The Effect of Technological Based Rehabilitation Practices After Breast Cancer Surgery

NCT ID: NCT06156397

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-02-15

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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rehabilitation physical therapy breast cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups with a conventional therapy control group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Telerehabilitation Based Supervised Exercise Group

Telerehabilitation exercise protocol exercises will last 45 minutes in total, transitioning from simple to difficult, and will be implemented with patients via Zoom.

Group Type ACTIVE_COMPARATOR

Telerehabilitation Based Supervised Exercise Group

Intervention Type OTHER

Exercises will be performed for 45 minutes, twice a week, for a total of 12 sessions, for a total of 6 weeks. In the telerehabilitation group, breathing exercises, upper extremity pumping exercises, scar tissue massage and flexion movements up to 90 degrees will be applied for the first 2 weeks at the beginning of the treatment, through a meeting with the patients via zoom application. 2-6. Between weeks, pendulum exercise, shoulder rotation, lifting overhead with clasped hands while sitting and lying down, wand exercise, snow angels, clock on the wall exercise, m. Pectoralis minor and major stretching, standing trunk rotation, and scapulo-thoracic joint stabilization exercises will be applied. 6-8. In the following weeks, in addition to the previous exercises, strengthening exercises will be applied in all directions with theraband and weights.

Mobile Application Supported Exercise Group

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.

Group Type ACTIVE_COMPARATOR

Mobile Application Supported Exercise Group

Intervention Type OTHER

With the videos uploaded to the Becure application, breathing exercises, upper extremity pumping exercises, scar tissue massage and flexion movements up to 90 degrees will be applied in the first 2 weeks. 2-6. Between weeks, pendulum exercise, shoulder rotation, lifting overhead with clasped hands while sitting and lying down, wand exercise, snow angels, clock on the wall exercise, m. Pectoralis minor and major stretching, standing trunk rotation, and scapulo-thoracic joint stabilization exercises will be applied. 6-8. Between weeks, in addition to the previous exercises, strengthening exercises will be applied in all directions with theraband and weight. Exercises will start with 2 sets of 5-10 repetitions and progress to 10-15 repetitions.

Standard Physiotherapy Exercise Group

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.

Group Type ACTIVE_COMPARATOR

Standard Physiotherapy Exercise Group

Intervention Type OTHER

At the beginning of the treatment, breathing exercises, upper extremity pumping exercises, scar tissue massage and flexion movements up to 90 degrees will be applied for the first 2 weeks. 2-6. Between weeks, pendulum exercise, shoulder rotation, lifting overhead with clasped hands while sitting and lying down, wand exercise, snow angels, clock on the wall exercise, m. Pectoralis minor and major stretching, standing trunk rotation, and scapulo-thoracic joint stabilization exercises will be applied. 6-8. In the following weeks, in addition to the previous exercises, strengthening exercises will be applied in all directions with theraband and weights. Exercises will start with 2 sets of 5-10 repetitions and progress to 10-15 repetitions. Exercises will be performed for 45 minutes, twice a week, for a total of 12 sessions, for a total of 6 weeks.

Interventions

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Standard Physiotherapy Exercise Group

At the beginning of the treatment, breathing exercises, upper extremity pumping exercises, scar tissue massage and flexion movements up to 90 degrees will be applied for the first 2 weeks. 2-6. Between weeks, pendulum exercise, shoulder rotation, lifting overhead with clasped hands while sitting and lying down, wand exercise, snow angels, clock on the wall exercise, m. Pectoralis minor and major stretching, standing trunk rotation, and scapulo-thoracic joint stabilization exercises will be applied. 6-8. In the following weeks, in addition to the previous exercises, strengthening exercises will be applied in all directions with theraband and weights. Exercises will start with 2 sets of 5-10 repetitions and progress to 10-15 repetitions. Exercises will be performed for 45 minutes, twice a week, for a total of 12 sessions, for a total of 6 weeks.

Intervention Type OTHER

Telerehabilitation Based Supervised Exercise Group

Exercises will be performed for 45 minutes, twice a week, for a total of 12 sessions, for a total of 6 weeks. In the telerehabilitation group, breathing exercises, upper extremity pumping exercises, scar tissue massage and flexion movements up to 90 degrees will be applied for the first 2 weeks at the beginning of the treatment, through a meeting with the patients via zoom application. 2-6. Between weeks, pendulum exercise, shoulder rotation, lifting overhead with clasped hands while sitting and lying down, wand exercise, snow angels, clock on the wall exercise, m. Pectoralis minor and major stretching, standing trunk rotation, and scapulo-thoracic joint stabilization exercises will be applied. 6-8. In the following weeks, in addition to the previous exercises, strengthening exercises will be applied in all directions with theraband and weights.

Intervention Type OTHER

Mobile Application Supported Exercise Group

With the videos uploaded to the Becure application, breathing exercises, upper extremity pumping exercises, scar tissue massage and flexion movements up to 90 degrees will be applied in the first 2 weeks. 2-6. Between weeks, pendulum exercise, shoulder rotation, lifting overhead with clasped hands while sitting and lying down, wand exercise, snow angels, clock on the wall exercise, m. Pectoralis minor and major stretching, standing trunk rotation, and scapulo-thoracic joint stabilization exercises will be applied. 6-8. Between weeks, in addition to the previous exercises, strengthening exercises will be applied in all directions with theraband and weight. Exercises will start with 2 sets of 5-10 repetitions and progress to 10-15 repetitions.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Begüm Büyükerik

Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Begüm Büyükerik

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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The University of Health Sciences Haydarpaşa Numune Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MEDU-FTR-BB-001

Identifier Type: -

Identifier Source: org_study_id