Development, feasibility, and efficacy of a co-designed exercise program for survivors of paediatric sarcoma

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000454572

Enrollment

Registered

2024-04-12

Start date

2025-11-05

Completion date

2026-06-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is determining if a novel co-designed therapeutic exercise program is feasible, acceptable, and potentially effective for survivors of paediatric sarcoma. Who is it for? You may be eligible for this study if you are aged between 8 - 18 years of age, diagnosed with sarcoma that required surgical resection at least 12 months earlier, but no more than 5 years prior to enrolment, not undergoing any cancer treatment, and medically able to complete the exercise program. Study details Participants will receive weekly face-to-face individualised goal-directed exercise program for 12 weeks, delivered by a physiotherapist or exercise physiologist. There will also be an accompanying home-based program three times per week. Treatment completion will be checked. Assessments of participant fitness, everyday functioning and activity levels will be at the beginning and end of the program (12-weeks), and at 6 months follow up. Test will include VO2 peak, six minute walk test, timed up and go, timed up and down stairs and pTESS] If the exercise program is shown to be feasible, acceptable, and efficacious, the program has strong potential for testing in larger studies involving more research centres and subsequent use in routine clinical practice. The study will be the first to explore the feasibility, acceptability and efficacy of therapeutic exercise to improve fitness, physical function and physical activity in survivors of childhood sarcoma; improvements in these outcomes could dramatically improve the quality of survivorship and play a major role in mitigating the significant risk of disabling secondary health conditions later in life

Interventions

Brief name: Goal-directed therapeutic exercise program. Participants will receive one weekly 30-60 minute individualised, goal-directed therapeutic exercise therapy program for 12 weeks, delivered face-to-face by a trained physiotherapist or exercise physiologist, with an accompanying home-based program to be completed three times per week. Exercise intensity will be monitored using wearable sensors (ActiGraph GT3x+ and heart rate monitors) and/or perceived effort using the OMNI scale. Participants will be assessed (via questionnaire and physical assessments) at the beginning, end-intervention (~12 weeks), and at a 6-month follow-up by a trained physiotherapist or exercise physiologist. The exercise intervention will be tailored according to participant age, e.g., game-based activities for younger children, and may informally include peers or siblings to promote adherence to the home-based component. Peers or siblings will not be trained to assist with the exercise program. The exercise intervention prescribed via goal-directed therapy, aligns with the principles of the International Classification and Functioning, Disability and Health framework (ICF), and will predominately be guided by the goals set by the participant. The program will adhere to established exercise prescription guidelines, comprising of physical activity and goal-directed task specific practice. At least half of the session will be dedicated to cardiorespiratory-focused and functional strength promoting activities i.e., running, ball games and locomotion play games, body weight exercises, bear crawls, and frog jumps. The remaining half is dedicated to goal-directed activities. Goals selected will be physical activity related and may include community recreation, occupational, sport or leisure goals. Specific examples of goal-directed activities will, therefore, vary and be individualised according to each participant’s age, goals, interests and functional capacity, presence of treatment-related side effects, and co-morbidities. The home-based program will replicate the essential elements of the supervised sessions in relation to activity type and will also reflect the resources at home. Adherence to the intervention will be assessed by the physiotherapist or exercise physiologist who will complete a study logbook to record details about the exercises prescribed and the exercises completed. The CI's will evaluate adherence to the program using attendance records and data from wearable sensors. Acceptability will be measured by questionnaire and structured interviews.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

8 Years to 18 Years

Healthy volunteers

Inclusion criteria

Eligibility criteria: (1) Children (8 to 18 years); (2) diagnosis of sarcoma that required surgical resection at least 12 months earlier, but no more than 5 years (60 months) prior to enrolment; (3) no chemotherapy or radiation therapy received in the last 6 months; (4) no evidence of progressive disease; and (5) medically able to complete an exercise program.

Exclusion criteria

Exclusion criteria: (1) they have insufficient English to complete study assessments or participate in the exercise intervention; (2) the study is not suitable as assessed by the clinical lead investigator; (3) concurrent medical condition that would prohibit exercise testing or may jeopardise the ability of the patient to undergo the exercise intervention with reasonable safety. This includes but is not limited to unstable angina or arrhythmia, acute myocarditis, uncontrolled heart failure, lower extremity thrombus, uncontrolled asthma, severe mental impairment, or other inability to consent. These will be assessed on a case-by-case basis by the clinical lead investigator; (4) the participant is unable to travel to the research facility to complete study assessments.

Outcome results