Exercise Program for Pediatric Cancer Mobility

Recruiting at 2 trial locations

Overseen By Priti Tewari

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Respiratory issues, Hypoxia, Hypotension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 21 days post-HSCT

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an exercise program called TEAM Me can improve fitness and quality of life for children and young adults with cancer undergoing a blood stem cell transplant. The program encourages movement by rewarding participants with tokens (stickers) for activities like walking, which they can trade for prizes. The goal is to determine if this approach can boost physical activity and well-being in these patients. Children and young adults admitted to a pediatric ward for a stem cell transplant who can participate in physical activities may be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the TEAM Me Exercise Program is safe for pediatric cancer patients?

Studies have shown that the TEAM Me exercise program is safe for young cancer patients. The program uses fun rewards, like stickers, to motivate kids and teens to stay active. Research indicates that this program significantly increased patient participation in exercise and physical therapy. Notably, the percentage of patients refusing physical therapy decreased from 24% to just 2%. With no reports of negative effects, the program is well-tolerated. This suggests that the TEAM Me program is a safe way to help young patients remain active during treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TEAM Me Exercise Program because it offers a personalized approach to improving mobility in pediatric cancer patients, which is not typically a focus of standard cancer treatments like chemotherapy or radiation. This program uniquely combines physical activity with motivational incentives, using a sticker system to encourage participation. By tailoring activities to each patient's abilities, it aims to enhance quality of life and reduce fatigue in a way that traditional treatments do not address. This innovative approach has the potential to significantly improve recovery and overall well-being during and after cancer treatment.

What evidence suggests that the TEAM Me Exercise Program is effective for improving mobility in pediatric cancer patients?

Studies have shown that the TEAM Me exercise program, which participants in this trial will follow, greatly increases activity levels in young cancer patients. Research indicates that more children are participating in physical therapy, with refusals dropping from 24% to just 2%. This program also improves overall fitness and quality of life. By using rewards like stickers to motivate children, the program encourages more walking and active time. These findings suggest that TEAM Me effectively boosts physical activity and well-being in young patients undergoing stem cell transplants. ^{1 2 3 4 5}

Who Is on the Research Team?

Priti Tewari

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for pediatric and young adult cancer patients aged 6 to less than 30 years, undergoing blood stem cell transplant. They must be able to consent and follow study procedures. It's not for those with conditions that limit physical activity or those admitted to adult units at MD Anderson.

Inclusion Criteria

I, or my guardian, agree to sign up for the Fitbit study PA18-0130.

Participants or guardians are willing and able to give written informed consent either prior to admission or within 48 hours following admission and to comply with all of the study activities and procedures

I am admitted to a hospital for a stem cell transplant to treat cancer.

Exclusion Criteria

I cannot do any physical activity due to severe health issues like breathing problems or active bleeding.

At MD Anderson HSCT patients admitted to adult units for their transplant will not be eligible as TEAM Me is an established program on the G9 Pediatrics Unit only

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the TEAM Me exercise program, including a 6-minute walk test and a timed get up and go test, with activities tailored by physical/occupational therapists.

Up to 21 days post-HSCT

Multiple visits during hospital stay

Follow-up

Participants are monitored for changes in physical fitness, quality of life, and other health metrics up to 100 days post-HSCT.

Up to 100 days post-HSCT

What Are the Treatments Tested in This Trial?

Interventions

• TEAM Me Exercise Program

Trial Overview The TEAM Me exercise program is being tested, which uses rewards like stickers to encourage walking and other activities in young cancer patients during a stem cell transplant. The impact on fitness, activity levels, quality of life, and function will be measured.

How Is the Trial Designed?

Group I: Supportive Care (TEAM Me) Experimental Treatment 4 Interventions

Patients complete a 6-minute walk test and a timed get up and go test on the day of hospital admission, on days 0 (day of stem cell transplant) and 21, the day of discharge, and day 100. Patients also complete surveys over 10 minutes about quality of life and fatigue levels on the day of hospital admission, on days 0 (day of stem cell transplant) and 21, the day of discharge, and day 100. Patients who are able and allowed to, may also walk and participate in other intense physical activities to earn stickers. Patients who are unable to walk have tailored goals created by a physical/occupational therapist to earn stickers and participate in physical activity as prescribed by their therapist.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Exercise interventions for pediatric cancer patients during inpatient treatment show good adherence and positive trends in health status, based on a review of 10 studies involving 204 patients.

