Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608446
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LINFO
Brief Summary:
The most common complaints after breast surgery are postoperative pain reported in up to 68 of patients musculoskeletal problems in the shoulder and functional limitations in up to 59 of patients after mastectomy and quadrantectomy reduction in range of motion ROM in 24-53 and strength deficit
The study aims to verify the effectiveness of a telerehabilitation treatment in terms of prevention of possible complications following breast cancer surgery
Primary objective to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures
Secondary objective to study any preoperative prognostic factors for the onset of complications to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms improvement of joint ROM muscle strength and perceived quality of life
The study aims to verify the effectiveness of a telerehabilitation treatment in terms of prevention of possible complications following breast cancer surgery
Primary objective to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures
Secondary objective to study any preoperative prognostic factors for the onset of complications to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms improvement of joint ROM muscle strength and perceived quality of life
Detailed Description:
Breast cancer is the most common malignancy in women worldwide Advances in early detection and improved treatment of breast cancer have led to increased survival after diagnosis resulting in many more women living with the consequences of cancer treatment
Breast cancer surgeries and treatments can cause arm morbidity that can progress beyond 25 years
The most common complaints after breast surgery are postoperative pain reported in up to 68 of patients musculoskeletal problems in the shoulder and functional limitations in up to 59 of patients after mastectomy and quadrantectomy reduction in range of motion ROM in 24-53 and strength deficit
Other complications include postoperative axillary web syndrome AWS which can cause pain and movement limitations lymphedema reported with a prevalence of 6-52 especially after axillary lymph node dissection ALND kinematic alterations that may promote future development of rotator cuff disease scapulohumeral dyskinesia proprioception deficit postural alterations and reduced quality of life
There is scientific evidence in the literature to suggest that early postoperative exercise is safe and can improve shoulder function however uncertainty remains about the optimal content timing and cost-effectiveness of exercise interventions
The study aims to verify the effectiveness of a rehabilitation treatment in terms of prevention of possible complications following breast cancer surgery
Primary objective to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures
Secondary objective to study any preoperative prognostic factors for the onset of complications to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms improvement of joint ROM muscle strength and perceived quality of life
Breast cancer surgeries and treatments can cause arm morbidity that can progress beyond 25 years
The most common complaints after breast surgery are postoperative pain reported in up to 68 of patients musculoskeletal problems in the shoulder and functional limitations in up to 59 of patients after mastectomy and quadrantectomy reduction in range of motion ROM in 24-53 and strength deficit
Other complications include postoperative axillary web syndrome AWS which can cause pain and movement limitations lymphedema reported with a prevalence of 6-52 especially after axillary lymph node dissection ALND kinematic alterations that may promote future development of rotator cuff disease scapulohumeral dyskinesia proprioception deficit postural alterations and reduced quality of life
There is scientific evidence in the literature to suggest that early postoperative exercise is safe and can improve shoulder function however uncertainty remains about the optimal content timing and cost-effectiveness of exercise interventions
The study aims to verify the effectiveness of a rehabilitation treatment in terms of prevention of possible complications following breast cancer surgery
Primary objective to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures
Secondary objective to study any preoperative prognostic factors for the onset of complications to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms improvement of joint ROM muscle strength and perceived quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None