealed that their peak oxygen uptake (VO2 peak) was 14% lower than that of age- and sex-matched controls, indicating poorer cardiovascular fitness.

The findings highlight that a significant portion of survivors, especially females, exhibit very low levels of physical activity, emphasizing the need for promoting physical activity to improve fitness and reduce long-term health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and fitness in adolescent and young adult long-term survivors of childhood acute lymphoblastic leukaemia. Järvelä, LS., Niinikoski, H., Lähteenmäki, PM., et al.[2021]

A study involving 33 patients with acute lymphoblastic leukemia (ALL) showed that cross-training and resistance exercises significantly improved body composition and physical performance compared to a control group, which experienced muscle loss and increased fat mass.

Despite the positive effects on body composition and physical performance, the quality of life (QOL) did not show significant differences among the groups, suggesting that while exercise is beneficial for physical health, it may not directly impact overall QOL during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-Training and Resistance Training in Adults with Type B Acute Lymphoblastic Leukemia during the Induction Phase: A Randomized Blind Pilot Study. Gallardo-Rodríguez, AG., Fuchs-Tarlovsky, V., Ocharán-Hernández, ME., et al.[2023]

Children undergoing treatment for acute lymphoblastic leukemia (ALL) showed significantly lower levels of moderate-to-vigorous physical activity (MVPA) compared to age-matched healthy children, with only 328 minutes of MVPA per week versus 506 minutes in controls (p < 0.05).

None of the children with ALL met the guideline of accumulating at least 60 minutes of MVPA for 5 or more days a week, highlighting the need for encouraging physical activity in young patients to promote healthier lifestyles during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity during treatment in children with leukemia: a pilot study. Aznar, S., Webster, AL., San Juan, AF., et al.[2017]

A pilot study involving 17 children aged 5 to 10 years with acute lymphoblastic leukemia showed that a 6-month home-based exercise intervention was feasible, with 71% of participants completing the program.

The exercise intervention led to significant improvements in physical abilities, including strength and flexibility, with 67% of participants showing enhanced knee strength and 83% improving ankle flexibility, indicating potential benefits for children undergoing cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. Esbenshade, AJ., Friedman, DL., Smith, WA., et al.[2022]

Exercise and motor interventions significantly improve various physical outcomes in children with acute lymphoblastic leukemia (ALL) during and after chemotherapy, including fatigue, strength, and aerobic capacity, based on a systematic review of 19 studies involving 508 participants.

Despite the positive findings, the evidence is considered low quality, indicating a need for further research to confirm the efficacy of these interventions for enhancing motor function and physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise and motor interventions on physical activity and motor outcomes during and after medical intervention for children and adolescents with acute lymphoblastic leukemia: A systematic review. Coombs, A., Schilperoort, H., Sargent, B.[2021]

Nontransplanted acute lymphoblastic leukemia (ALL) patients showed physical performance levels comparable to healthy controls, indicating that they can maintain fitness despite their illness.

In contrast, ALL patients who underwent stem cell transplantation (SCT) exhibited poorer physical performance in most tests, highlighting the need for targeted exercise programs to improve their fitness and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical performance of nontransplanted childhood ALL survivors is comparable to healthy controls. Taskinen, MH., Kurimo, M., Kanerva, J., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8359930/

The effect of exercise and motor interventions on physical ... Similar to our review, the review found that exercise intervention resulted in positive effects on: functional mobility, flexibility, strength, BMD, aerobic ...

2. nature.com nature.com/articles/s41598-025-89703-9

Changes in physical fitness in acute leukemia patients ... Previous research has shown that exercise interventions can be safe and effective in improving patients' fitness levels with AL. Aerobic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06783738

Physical Activity in Acute Lymphoblastic Leukemia (ALL) There is increasing evidence that environmental, lifestyle factors such as physical exercise and fitness may play a beneficial role in cancer survivorship.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842820301426

The effect of exercise and motor interventions on physical ... Exercise and motor interventions result in improved physical activity and motor outcomes for children with ALL during and after chemotherapy. •. Acute: Fatigue ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12512279/

Effects of exercise interventions on physical recovery in ... Overall, a significant positive effect was observed in the 6MWT outcome, while VO₂ peak, handgrip strength, TUG, and body composition showed no ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5908317/

Physical training interventions for children and teenagers ... A decreased physical fitness has been reported in patients and survivors of acute lymphoblastic leukemia (ALL). This is influenced by the ...

7. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.982996/full

Effects of strength exercise interventions on activities ... Patients with leukemia reduce their daily step counts by 70% compared with healthy peers during inpatient stays (8). As a consequence, the ...