No adverse events were reported, suggesting that physical activity programming can be safely integrated into the care of pediatric oncology inpatients to help mitigate the negative effects of inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. Rustler, V., Hagerty, M., Daeggelmann, J., et al.[2022]

An 11-week precision-based exercise program significantly improved exercise tolerance in 226 children and adolescents with hematological malignancies, with notable gains in strength, flexibility, and certain balance measures.

The program's effectiveness was particularly pronounced in patients who participated at high frequencies, suggesting that regular exercise can enhance recovery and social inclusion prospects for these young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision-based exercise as a new therapeutic option for children and adolescents with haematological malignancies. Lanfranconi, F., Zardo, W., Moriggi, T., et al.[2021]

Physical activity (PA) is safe and beneficial for children and adolescents with cancer, as confirmed by a scoping review of 20 review articles and 69 experimental studies, which showed improvements in various outcomes related to physical, psychosocial, and cognitive health.

Despite some reported adverse events like treatable injuries and fatigue, the overall evidence supports the positive impact of PA, highlighting the need for more rigorous research to better understand its effects and optimize interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesizing the literature on physical activity among children and adolescents affected by cancer: evidence for the international Pediatric Oncology Exercise Guidelines (iPOEG). Wurz, A., McLaughlin, E., Lategan, C., et al.[2021]

An inhospital exercise program combining aerobic and muscle strength training significantly increased muscle strength in pediatric cancer patients undergoing chemotherapy, with participants showing improvements of 40% in leg press and 24% in bench press after 19 weeks of training.

The program was safe, with no major adverse events reported, and participants maintained an adherence rate of 68%, indicating that exercise can be effectively integrated into the treatment regimen for young cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Intervention in Pediatric Patients with Solid Tumors: The Physical Activity in Pediatric Cancer Trial. Fiuza-Luces, C., Padilla, JR., Soares-Miranda, L., et al.[2022]

A 6-week walking exercise program for children and adolescents with cancer led to significant improvements in exercise tolerance and reductions in cognitive and general fatigue, with 72-89% adherence among participants.

While the walking exercise was effective in enhancing physical endurance and reducing fatigue, it did not significantly improve sleep quality or overall quality of life, suggesting a targeted benefit primarily in physical activity and fatigue management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the effects of walking as an exercise intervention for children and adolescents with cancer: A feasibility study. Su, HL., Wu, LM., Chiou, SS., et al.[2019]

Children and adolescents with cancer often experience high levels of physical inactivity during and after treatment, which negatively impacts their physical performance and quality of life.

Implementing targeted physical exercise therapy sessions in hospitals can effectively promote physical activity, enhancing functional mobility and overall health for childhood cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical Activity Promotion and Exercise in Pediatric Oncology - Structural Requirements and Financing Options Based on the Leipzig Movement Concept]. Söntgerath, R., Küpper, L., Wulftange, M., et al.[2019]

Exercise programs during hospitalization for children and adolescents with cancer can significantly improve muscle strength, physical fitness, and overall functionality, based on a systematic review of 9 studies involving 172 participants aged 4 to 18 years.

No adverse events were reported during the exercise interventions, indicating that these programs are safe for young patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EFFECTS OF PHYSICAL EXERCISE DURING HOSPITALIZATION IN CHILDREN AND ADOLESCENTS WITH CANCER: A SYSTEMATIC REVIEW. Santos, SDS., Moussalle, LD., Heinzmann-Filho, JP.[2021]

Physical activity (PA) is safe and beneficial for children and adolescents with cancer, but there are still significant gaps in knowledge and practice regarding its implementation.

