Selected Exercise Program on Upper Cross Syndrome Post-unilateral Mastectomy

NCT07447024 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004071
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the therapeutic efficacy of exercise rehabilitation program on upper limb range and forward head posture post unilateral radical mastectomy.

Conditions

Mastectomy

Outcome Measures

Primary Outcomes (3)

• Craniovertebral angle (CVA)

  The Craniovertebral angle (CVA) is measured by creating an angle between a horizontal line passing through the seventh cervical (C7) vertebra and a line connecting C7 to the tragus of the ear. It is commonly used to assess forward head posture, with smaller angles indicating more severe forward head posture. How to Measure the Craniovertebral Angle: • Use software (KINOVEA) to draw a straight horizontal line passing through C7. Draw a second line connecting the C7 mark to the tragus of the ear. Measure the angle formed by these two lines (the acute angle). * Normal value of CVA: more than 50 degree. * Patients selected with CVA ranged between 30-50 degrees.

  12 weeks

• Cobb angle

  To measure the Cobb angle, identify the most tilted vertebrae at the top and bottom of a scoliosis curve on an X-ray (anteroposterior view). Steps to Measure Cobb Angle: 1. Identify End Vertebrae: Select the highest vertebra (upper end vertebra) and lowest vertebra (lower end vertebra) in the curve that are most tilted toward the concavity. 2. Draw Parallel Lines: * Draw a line parallel to the superior (top) endplate of the upper vertebra. * Draw a line parallel to the inferior (bottom) endplate of the lower vertebra. 3. Draw Perpendicular Lines: Draw a line perpendicular (90 degrees) to each of the lines drawn in step 2. 4. Measure the Angle: The angle formed at the intersection of these two perpendicular lines is the Cobb angle. A curve of more than or equal 10 degrees is defined as scoliosis.

  12 weeks

• The Functional Shoulder Score (FSS)

  The FSS is an 11-item patient-reported subjective outcome questionnaire consisting of two major categories - pain (one question) and activities of daily living (ADLs) (10 questions). Subjects will answer each question on a 10-point numeric rating scale, with a lower number always indicating worse pain or greater difficulty in function. The maximum score of 100 represents the total absence of pain and best possible function. The minimum score of 0 represents the worst possible result. Fifty points will be allocated for pain and 50 for ADLs. The final score will be calculated by multiplying the value indicated by the patient's answer to the question about pain by 5 and adding this to the half the sum of the total value recorded for ADLs.

  12 weeks

Secondary Outcomes (1)

• Functional Assessment of Cancer Therapy-Breast Quality-of- Life Instrument:

  12 weeks

Study Arms (2)

Selected exercise program group

EXPERIMENTAL

Patient will receive exercise program (stretching, strengthening and active range of motion (ROM) exercise) and routine medical treatment for 12 weeks.

Other: Selected exercise program; Drug: Routine medical therapy

Routine medical treatment

ACTIVE COMPARATOR

Patients will receive routine medical treatment only for 12 weeks.

Drug: Routine medical therapy

Interventions

Selected exercise program OTHER

Patients who have upper cross syndrome post unilateral modified radical mastectomy and who will receive exercise program (strengthening, active range of motion exercise, and strengthening exercises including prone scapular stabilization, shoulders shrug McKenzie exercise for neck, repeated shoulder horizontal adduction, repeated shoulder flexion, repeated shoulder extension, neck flexion McKenzie exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12weeks, time of session is 45 minutes.

Also known as: Exercise program

Selected exercise program group

Routine medical therapy DRUG

For pain relief: Acetaminophen: 2 pills two times per day. Ibuprofen 400 mg: 1 pill two times per day. Hormonal therapy: Tamoxifen 20 mg: once daily. Silicone gel creams (Biocorneum): 3 times per day. These medications will be given for all patients throughout the treatment period (12 weeks).

Routine medical treatment; Selected exercise program group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Sixty female patients who have upper cross syndrome post unilateral modified radical mastectomy will participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject selection will be according to the following criteria:
• Age range between 45-65years.
• Females only will participate in the study.
• All patients have upper cross syndrome post-unilateral modified radical mastectomy
• All patients relatives enrolled the study will have their informed consent.

You may not qualify if:

• Age more than 65 years or less than45 years.
• Subjects who have hearing problems
• Patients have acute viral diseases, acute tuberculosis, mental disorders or those with pacemakers.
• Diabetic, cardiac and renal patients.
• Genetic disease
• Patients who had any other breast cancer operations

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Vivian Samy Ayad

Cairo, Egypt

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• George Nashed, Professor

  Cairo University

  STUDY DIRECTOR

• Amal Abd El-Baky, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Vivian Hana, Master

CONTACT

01227288945; viviansamy1983@gmail.com

Ereny Khalil, Professor

CONTACT

01004037190; erenykhalil1986@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): June 7, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

EG (1)