Clinical trial NCT07019311: Effect of Thera-Band Versus Swiss Ball Exercises on Postural Stability in Post Mastectomy Lymphedema
Official title: Effect of Thera-Band Versus Swiss Ball Exercises on Postural Stability in Post Mastectomy Lymphedema
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Mastectomy Lymphedema
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 64
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effect of Thera-band exercises versus Swiss ball exercises on postural stability in unilateral post mastectomy lymphedema.

Detailed description: The need for this study develops from the lack of information in the published studies about the effectiveness of Thera-band exercises and Swiss ball exercise on balance in unilateral post mastectomy lymphedema.

Lymphedema is a chronic and progressive condition associated with functional impairment of the body segment.

The asymmetry between hemi Corp related to the range of motion, muscle strength, sensory stimuli and volume, reduce the ability to perceive and integrate information on the maintenance of the center of gravity and postural balance.

The damage in the balance of patients with breast cancer is pointed out in the literature and is related to factors related to surgical intervention, adjuvant treatment, or even unilateral asymmetry caused by upper limb lymphedema.

Core stability exercises improve neuromuscular system performance that causes the optimal lumbar-pelvic -hip chain mobility and good acceleration and deceleration, appropriate muscular balance, proximal stability and good function.

Progressive resistance training interventions designed to increase strength and reduce the falls in elderly were effective in reducing both rate of falls and risk of falling, especially when some form of balance exercise was an integral part of the program.

The present study is designed to investigate the effect of Thera-band exercises versus Swiss ball exercises on balance in unilateral post mastectomy lymphedema.

Eligibility criteria: Inclusion Criteria:

* Patients are females.
* Patient with post mastectomy unilateral lymphedema.
* Their age will range from (30-50) years.
* Patients will be given their informed consent.

Exclusion Criteria:

* Musculoskeletal disorders that will impair performance during training and tests.
* Uncontrolled cardiovascular or pulmonary diseases.
* Neurological and renal disorders.
* Metabolic or vascular disease with a neurological component such as diabetes.
* Malignant conditions.
* Primary lymphedema.
* Psychiatric illness, severe behavior or cognitive disorders.
* Uncooperative patients.
* Pregnancy.

Primary outcomes:
measure: Center of Pressure (COP)
timeFrame: 8 weeks
measure: Total Force (Weight)
timeFrame: 8 weeks
measure: Load Distribution
timeFrame: 8 weeks
Secondary outcomes:
measure: Limb volume measurement
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Oncology Center
Study officials:
affiliation: Professor, Cairo university
name: Mohammed Mahmoud Abdelkhalek Khalaf
role: STUDY_CHAIR
affiliation: Assistant Professor, Cairo university
name: Khadra Mohamed Ali
role: STUDY_DIRECTOR
affiliation: Assistant Professor, Al-Azhar university
name: Eid Rizk El Gammal
role: STUDY_DIRECTOR
References: