Skip to main content
Clinical Trials/NCT06156397
NCT06156397
Completed
Not Applicable

The Effect of Technological Based Rehabilitation Practices on Functional Parameters After Breast Cancer Surgery

Medipol University1 site in 1 country45 target enrollmentNovember 30, 2023
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Medipol University
Enrollment
45
Locations
1
Primary Endpoint
Baseline Digital Goniometer
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 30, 2023
End Date
February 15, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Begüm Büyükerik

Student

Medipol University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Baseline Digital Goniometer

Time Frame: six weeks

The initial and final shoulder range of motion (ROM) of the patients will be recorded in degrees using a digital goniometer. Shoulder ROM measurements will be measured bilaterally and using a standardized protocol.

Secondary Outcomes

  • Tampa Kinesiophobia Scale (TKS)(six weeks)
  • Disability of Arm, Shoulder and Hand Questionnaire (DASH)(six weeks)
  • Visual Analog Scale (VAS)(six weeks)
  • The Functional Assessment of Cancer Therapy - Breast (FACT-B)(six weeks)
  • Muscle Strength Assessment(six weeks)
  • The Global Rating of Change (GRoC)(six weeks)
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)(six weeks)

Study Sites (1)

Loading locations...

Similar Trials