The article outlines research and innovation needs identified by international experts, which aim to enhance understanding and practices in pediatric exercise oncology, ultimately helping more young cancer patients benefit from increased physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing the Field of Pediatric Exercise Oncology: Research and Innovation Needs. Wurz, A., McLaughlin, E., Chamorro Viña, C., et al.[2021]

A study involving 41 pediatric patients with leukemia or non-Hodgkin lymphoma showed that both strength exercise interventions and standard care improved the ability to accomplish daily activities during treatment, indicating that exercise is beneficial for maintaining autonomy.

While both groups maintained their ability to perform daily activities, the group that received targeted strength training showed trends towards better muscular explosive and endurance strength, suggesting that specific strength exercises may offer additional benefits during intensive cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of strength exercise interventions on activities of daily living, motor performance, and physical activity in children and adolescents with leukemia or non-Hodgkin lymphoma: Results from the randomized controlled ActiveADL Study. Gaser, D., Peters, C., Oberhoffer-Fritz, R., et al.[2022]

Young cancer patients and survivors experience significant health issues affecting their cardiovascular, musculoskeletal, metabolic, and psychosocial well-being, and they are less physically active than their healthy peers.

Integrating exercise programs into cancer care for children is rare, but pediatric oncologists can play a crucial role in promoting the benefits of physical activity, which may improve health outcomes and reduce mortality risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sport activities and exercise as part of routine cancer care in children and adolescents. Spreafico, F., Murelli, M., Timmons, BW., et al.[2020]

Exercise interventions for pediatric cancer patients and survivors significantly improve various health outcomes, including fatigue, muscle strength, aerobic capacity, and psychosocial health, based on a comprehensive review of literature up to January 2023.

The review included participants under 19 years of age and found that exercise had limited and not serious adverse effects, highlighting its safety as a complementary intervention in managing the side effects of cancer and its treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise and Physical Activity Levels on Childhood Cancer: An Umbrella Review. Rapti, C., Dinas, PC., Chryssanthopoulos, C., et al.[2023]

Physical activity is safe and feasible for pediatric oncology patients, particularly those with acute lymphoblastic leukemia (ALL), and has shown positive effects on fatigue, strength, and quality of life without any reported adverse effects.

While the evidence suggests benefits of exercise on various health aspects, including the immune system and physical functioning, more high-quality research is needed to develop specific exercise recommendations tailored to the unique needs of children with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise interventions in pediatric oncology: a systematic review. Baumann, FT., Bloch, W., Beulertz, J.[2022]

Regular physical exercise is safe and potentially beneficial for childhood cancer survivors, helping to reduce long-term adverse effects associated with cancer treatment.

The systematic review highlights that exercise can be an effective complementary therapy during and after cancer treatment, including during aggressive phases like hematopoietic stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and Childhood Cancer-A Historical Review. Morales, JS., Valenzuela, PL., Velázquez-Díaz, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8870635/

Totally Excited about Moving Mobility and Exercise (TEAM ... An incentive-based exercise program for young oncology inpatients greatly improved patient activity levels, participation in physical therapy and influenced ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35204907/

Totally Excited about Moving Mobility and Exercise (TEAM ... Conclusions: An incentive-based exercise program for young oncology inpatients greatly improved patient activity levels, participation in physical therapy and ...

3. mdpi.com mdpi.com/2227-9067/9/2/186

Totally Excited about Moving Mobility and Exercise (TEAM ... An incentive-based exercise program for young oncology inpatients greatly improved patient activity levels, participation in physical therapy and influenced ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-11750

Exercise Program (TEAM Me) for the Improvement of ... Participating in the exercise program may result in increased physical fitness, physical activity level, quality of life, and function in pediatric and ...

5. researchgate.net researchgate.net/publication/358310596_Totally_Excited_about_Moving_Mobility_and_Exercise_TEAM_Me_A_Successful_Multidisciplinary_Exercise_Quality_Improvement_Initiative_for_Pediatric_and_Young_Adult_Oncology_and_Stem_Cell_Transplant_Inpati

Totally Excited about Moving Mobility and Exercise (TEAM M) Results: Compared to baseline, patient refusals to participate in physical therapy decreased significantly (24% vs. 2%) (p < 0.02), and staff ...