Breast CancerPrehab of BCNCT07240584
Exercise Prehabilitation of Breast Cancer
A study testing Exercise-Based Prehabilitation Program in people with Breast Cancer and Shoulder Dysfunction, run by University of Health Sciences Balikesir Hospital Eduation and Research at 1 site in Turkey (Türkiye).
Trial summary
This prospective prehabilitation trial evaluated the effectiveness of an individualized exercise program initiated before breast cancer surgery and maintained for 12 months. The intervention aimed to promote functional recovery and improve patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Shoulder Dysfunction, Quality of Life
- What is being tested?
- Exercise-Based Prehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 2 Nov 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients diagnosed with breast cancer scheduled for surgical treatment
- Age ≥ 18 years
- Able to perform exercise
- Provided informed consent
Who cannot join
- Metastatic disease
- Prior upper limb injury or neurologic impairment
- Inability to comply with exercise program
- Postoperative chemotherapy before the 3rd month
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir Ataturk City Hospital Affiliated with University of Health Sciences
Balıkesir
About this study
Official title: The Impact of Exercise Prehabilitation on Upper Extremity Range of Motions, Functionality and Quality of Life in Breast Cancer Survivors: A Prospective Clinical Trial
This prospective prehabilitation trial evaluated the effectiveness of an individualized exercise program initiated before breast cancer surgery and maintained for 12 months. The intervention aimed to promote functional recovery and improve patient-reported outcomes.
Read the detailed description
Women scheduled for breast surgery due to breast cancer were enrolled in an individualized prehabilitation program that began in the preoperative period and continued for 12 months. The exercise program included range-of-motion, strengthening, and postural correction exercises delivered through supervised and home-based sessions. Outcomes were evaluated at baseline and at 1st, 3rd, 6th, and 12th months. Functional outcomes, shoulder range of motion, pain intensity, lymphedema development, and patient-reported quality of life were assessed.
- Conditions
- Breast Cancer, Shoulder Dysfunction, Quality of Life, Postoperative Recovery, Fatigue, Lymphedema
- Being tested
- Exercise-Based Prehabilitation Program
- Keywords
- exercise prehabilitation, breast cancer, upper extremity functionality, quality of life
- Medical subject headings
- Breast Neoplasms, Fatigue, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-Based Prehabilitation ProgramBehavioural
The exercise program was delivered to patients through both visual and written materials, accompanied by face-to-face training sessions conducted by a physiotherapist. A home-based program was designed separately for the pre-surgery phase, postoperative day 1, day 3, day 7, and the maintenance period.
The exercise template included postural correction, breathing, aerobic, stretching, and resistive strengthening exercises targeting muscles in adjacent to the shoulder joint and mobilization of scapulothoracic complex via stretching and strengthening exercises of periscapular muscles.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Other | Not described Receives: Behavioral: Exercise-Based Prehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Range of Motion
Measurement of Flexion, Abduction, Internal and External Rotation of Shoulder with goniometer
Measured: baseline, 1st-3rd-6th-12th month
Pain Intensity
measure of pain with VAS (Visual analog scale)
Measured: baseline, 1st-3rd-6th-12th month
Functional Outcomes
measure of upper extremity functions with UEFI-15 (Upper extremity functional index) instrument
Measured: baseline and 12th month
Secondary outcomes (3)
fatigue
measure of fatigue condition with FSS (Fatigue severity scale) instrument
Measured: baseline and 12th month
Quality of Life impairment
measure of Quality of Life with EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire) instrument
Measured: baseline and 12th month
lymphedema
Limb volume difference >10% or clinical signs of edema
Measured: baseline and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start25 Oct 2024
- Primary completion2 Nov 2025
- Study completion2 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and Research
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240584
- Sponsor's protocol ID
- UHS Balikesir H PMR
- Acronym
- Prehab of BC
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brahmbhatt P, Sabiston CM, Lopez C, Chang E, Goodman J, Jones J, McCready D, Randall I, Rotstein S, Santa Mina D. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020 Sep 25;10:571091. doi: 10.3389/fonc.2020.571091. eCollection 2020.
PubMed 33072603Michael CM, Lehrer EJ, Schmitz KH, Zaorsky NG. Prehabilitation exercise therapy for cancer: A systematic review and meta-analysis. Cancer Med. 2021 Jul;10(13):4195-4205. doi: 10.1002/cam4.4021. Epub 2021 Jun 10.
PubMed 34110101Alicia DRJ, Manuel GS, Ignacio CVA. Physical prehabilitation in patients with breast cancer: a systematic review. Support Care Cancer. 2025 Jan 6;33(1):71. doi: 10.1007/s00520-024-09122-w.
PubMed 39757306Akin T, Akin M, Kucuk AI, Iriagac Y. The impact of exercise prehabilitation on upper extremity range of motions, functionality and quality of life in breast cancer survivors: a prospective clinical trial. BMC Sports Sci Med Rehabil. 2026 Jan 29;18(1):122. doi: 10.1186/s13102-026-01534-x.
PubMed 41612417
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exercise Prehabilitation on Upper Extremity Range of Motions, Functionality and Quality of Life in Breast Cancer Survivors: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07240584
- Acronym / sponsor ID
- Prehab of BC / UHS Balikesir H PMR
- Conditions
- Breast Cancer, Shoulder Dysfunction, Quality of Life, Postoperative Recovery, Fatigue, Lymphedema
- Keywords
- exercise prehabilitation, breast cancer, upper extremity functionality, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and ResearchOther government
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 2 Nov 2025 (actual)
- Study completion
- 2 Nov 2025 (actual)
- First posted
- 21 Nov 2025 (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.
This prospective prehabilitation trial evaluated the effectiveness of an individualized exercise program initiated before breast cancer surgery and maintained for 12 months. The intervention aimed to promote functional recovery and improve patient-reported outcomes.
Detailed description
Women scheduled for breast surgery due to breast cancer were enrolled in an individualized prehabilitation program that began in the preoperative period and continued for 12 months. The exercise program included range-of-motion, strengthening, and postural correction exercises delivered through supervised and home-based sessions. Outcomes were evaluated at baseline and at 1st, 3rd, 6th, and 12th months. Functional outcomes, shoulder range of motion, pain intensity, lymphedema development, and patient-reported quality of life were assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Other | Behavioral: Exercise-Based Prehabilitation Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients diagnosed with breast cancer scheduled for surgical treatment
- Age ≥ 18 years
- Able to perform exercise
- Provided informed consent
Key exclusion criteria (4 listed)
- Metastatic disease
- Prior upper limb injury or neurologic impairment
- Inability to comply with exercise program
- Postoperative chemotherapy before the 3rd month
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 |
|---|---|---|
| Exercise-Based Prehabilitation ProgramThe exercise program was delivered to patients through both visual and written materials, accompanied by face-to-face training sessions conducted by a physiotherapist. A home-based program was designed separately for the pre-surgery phase, postoperative day 1, day 3, day 7, and the maintenance period. The exercise template included postural correction, breathing, aerobic, stretching, and resistive strengthening exercises targeting muscles in adjacent to the shoulder joint and mobilization of scapulothoracic complex via stretching and strengthening exercises of periscapular muscles. | Behavioural | Single Group Assignment |
Primary outcome
Shoulder Range of Motion
Time frame: baseline, 1st-3rd-6th-12th month
Measurement of Flexion, Abduction, Internal and External Rotation of Shoulder with goniometer
Pain Intensity
Time frame: baseline, 1st-3rd-6th-12th month
measure of pain with VAS (Visual analog scale)
Functional Outcomes
Time frame: baseline and 12th month
measure of upper extremity functions with UEFI-15 (Upper extremity functional index) instrument
3 secondary outcomes
fatigue
Time frame: baseline and 12th month
Quality of Life impairment
Time frame: baseline and 12th month
lymphedema
Time frame: baseline and 12th month
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 21 Nov 2025.
- Results publication: PubMed 33072603Brahmbhatt P, Sabiston CM, Lopez C, Chang E, Goodman J, Jones J, McCready D, Randall I, Rotstein S, Santa Mina D. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020 Sep 25;10:571091. doi: 10.3389/fonc.2020.571091. eCollection 2020.
- Results publication: PubMed 34110101Michael CM, Lehrer EJ, Schmitz KH, Zaorsky NG. Prehabilitation exercise therapy for cancer: A systematic review and meta-analysis. Cancer Med. 2021 Jul;10(13):4195-4205. doi: 10.1002/cam4.4021. Epub 2021 Jun 10.
- Results publication: PubMed 39757306Alicia DRJ, Manuel GS, Ignacio CVA. Physical prehabilitation in patients with breast cancer: a systematic review. Support Care Cancer. 2025 Jan 6;33(1):71. doi: 10.1007/s00520-024-09122-w.
- Derived from this study: PubMed 41612417Akin T, Akin M, Kucuk AI, Iriagac Y. The impact of exercise prehabilitation on upper extremity range of motions, functionality and quality of life in breast cancer survivors: a prospective clinical trial. BMC Sports Sci Med Rehabil. 2026 Jan 29;18(1):122. doi: 10.1186/s13102-026-01534-x.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-Based Prehabilitation Program in people with Breast Cancer and Shoulder Dysfunction, run by University of Health Sciences Balikesir Hospital Eduation and Research 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 4 inclusion and 4 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 21 Nov 2025. 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?
Shoulder Range of Motion (time frame: baseline, 1st-3rd-6th-12th month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240584, which also lists 4 linked publications.
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 21 Nov 2025.