Clinical trial NCT05779670: Adherence to a Personalized Home Exercise Program in Patients With Bone Tumor Undergoing Lower Extremity Salvage Surgery
Official title: Treatment Adherence to a Personalized Home Exercise Program in Patients With Bone Cancer Undergoing Lower Extremity Resection and Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteosarcoma
Ewing Sarcoma
Chondrosarcoma
Bone Tumor
Keywords: rehabilitation
home based exercise
bone tumor
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Will be recruited consecutively all patients with bone cancer undergoing resection and reconstruction of the lower limb at the "Orthopedic and Traumatological Clinic III to prevalent oncological address" of the Rizzoli Orthopaedic Institute in the period from 01/2023 to 12/2024 and subsequently to the "SC Osteoncologia, sarcomas of bone and soft tissues, and innovative therapies of the same hospital for the continuation of treatment" in the next six months after surgery.

Brief summary: The objective of this study is to describe adherence to a personalised home exercise program in patients undergoing resection and reconstruction of lower limb for bone tumor and neoadjuvant chemotherapy treatment in the first six months after surgery intervention and investigate possible prognostic factors.

Detailed description: In cancer patients undergoing adjuvant therapies, rehabilitation plays an important role in reducing the side effects of chemotherapy treatment by promoting cardiorespiratory function, reducing fatigue and improving quality of life. Physiotherapy treatment, generally, includes physical training programs administered in many ways, not yet well standardized. With the aim of seeking an empowerment of the patient and his active participation, more and more exercise programs are used that the patient is able to manage independently. Adherence to and compliance with such exercise programs is extremely variable in literature and can range from 52% to 89%. A high level of adhesion is a well-known challenge and a fundamental prerequisite for achieving the benefits of physical activity. Home exercise programs to be performed in complete autonomy have been proposed in patients with different types of cancer, while for patients with bone tumor, to date there are no experiences. In this group of patients the role of physiotherapy is significant not only to counteract the adverse effects of chemotherapy treatment but also to promote the recovery of patients following the important resection and reconstruction interventions. In this type of patient, a high adherence to the physiotherapy treatment started already during the periods of hospitalization for the administration of antiblastic treatment.

Data will be collected from all patients treated consecutively over two years according to the defined inclusion criteria. Given the rarity of oncologic pathology of the musculoskeletal system and the limited number of patients of 27 found to meet the inclusion criteria in the year 2021, it is assumed that data will be collected from a sample of 50 patients.

The variables collected will be: age, sex, BMI, smoking, physical activity level, diagnosis, metastasis at diagnosis, type of surgery, chemotherapy treatment.

Data will be described by mean and standard deviation or median and interquartile range values according to the nature of the data and frequency and percentage for dichotomous variables

The objective of this study is to describe adherence to a personalised home exercise program in patients undergoing resection and reconstruction of lower limb for bone tumor and neoadjuvant chemotherapy treatment in the first six months after surgery intervention and investigate possible prognostic factors.

Eligibility criteria: Inclusion Criteria:

* patients aged 12 years with bone tumor undergoing surgery (resection and reconstruction of the lower limb) and in adjuvant treatment
* patients under physiotherapy treatment

Exclusion Criteria:

* patients with difficulties in understanding the Italian language
* patients not using digital services

Primary outcomes:
measure: adherence to the rehabilitation program
timeFrame: everyday from baseline at 6 months
Secondary outcomes:
measure: TESS
timeFrame: at 3 months and at 6 months
measure: TUG
timeFrame: at 3 months and at 6 months
measure: patient satisfaction
timeFrame: at 3 months and at 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: ufficio ricerca professioni sanitarie
name: alida abbruzzese
role: PRINCIPAL_INVESTIGATOR
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