Breast CancerNCT06156397
The Effect of Technological Based Rehabilitation Practices After Breast Cancer Surgery
A study testing Standard Physiotherapy Exercise Group, Telerehabilitation Based Supervised Exercise Group and Mobile Application Supported Exercise Group in people with Breast Cancer, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard Physiotherapy Exercise Group, Telerehabilitation Based Supervised Exercise Group and Mobile Application Supported Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Presence of infection and open wound
- Finding a drain after surgery
- Cases with mental and cooperation problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
The University of Health Sciences Haydarpaşa Numune Hospital
Istanbul, Üsküdar, 34668
About this study
Official title: The Effect of Technological Based Rehabilitation Practices on Functional Parameters After Breast Cancer Surgery
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Standard Physiotherapy Exercise Group, Telerehabilitation Based Supervised Exercise Group, Mobile Application Supported Exercise Group
- Keywords
- rehabilitation, physical therapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physiotherapy Exercise GroupOther
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.
Telerehabilitation Based Supervised Exercise GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Physiotherapy Exercise Group | Active comparator | 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. Receives: Other: Standard Physiotherapy Exercise Group |
| Telerehabilitation Based Supervised Exercise Group | Active comparator | Telerehabilitation exercise protocol exercises will last 45 minutes in total, transitioning from simple to difficult, and will be implemented with patients via Zoom. Receives: Other: Telerehabilitation Based Supervised Exercise Group |
| Mobile Application Supported Exercise Group | Active comparator | 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. Receives: Other: Mobile Application Supported Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Digital Goniometer
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.
Measured: six weeks
Secondary outcomes (7)
Disability of Arm, Shoulder and Hand Questionnaire (DASH)
The Injuries to the Arm, Shoulder, and Hand (DASH) questionnaire was developed by the American Academy of Orthopedic Surgeons to assess upper extremity disability and symptoms. The DASH survey consists of three parts. The first part consists of 30 questions that determine the patient's function - symptom score. The first 21 of these questions evaluate the difficulty the patient experiences in performing daily life activities, 5 questions evaluate upper extremity symptoms (pain, pain that occurs with activity, tingling, weakness and difficulty in movement), and the remaining questions evaluate sleep, work, the patient's self-confidence and social life.
Measured: six weeks
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
The scale is grouped under three subheadings containing 30 questions. Sub-beliefs are the general well-being scale, the functional scale including the subheadings of physical function, general function, cognitive function, mental function and social function, and the symptom consisting of fatigue, pain, stomach brain - enthusiasm, dyspnea, insomnia, fatigue, constipation, diarrhea and material. It includes the scale. The first 28 of the 30 questions in the scale are a four-point Likert type scale and the items are; It is evaluated as Not at all: 1, A little: 2, Quite a bit: 3 or A lot: 4 points. In the 29th and 30th questions of the scale, the patient can be assigned a scale from 1 to 7 (1: Very poor and 7: Excellent), and in the 30th question, a general quality of life evaluation is requested. All scales are scored between 0-100. A high score from the functional scale section indicates good functional status, while a high score from the symptom scale section indicates low vitality.
Measured: six weeks
Muscle Strength Assessment
The upper extremity muscle strength of the subjects will be measured with the J Tech Commander Muscle Tester® manual dynamometer during maximal voluntary isometric muscle contraction. Measurements will be made on the affected and healthy side upper extremities, shoulder flexion and abduction muscle strength in the sitting position, and internal and external rotation muscle strength in the supine position.
Hand grip strength was evaluated with the Saehan Hydraulic Hand Dynamometer. Measurements will be made on the affected side in a sitting position as defined by the American Society of Hand Therapists, shoulder adducted, arm next to the body, elbow 90° flexed, forearm and wrist in neutral position. The results will be recorded in kg and each measurement will be repeated three times. For result measurements, the values will be averaged and a one-minute rest period will be given between measurements.
Measured: six weeks
Tampa Kinesiophobia Scale (TKS)
Individuals' fear of movement levels will be evaluated using the Tampa Kinesiophobia Scale (TKS). TKS is a checklist consisting of 17 questions and was developed to measure fear of movement/re-injury. The scale evaluates fear of movement with a 4-point Likert-type scoring system (1 = I strongly disagree, 4 = I completely agree). 4,8,12,16. While the total score calculated by reversing the questions is determined between 17-68, a higher score means that the person has a greater fear of movement.
Measured: six weeks
Visual Analog Scale (VAS)
VAS is one of the simple and common methods used to evaluate pain intensity. It is a 10 cm long ruler and generally does not have any markings, numbers or writings on it. Patients are asked to mark the appropriate range for their pain at rest and during activity on a 10 cm long chart (0: no pain; 10 is unbearable pain). The point marked by the patients is measured and recorded in millimeters from the left end with the help of a ruler. It is included in the literature as a sensitive and reliable method.
Measured: six weeks
The Global Rating of Change (GRoC)
The Global Rating of Change (GRoC) is a scale that assesses whether the patient condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change, typically following treatment.
Measured: six weeks
The Functional Assessment of Cancer Therapy - Breast (FACT-B)
The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start30 Nov 2023
- Primary completion30 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with a conventional therapy control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begüm Büyükerik, Medipol University
- Investigators
- Begüm Büyükerik, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156397
- Sponsor's protocol ID
- MEDU-FTR-BB-001
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Technological Based Rehabilitation Practices on Functional Parameters After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT06156397
- Acronym / sponsor ID
- MEDU-FTR-BB-001
- Conditions
- Breast Cancer
- Keywords
- rehabilitation, physical therapy, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups with a conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Standard Physiotherapy Exercise Group | Active comparator | Other: Standard Physiotherapy Exercise GroupThe 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. |
| Telerehabilitation Based Supervised Exercise Group | Active comparator | Other: Telerehabilitation Based Supervised Exercise GroupTelerehabilitation exercise protocol exercises will last 45 minutes in total, transitioning from simple to difficult, and will be implemented with patients via Zoom. |
| Mobile Application Supported Exercise Group | Active comparator | Other: Mobile Application Supported Exercise GroupIn 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Physiotherapy Exercise GroupAt 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. | Other | Standard Physiotherapy Exercise Group |
| Telerehabilitation Based Supervised Exercise GroupExercises 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. | Other | Telerehabilitation Based Supervised Exercise Group |
| Mobile Application Supported Exercise GroupWith 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. | Other | Mobile Application Supported Exercise Group |
Primary outcome
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.
7 secondary outcomes
Disability of Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: six weeks
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Time frame: six weeks
Muscle Strength Assessment
Time frame: six weeks
Tampa Kinesiophobia Scale (TKS)
Time frame: six weeks
Visual Analog Scale (VAS)
Time frame: six weeks
The Global Rating of Change (GRoC)
Time frame: six weeks
The Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Begüm Büyükerik principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Physiotherapy Exercise Group, Telerehabilitation Based Supervised Exercise Group and Mobile Application Supported Exercise Group in people with Breast Cancer, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Digital Goniometer (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.