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

NCT07019311 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005215
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Mastectomy Lymphedema

Outcome Measures

Primary Outcomes (3)

• Center of Pressure (COP)

  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.

  8 weeks

• Total Force (Weight)

  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.

  8 weeks

• Load Distribution

  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.

  8 weeks

Secondary Outcomes (1)

• Limb volume measurement

  8 weeks

Study Arms (2)

Thera-Band exercises + Traditional physical therapy program

EXPERIMENTAL

This group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Thera-Band resistance exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks.

Other: Thera-Band exercises; Other: Traditional physical therapy program

Swiss ball exercises + Traditional physical therapy program

EXPERIMENTAL

This group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Swiss ball exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks.

Other: Swiss ball exercises; Other: Traditional physical therapy program

Interventions

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.

Thera-Band exercises + Traditional physical therapy program

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.

Swiss ball exercises + Traditional physical therapy program

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.

Swiss ball exercises + Traditional physical therapy program; Thera-Band exercises + Traditional physical therapy program

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Damanhour Oncology Center

Damanhūr, Egypt

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammed Mahmoud Abdelkhalek Khalaf

  Professor, Cairo university

  STUDY CHAIR

• Khadra Mohamed Ali

  Assistant Professor, Cairo university

  STUDY DIRECTOR

• Eid Rizk El Gammal

  Assistant Professor, Al-Azhar university

  STUDY DIRECTOR

Central Study Contacts

Afkar Zaki Abdallah Elbabouby, M.Sc

CONTACT

+20 100 331 2524; dr.afkar.albanoby2016@gmail.com

Khadra Mohamed Ali, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: June 11, 2025
• Primary Completion: October 11, 2025
• Study Completion: October 31, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

EG (1)