NCT06156397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

November 25, 2023

Last Update Submit

December 16, 2025

Conditions

Keywords

rehabilitationphysical therapybreast cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    six weeks

Secondary Outcomes (7)

  • Disability of Arm, Shoulder and Hand Questionnaire (DASH)

    six weeks

  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)

    six weeks

  • Muscle Strength Assessment

    six weeks

  • Tampa Kinesiophobia Scale (TKS)

    six weeks

  • Visual Analog Scale (VAS)

    six weeks

  • +2 more secondary outcomes

Study Arms (3)

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.

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.

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.

Other: Mobile Application Supported Exercise Group

Interventions

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.

Standard Physiotherapy 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.

Telerehabilitation Based Supervised 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.

Mobile Application Supported Exercise Group

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Health Sciences Haydarpaşa Numune Hospital

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Begüm Büyükerik

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups with a conventional therapy control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

November 25, 2023

First Posted

December 5, 2023

Study Start

November 30, 2023

Primary Completion

January 30, 2024

Study Completion

February 15, 2024

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations