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Trial Title:
Adherence to a Personalized Home Exercise Program in Patients With Bone Tumor Undergoing Lower Extremity Salvage Surgery
NCT ID:
NCT05779670
Condition:
Osteosarcoma
Ewing Sarcoma
Chondrosarcoma
Bone Tumor
Conditions: Official terms:
Osteosarcoma
Sarcoma, Ewing
Chondrosarcoma
Bone Neoplasms
Conditions: Keywords:
rehabilitation
home based exercise
bone tumor
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
12 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Ortopedico Rizzoli
Address:
City:
Bologna
Zip:
40136
Country:
Italy
Status:
Recruiting
Contact:
Last name:
alida abbruzzese
Email:
alida.abbruzzese@ior.it
Start date:
January 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Istituto Ortopedico Rizzoli
Agency class:
Other
Source:
Istituto Ortopedico Rizzoli
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05779670
