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Enrolling by Invitation

NCT Number: NCT07608042

Lung Boost Therapy on Post-mastectomy Postmenopausal

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.

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Key information

Conditions

Unilateral Post-mastectomy Post-menopausal

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahram Canadian University

Giza, Giza Governorate, 3220001, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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).

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)

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

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

Secondary outcomes

  1. Chest Expansion (cm)

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

    Assessed using a measuring tape at the level of the xiphoid process to determine thoracic mobility during maximal inspiration and expiration.

  2. 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.

    Quality of Life sacles using to assess the impact of respiratory limitations on daily activities and overall well-being.

  3. Body mass index (BMI, kg/m^2)

    Time frame: Applied at baseline and after eight weeks of intervention.

    Body Mass Index (BMI, kg/m^2) is a screening tool that estimates the total body fat based on height and weight. It is calculated by dividing weight in kilograms by the square of height in meters (BMI = fraction {kg}{m^2})

Sponsors and collaborators

Lead sponsor

Ahram Canadian University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.