Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy

NCT ID: NCT06652282

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-08-01

Brief Summary

The purpose of the study was done to evaluate the therapeutic efficacy of Pilates versus PNF in treatment of shoulder dysfunction and limitation of range of motion after mastectomy

Detailed Description

Mastectomy is the removal of the entire breast, with five types: simple or total mastectomy, modified radical mastectomy, radical mastectomy, partial mastectomy, and subcutaneous (nipple-sparing) mastectomy. Post-surgical pain and changes in breast shape can lead to side effects like wound infection, hematoma, seroma, shoulder pain, edema, and decreased range of motion. Mastectomy rates vary worldwide, with the highest rate in central and eastern Europe at 77%. Some women at high risk of breast cancer choose to have a mastectomy even when there's no sign of cancer.

Pilates improve flexibility, build strength, and develop control and endurance in the entire body. It emphasizes alignment, breathing, developing a strong core, and improving coordination and balance. The core, consisting of muscles of the abdomen, low back, and hips, is often called the "powerhouse" and is thought to be the key to a person's stability.

Proprioceptive Neuromuscular Facilitation (PNF) is a stretching technique used to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions.

Conditions

Pilates; Proprioceptive Neuromuscular Fascilitation; Shoulder Dysfunction; Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pilates exercise

This group includes 20 patients who had mastectomy and will recieve Pilates exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises), and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability

Group Type: EXPERIMENTAL

Pilates exercises

Intervention Type: OTHER

Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.

proprioceptive neuromuscular facilitation (PNF)

This group includes 20 patients who had mastectomy and will receive PNF exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability

Group Type: ACTIVE_COMPARATOR

proprioceptive neuromuscular facilitation

Intervention Type: OTHER

Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.

Conventional exercise

This group includes 20 patients who had mastectomy and will receive conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability

Group Type: ACTIVE_COMPARATOR

The conventional program

Intervention Type: OTHER

Each patient was in the supine position and will receive stretching exercise for the flexors and adductors, and strengthening for the extensors, abductors and scapular stabilizers of the affected shoulder

Interventions

Pilates exercises

Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.

Intervention Type: OTHER

proprioceptive neuromuscular facilitation

Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.

Intervention Type: OTHER

The conventional program

Each patient was in the supine position and will receive stretching exercise for the flexors and adductors, and strengthening for the extensors, abductors and scapular stabilizers of the affected shoulder

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Age range between 40-75 years.

• Only females will participate in the study.
• All patients have no diabetes or blood problems.
• All patients enrolled to the study will have their informed consent

Exclusion Criteria

Age less than 40 or more than 75 years.

• Diabetes mellitus.
• Subjects suffering from active malignant tumors.
• Subjects treated with skin graft.
• Subjects with Mental illness.
• Subjects with skin diseases
• Subjects with any previous cause for shoulder dysfunction

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Raafat Ahmed Ali

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

out-patient clinic, faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

Ahmed-005293

Identifier Type: -

Identifier Source: org_study_id