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NCT Number: NCT07019311

Effect of Thera-Band Versus Swiss Ball Exercises on Postural Stability in Post Mastectomy Lymphedema

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.

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Key information

Conditions

Post Mastectomy Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thera-Band exercises

Other

Participants in the first experimental group performed a Thera-Band exercise program 3 sessions weekly, for 8 weeks with progressive resistance, divided into four 2-week phases. Each 60-minute session included a 10-min warm-up (walking, jogging, and calisthenics), 45-min Thera-Band exercises, and 5-min cool-down. Phase 1 focused on major muscle groups (e.g., shoulder press, biceps curl). Phase 2 included trunk and leg-focused moves (e.g., reverse flies, lunge). Phase 3 added advanced resistance (e.g., chest press, deadlift). Phase 4 targeted core and lower body (e.g., diagonal chop, squat). Exercises changed every phase to progressively strengthen different muscle groups.

Swiss Ball Exercises

Other

Participants in the second experimental group performed Swiss ball exercises 3 sessions weekly, for 8 weeks. Exercises included warm-up (15-5 mins), core Swiss ball training (progressing from 1 to 4 sets), and cool-down. Each session focused on abdominal, back, leg, trunk, and balance training using varied exercises performed for 30 seconds with rest. Exercise intensity ranged from 80-95% of max effort, increasing weekly. The Swiss ball size was selected based on patient height to ensure proper posture. Sessions gradually increased in duration and difficulty, ending with breathing and stretching for recovery.

Traditional physical therapy program

Other

Participants in both experimental groups performed a traditional physical therapy program in the form of complex decongestive physical therapy(CDPT), including (manual lymphatic drainage, compression, exercise and skin care) and balance training, 3 sessions weekly, for 8 weeks.

Primary outcomes

  1. Center of Pressure (COP)

    Time frame: 8 weeks

    The Wii Balance Board (WBB) will be used to measure the Center of Pressure (COP), which represents the point location of the vertical ground reaction force vector. This outcome reflects the user's weight distribution and is a key indicator of balance and postural control. COP will be assessed in both the mediolateral (X-axis: left-right) and anteroposterior (Y-axis: front-back) directions, allowing evaluation of postural sway and dynamic weight shifting during balance tasks.

  2. Total Force (Weight)

    Time frame: 8 weeks

    Total vertical ground reaction force will be calculated by summing the readings from all four pressure sensors on the WBB. This measure provides an estimate of the user's body weight and enables monitoring of force fluctuations during dynamic or static postural tasks, serving as an indirect marker of load-bearing and movement initiation or compensation patterns.

  3. Load Distribution

    Time frame: 8 weeks

    The WBB will quantify the distribution of body weight across the left vs. right and front vs. back regions of the platform. This load distribution outcome helps identify asymmetries in stance or postural alignment, which can be critical in populations with balance deficits or musculoskeletal impairments. The measure allows for detailed analysis of postural strategy and weight-bearing preference.

Secondary outcomes

  1. Limb volume measurement

    Time frame: 8 weeks

    Limb volume will be measured using the truncated cone method with circumferential measurements taken at 10-cm intervals (at 0, 10, 20, 30, and 40 cm from the ulnar styloid). The patient will be seated with the limb supported horizontally on a bedside table. A 1-cm retractable fiberglass tape will be used, and an adhesive measuring strip from axilla to wrist will ensure consistency. Segment volume will be calculated using the formula: V = h × (C1² + C1×C2 + C2²) / (12π), where C1 and C2 are the circumferences and h is the 10 cm distance between them.

Study contacts

Contact information is provided by the study sponsor or research team.

Afkar Zaki Abdallah Elbabouby, M.Sc

CONTACT

[email protected]

+20 100 331 2524

Khadra Mohamed Ali, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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