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

NCT ID: NCT07019311

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-11
• Study Completion Date: 2025-10-31

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.

Conditions

Post Mastectomy Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thera-Band exercises + Traditional physical therapy program

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.

Group Type: EXPERIMENTAL

Thera-Band exercises

Intervention Type: 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.

Traditional physical therapy program

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Swiss ball exercises

Intervention Type: 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

Intervention Type: 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.

Interventions

Thera-Band exercises

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.

Intervention Type: OTHER

Swiss ball exercises

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.

Intervention Type: OTHER

Traditional physical therapy program

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Afkar Zaki Abdullah Elbanouby

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed Mahmoud Abdelkhalek Khalaf

Role: STUDY_CHAIR

Professor, Cairo university

Khadra Mohamed Ali

Role: STUDY_DIRECTOR

Assistant Professor, Cairo university

Eid Rizk El Gammal

Role: STUDY_DIRECTOR

Assistant Professor, Al-Azhar university

Locations

Damanhour Oncology Center

Damanhūr, , Egypt

Countries

Egypt

Central Contacts

Afkar Zaki Abdallah Elbabouby, M.Sc

Role: CONTACT

dr.afkar.albanoby2016@gmail.com

+20 100 331 2524

Khadra Mohamed Ali, PhD

Role: CONTACT

Facility Contacts

Afkar Zaki Abdallah Elbabouby, M.Sc

Role: primary

dr.afkar.albanoby2016@gmail.com

+20 100 331 2524

Other Identifiers

P.T.REC/012/005215

Identifier Type: -

Identifier Source: org_study_id