Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05779670
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-03-06
Brief Title:
Adherence to a Personalized Home Exercise Program in Patients With Bone Tumor Undergoing Lower Extremity Salvage Surgery
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Treatment Adherence to a Personalized Home Exercise Program in Patients With Bone Cancer Undergoing Lower Extremity Resection and Reconstruction
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADER
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None