Unilateral Post-mastectomyNCT07608042
Lung Boost Therapy on Post-mastectomy Postmenopausal
A study testing Breathing Exercises and Lung Boost device in addition to Behavioral: Breathing exercises in people with Unilateral Post-mastectomy and Post-menopausal, run by Ahram Canadian University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Unilateral Post-mastectomy, Post-menopausal
- What is being tested?
- Breathing Exercises and Lung Boost device in addition to Behavioral: Breathing exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Breathing New Life: The Impact of Lung Boost Therapy on Pulmonary Function in Post-mastectomy Postmenopausal Women
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.
Read more
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.
Read the 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.
- Conditions
- Unilateral Post-mastectomy, Post-menopausal
- Being tested
- Breathing Exercises, Lung Boost device in addition to Behavioral: Breathing exercises
- Keywords
- Lung Boost, PostMastectomy, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExercisesBehavioural
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 exercisesDevice
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 group | Role | What they receive |
|---|---|---|
| Traditional Group (Control) | Experimental | "Behavioral: Breathing Exercises. Receives: Behavioral: Breathing Exercises |
| Lung Boost Group ( (Interventional) | Active comparator | Device: Lung Boost Respiratory Muscle Trainer" AND "Behavioral: Breathing Exercises." Receives: Behavioral: Breathing Exercises; Device: Lung Boost device in addition to Behavioral: Breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements will be taken at baseline and after 6 weeks of intervention.
Secondary outcomes (3)
Chest Expansion (cm)
Assessed using a measuring tape at the level of the xiphoid process to determine thoracic mobility during maximal inspiration and expiration.
Measured: 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
Quality of Life sacles using to assess the impact of respiratory limitations on daily activities and overall well-being.
Measured: Applied at baseline and after eight weeks of intervention.
Body mass index (BMI, kg/m^2)
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})
Measured: Applied at baseline and after eight weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start20 May 2026
- Primary completion20 May 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Post-mastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Mohammed Yehia, Ahram Canadian University
- Investigators
- Radwa Mohammed Yehia, Assistant Professor, Principal investigator, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608042
- Sponsor's protocol ID
- Ahram Canadian University(ACU)
- Status last verified
- Sep 2025
- First submitted
- 2 Oct 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing New Life: The Impact of Lung Boost Therapy on Pulmonary Function in Post-mastectomy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07608042
- Acronym / sponsor ID
- Ahram Canadian University(ACU)
- Conditions
- Unilateral Post-mastectomy, Post-menopausal
- Keywords
- Lung Boost, PostMastectomy, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Group (Control) | Experimental | Behavioral: Breathing Exercises"Behavioral: Breathing Exercises. |
| Lung Boost Group ( (Interventional) | Active comparator | Behavioral: Breathing Exercises, Device: Lung Boost device in addition to Behavioral: Breathing exercisesDevice: Lung Boost Respiratory Muscle Trainer" AND "Behavioral: Breathing Exercises." |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing ExercisesParticipants 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. | Behavioural | Lung Boost Group ( (Interventional), Traditional Group (Control) |
| Lung Boost device in addition to Behavioral: Breathing exercisesIntervention 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). | Device | Lung Boost Group ( (Interventional) |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Radwa Mohammed Yehia, Assistant Professor principal investigator
Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercises and Lung Boost device in addition to Behavioral: Breathing exercises in people with Unilateral Post-mastectomy and Post-menopausal, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.