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The Effect of Technological Based Rehabilitation Practices After Breast Cancer Surgery

M

Medipol University

Status

Completed

Conditions

Breast Cancer

Treatments

Other: Mobile Application Supported Exercise Group
Other: Telerehabilitation Based Supervised Exercise Group
Other: Standard Physiotherapy Exercise Group

Study type

Interventional

Funder types

Other

Identifiers

NCT06156397
MEDU-FTR-BB-001

Details and patient eligibility

About

The aim is to investigate the effects of supervised exercise program, telerehabilitation program and mobile application supported exercise program, applied in the acute period after breast cancer surgery, on upper extremity dysfunction.

Full description

Breast cancer is the most common malignant tumor in women. According to the World Health Organization's 2018 data, 11.6% of new cancers worldwide are breast cancer. The overall 5-year survival rates of stage I, II, and III patients are 98%, 92%, and 75%, respectively. Therefore, the survival rate is increasing due to developments in cancer treatment.

The incidence of shoulder mobility impairment after breast cancer surgery was 2% ~ 51%. Postoperative patients' failure to exercise due to fear of pain and affected wound healing leads to poor activity of the upper extremity and shoulder joints, which often leads to limited activity and dysfunction in the affected extremities.

The use of technology in rehabilitation is rapidly increasing, and new technologies provide more motivational participation of patients in their usual care and standard programs. It has been reported that in the acute period after mastectomy, shoulder pain, fatigue, decreased joint range of motion and muscle strength, neuropathy, and consequent limitation of daily living activities.

It has been proven that passive mobilization, general exercise, manual stretching and traditional physiotherapy practices combining them are effective in treating upper extremity pain and restoring functionality after surgery.

There is no study in the literature investigating the effect of an application-based physiotherapy program on upper extremity dysfunction in patients undergoing breast cancer surgery. The aim of this study is to investigate the effects of supervised exercise program, telerehabilitation program and mobile application supported exercise program, applied in the acute period after breast cancer surgery, on upper extremity dysfunction.

Patients who underwent surgery and axillary lymph node dissection will participate in the study. The cases will be randomly divided into three groups. Conventional upper extremity exercises will be planned for the cases in Group 1, telerehabilitation based supervised exercise will be planned for the cases in Group 2, and mobile application-supported exercise treatment will be planned for the cases in Group 3.

In all groups, exercise side effects such as pain, discomfort, and lymphedema development will be monitored by the physiotherapist, with a weekly face to face meeting with the standard physiotherapy exercise group, and with a phone call every 7-10 days with the telerehabilitation and mobile application supported exercise group. Patients who experience adverse effects during or after treatment will be recorded and necessary precautions will be taken.

Treatment program; It will be carried out twice a week for 6 weeks. Each session is scheduled to be approximately 40-45 minutes. Evaluations will be made before and after the application.

Enrollment

45 patients

Sex

Female

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Being diagnosed with breast cancer and undergoing surgery and having axillary lymph node dissection performed during surgery
  • Finding the cases in the post-operative (post-op) 2nd week
  • Age range between 30 and 65 years
  • Limited shoulder ROM in preoperative evaluations absence
  • No speech or hearing problems
  • Patients included in the study are volunteers

Exclusion criteria

  • Previous ipsilateral or contralateral breast cancer surgery
  • Presence of active or metastatic cancer focus
  • A neurological disease that affects upper extremity functionality or
  • Finding orthopedic surgery
  • Having hearing or visual impairment
  • Carrying a pacemaker
  • Presence of infection and open wound
  • Finding a drain after surgery
  • Cases with mental and cooperation problems

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 3 patient groups

Standard Physiotherapy Exercise Group
Active Comparator group
Description:
The exercise protocol will transition from simple to difficult as a result of literature research, and a standard exercise program will be applied, each session lasting 45 minutes.
Treatment:
Other: Standard Physiotherapy Exercise Group
Telerehabilitation Based Supervised Exercise Group
Active Comparator group
Description:
Telerehabilitation exercise protocol exercises will last 45 minutes in total, transitioning from simple to difficult, and will be implemented with patients via Zoom.
Treatment:
Other: Telerehabilitation Based Supervised Exercise Group
Mobile Application Supported Exercise Group
Active Comparator group
Description:
In the Mobile Application-Based exercise group, a virtual clinic will be created for the patients through the Becure application, and the patients will apply a gradual exercise program that will last approximately 45 minutes, determined by the physiotherapist, and the patients will be followed for 6 weeks through this application.
Treatment:
Other: Mobile Application Supported Exercise Group

Trial contacts and locations

1

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Central trial contact

Begüm Büyükerik

Data sourced from clinicaltrials.gov

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