Lung Boost Therapy on Post-mastectomy Postmenopausal

Official title

Breathing New Life: The Impact of Lung Boost Therapy on Pulmonary Function in Post-mastectomy Postmenopausal Women

Overview

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.

Detailed description

This randomized controlled trial aims to evaluate and compare the effects of a conventional pulmonary rehabilitation program versus a combined intervention incorporating the Lung Boost device on pulmonary function and quality of life among women with impaired respiratory function.

The study will include fifty (50) female participants aged between 50 and 60 years who have undergone unilateral mastectomy and are in the postmenopausal stage. Participants will be randomly allocated into two equal groups. The Traditional Group (n=25) will receive standard pulmonary rehabilitation consisting of conventional breathing exercises, while the Lung Boost Group (n=25) will receive the same regimen supplemented with respiratory muscle training using the Lung Boost device.

The intervention period will extend over six weeks, with sessions conducted once daily. Outcomes will be assessed both before and after the intervention. Pulmonary function will be evaluated through spirometric measurements, including forced vital capacity (FVC), forced expiratory volume in one second (FEV₁), the FEV₁/FVC ratio, and maximum voluntary ventilation (MVV). In addition, quality of life will be assessed using a validated questionnaire appropriate for the target population.

The study seeks to determine whether the inclusion of the Lung Boost device within a structured pulmonary rehabilitation program yields significant improvements in pulmonary function and overall quality of life in postmastectomy, postmenopausal women with compromised respiratory performance, compared with conventional breathing exercises alone.

Interventions

• Behavioral 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 w
• Device 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: D

Primary outcome measures

• Forced Vital Capacity (FVC, L) Forced Expiratory Volume in one second (FEV₁, L) FEV₁/FVC ratio (%) Maximum Voluntary Ventilation (MVV, L/min) [Time frame: Measurements will be taken at baseline and after 6 weeks of intervention.]

Secondary outcome measures (3)

• Chest Expansion (cm) [Time frame: 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 [Time frame: Applied at baseline and after eight weeks of intervention.]
• Body mass index (BMI, kg/m^2) [Time frame: Applied at baseline and after eight weeks of intervention.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Ahram Canadian University — Giza

Identifiers

NCT: NCT07608042 · Ahram Canadian University(ACU)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