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

Trial Summary

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 data supports the effectiveness of the treatment Physical Activity for Lymphoblastic Leukemia?

Research shows that exercise can improve physical performance and body composition in patients with acute lymphoblastic leukemia (ALL), similar to healthy individuals. Encouraging physical activity in ALL survivors is important as it correlates with better muscle performance and helps avoid obesity. ^{1 2 3 4 5}

Is physical activity safe for people with acute lymphoblastic leukemia?

Research suggests that exercise is generally safe for children with acute lymphoblastic leukemia (ALL) during and after treatment, although they may experience lower levels of physical activity compared to healthy children. Exercise programs can help prevent some side effects of ALL treatment, like reduced bone density and impaired motor skills. ^{2 4 5 6 7}

How does the physical activity treatment for lymphoblastic leukemia differ from other treatments?

This treatment is unique because it focuses on incorporating physical activity, such as exercise routines, to improve physical performance and body composition in patients with acute lymphoblastic leukemia (ALL). Unlike traditional treatments that primarily involve chemotherapy, this approach aims to counteract the negative effects of cancer therapy on physical fitness and quality of life. ^{1 2 3 4 5}

Research Team

Andrea Orsey

Principal Investigator

Connecticut Children's Medical Center

Eligibility Criteria

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 either younger than 8 or older than 18 years old.

I am an English speaker.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physical performance of nontransplanted childhood ALL survivors is comparable to healthy controls. [2013]

2. Netherlands 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. [2021]

3. Switzerland 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Physical activity during treatment in children with leukemia: a pilot study. [2017]

6. United States 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. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Physical activity and fitness in adolescent and young adult long-term survivors of childhood acute lymphoblastic leukaemia. [2021]