Lung Boost Therapy on Post-mastectomy Postmenopausal

Condition(s) studied

Investigational drug(s) / intervention(s)

Breathing Exercises: Participants will perform a standardized set of breathing and relaxation exercises consisting of: Diaphragmatic breathing (approximately 15 minutes) Pursed-lip breathing (approximately 10 minutes) Relaxation techniques (approximately 5 minutes) Frequency \& Duration: One session daily, 5 sessions per week, for 6 consecutive weeks. Session Length: 30 minutes per session. Provider/Setting: Initial instruction and supervision by a licensed physiotherapist; exercises thereafter performed at home with adherence logs. Safety Monitoring: Participants will be advised to stop if dizziness, chest pain, or unusual shortness of breath occurs, and will report adverse events weekly.

Lung Boost device in addition to Behavioral: Breathing exercises: Intervention Type 1: Device (Respiratory Muscle Training) Intervention Name 1: Lung Boost respiratory muscle trainer Intervention Description 1: Inspiratory/expiratory muscle training using the Lung Boost device. Training parameters: resistance at 30% of maximal inspiratory pressure progressing up to 60% over 6 weeks\]. Frequency \& Duration (Device): 15 minutes per session, once daily, 5 days per week, for 6 weeks. Intervention Type 2: Behavioral (Breathing exercises) Intervention Name 2: Diaphragmatic breathing, Pursed-lip breathing, Relaxation techniques Intervention Description 2: Same standardized breathing and relaxation program as the control group (15 + 10 + 5 minutes). Frequency \& Duration (Exercises): 5 sessions per week, for 6 weeks. Session Length (Exercises): 30 minutes per session. Total Daily Time Commitment: Approximately 45 minutes (15 minutes device + 30 minutes breathing exercises).

Study summary

The goal of this randomized controlled trial is to compare the influences of a traditional pulmonary rehabilitation program versus a combined program including the Lung Boost device on pulmonary function and quality of life in women with compromised respiratory function.

The study will conducted on 50 female participants aged 50-60 years, including post-unilateral mastectomy and postmenopausal cases.

Participants will be randomly assigned into two (2) groups:

* Traditional Group (n=25), will receive conventional breathing exercises and the Lung Boost Group (n=25), will receive the same exercises plus Lung Boost respiratory muscle training.
* Intervention will last 6 weeks 1 session/ day. Pulmonary function parameters (FVC, FEV1, FEV1/FVC, MVV), and quality of life will be assessed pre- and post-treatment.

The main question it aims to answer "Is Lung Boost device has a positive effect on Pulmonary Function in Post-mastectomy Postmenopausal women?" Researchers will compare conventional breathing exercises to Lung Boost respiratory muscle training. to see if Lung Boost device can improve pulmonary function, and quality of life in Post-mastectomy Postmenopausal women.

Eligibility

Primary outcome measure(s)

• Forced Vital Capacity (FVC, L) Forced Expiratory Volume in one second (FEV₁, L) FEV₁/FVC ratio (%) Maximum Voluntary Ventilation (MVV, L/min) — Measurements will be taken at baseline and after 6 weeks of intervention.
  These variables are used to quantify respiratory muscle performance and ventilatory efficiency.

Trial sites (1)

More Ahram Canadian University trials in Egypt