Tailored Exercise Program for Childhood Cancer Survivors with Limited Mobility

Overseen By Kirsten K. Ness

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Pregnancy, Psychological distress, Heart failure, others

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

Compensation: Varies

Number of Visits: 9

Duration: 20 weeks

181 Participants Needed

Trial Summary

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's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Individually tailored exercise program for childhood cancer survivors with limited mobility?

Research shows that exercise training can improve physical function and fitness in childhood cancer survivors, such as those with brain tumors or leukemia, suggesting that a tailored exercise program could help improve mobility and overall health in these individuals. ^{1 2 3 4 5}

Is a tailored exercise program safe for childhood cancer survivors?

Research on exercise programs for childhood cancer survivors shows that they can help improve physical fitness and quality of life without significant safety concerns. One study specifically monitored adverse events (safety issues) and found no major problems, suggesting that these programs are generally safe for participants. ^{1 6 7 8 9}

How is the tailored exercise program treatment different from other treatments for childhood cancer survivors with limited mobility?

The tailored exercise program is unique because it is customized to each child's specific needs and abilities, focusing on improving physical function and fitness, which is not typically addressed by standard treatments. This personalized approach aims to enhance quality of life and mitigate long-term health issues that childhood cancer survivors often face. ^{1 2 3 7 10}

What is the purpose of this trial?

The participants are asked to take part in this clinical trial, a type of research study. The participants are SJLIFE study participants and may have a hard time exercising (exercise intolerance) due to side effects of cancer treatment received as a child.This study is being done to determine if a personalized exercise plan will help childhood cancer survivors who have exercise intolerance become more active. Primary Objectives: To achieve the goal of this study, we propose the following three Objectives: Primary Objective 1: To determine the efficacy of an individually tailored, home-delivered aerobic and strengthening intervention to improve exercise capacity in survivors of childhood cancer with exercise intolerance (peak oxygen uptake (peak VO2) \<85% of age and sex predicted). Primary Objective 2: To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on measures of cardiac, pulmonary, musculoskeletal, and neurosensory function in survivors of childhood cancer with exercise intolerance. Primary Objective 3: To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on emotional health, participation in family and community activities, quality of life, and cognitive function in survivors of childhood cancer with exercise intolerance.

Research Team

Kirsten K. Ness

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for childhood cancer survivors aged 18-40 with limited exercise ability due to past treatments. They must understand how to use ZOOM and a heart rate monitor, have internet access, and get clearance from a study doctor. It's not for those in other exercise programs, very active individuals, pregnant women, or those needing urgent medical care.

Inclusion Criteria

You are a participant in the SJLIFE study.

You need to have access to the internet.

Clearance for participation in exercise by a study physician

Exclusion Criteria

Research Participant Recruitment and Screening

I need urgent treatment for a serious heart condition.

I am experiencing severe emotional distress.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an individually tailored, home-delivered aerobic and strengthening intervention or generalized exercise recommendations

20 weeks

3 visits (in-person) at baseline, 4 months, and 10 months

Follow-up

Participants are monitored for sustainability of exercise capacity improvements and other health measures

6 months

Follow-up assessments at 6 months after week 20

Treatment Details

Interventions

• Individually tailored exercise program

Trial Overview The study tests if a personalized home-based aerobic and strengthening program can improve physical capacity in these survivors. It also looks at the effects on heart, lung function, muscles, nerves, emotional health, social participation, life quality and thinking skills.

Participant Groups

Group I: Personalized exercise group (INTGroup) Experimental Treatment 2 Interventions

Participants in this group have individually tailored exercise program with supervision, 20 weeks,clinic 3 times during the course of this study: at baseline (this appointment), at 4 months and 10 months from now for follow-up.

Group II: Generalized exercise group, Attention Control (AC Group) Experimental Treatment 2 Interventions

Study participants in this group receive generalized exercise recommendations, 20 weeks,clinic 3 times during the course of this study: at baseline (this appointment), at 4 months and 10 months from now for follow-up.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A controlled clinical trial involving 28 children who survived brain tumors showed that exercise training significantly improved physical functioning, particularly in bilateral coordination, with benefits lasting up to 12 weeks after training ended.

Participants in group training settings also experienced increased cardiopulmonary fitness, as indicated by improved work rates, highlighting the effectiveness of structured exercise programs for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training improves physical function and fitness in long-term paediatric brain tumour survivors treated with cranial irradiation. Piscione, PJ., Bouffet, E., Timmons, B., et al.[2018]

The study is evaluating a tailored exercise intervention for childhood cancer survivors with exercise intolerance, involving 160 participants randomized into intervention and control groups over a 20-week period.

The intervention includes a personalized exercise plan delivered via telehealth, aiming to improve physical activity levels and overall health without the need for travel, which may enhance adherence and confidence in exercising.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and methods of a randomized telehealth-based intervention to improve fitness in survivors of childhood cancer with exercise intolerance. Maharaj, A., Jefferies, JL., Mulrooney, DA., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise training improves physical function and fitness in long-term paediatric brain tumour survivors treated with cranial irradiation. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of interdisciplinary rehabilitation in child cancer survivors: Impact on physical fitness, fatigue and body composition after 1-year follow-up. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Cardiorespiratory fitness and health-related quality of life in survivors of childhood central nervous system tumours. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Short and long-term impairments of cardiopulmonary fitness level in previous childhood cancer cases: a systematic review. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Targeted Exercise on Gross Motor and Neuromuscular Performance in Survivors of Childhood Leukemia: A Pilot Study. [2022]

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

Design and methods of a randomized telehealth-based intervention to improve fitness in survivors of childhood cancer with exercise intolerance. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A partially supervised physical activity program for adult and adolescent survivors of childhood cancer (SURfit): study design of a randomized controlled trial [NCT02730767]. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Using qualitative and co-design methods to inform the development of an intervention to support and improve physical activity in childhood cancer survivors: a study protocol for BEing Active after ChildhOod caNcer (BEACON). [2021]

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

Randomized web-based physical activity intervention in adolescent survivors of childhood cancer. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Designing an exercise intervention for adult survivors of childhood cancers. [2023]