Lung Boost Therapy on Post-mastectomy Postmenopausal

NCT07608042 | Enrolling By Invitation DMC

• 1 other identifier: Ahram Canadian University(ACU)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unilateral Post-mastectomy; Post-menopausal

Keywords

Lung Boost; PostMastectomy; Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Forced Vital Capacity (FVC, L) Forced Expiratory Volume in one second (FEV₁, L) FEV₁/FVC ratio (%) Maximum Voluntary Ventilation (MVV, L/min)

  These variables are used to quantify respiratory muscle performance and ventilatory efficiency.

  Measurements will be taken at baseline and after 6 weeks of intervention.

Secondary Outcomes (3)

• Chest Expansion (cm)

  Measurements will be taken at baseline and after 6 weeks of intervention.

• Functional Assessment of Chronic Illness Therapy-Dyspnea (FACIT-Dyspnea) and FACIT-Functional Limitation scales

  Applied at baseline and after eight weeks of intervention.

• Body mass index (BMI, kg/m^2)

  Applied at baseline and after eight weeks of intervention.

Study Arms (2)

Traditional Group (Control)

EXPERIMENTAL

"Behavioral: Breathing Exercises.

Behavioral: Breathing Exercises

Lung Boost Group ( (Interventional)

ACTIVE COMPARATOR

Device: Lung Boost Respiratory Muscle Trainer" AND "Behavioral: Breathing Exercises."

Behavioral: Breathing Exercises; Device: Lung Boost device in addition to Behavioral: Breathing exercises

Interventions

Breathing Exercises BEHAVIORAL

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 Group ( (Interventional); Traditional Group (Control)

Lung Boost device in addition to Behavioral: Breathing exercises DEVICE

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).

Lung Boost Group ( (Interventional)

Eligibility Criteria

• Age: 50 Years - 60 Years
• Gender Eligibility Details: 50-60 years post-unilateral mastectomy and postmenopausal
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged between 50 -60 years,
• post-unilateral mastectomy cases,
• postmenopausal women,
• Able to perform breathing exercises and use the Lung Boost device, and cooperative
• Capable of providing informed consent.

You may not qualify if:

• Severe cardiopulmonary diseases
• Contraindicating exercise,
• Cognitive impairments preventing device use,
• Current smokers Cases with uncontrolled chronic obstructive pulmonary disease (COPD), and cases unable to comply with the training protocol

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Ahram Canadian University

Giza, Giza Governorate, 3220001, Egypt

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Radwa Mohammed Yehia, Assistant Professor

  Ahram Canadian University

  PRINCIPAL INVESTIGATOR

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: Assistant Professor

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: May 27, 2026
• Study Start: May 20, 2026
• Primary Completion: May 20, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 27, 2026

Record last verified: 2025-09

Locations

EG (1)