Lung Boost Therapy on Post-mastectomy Postmenopausal
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.
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypt, 3220001
- Ahram Canadian University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Traditional Group (Control)
"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 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. |
|
Aktivní komparátor: Lung Boost Group ( (Interventional)
Device: Lung Boost Respiratory Muscle Trainer" AND "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 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. 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). |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Forced Vital Capacity (FVC, L) Forced Expiratory Volume in one second (FEV₁, L) FEV₁/FVC ratio (%) Maximum Voluntary Ventilation (MVV, L/min)
Časové okno: Measurements will be taken at baseline and after 6 weeks of intervention.
|
These variables are used to quantify respiratory muscle performance and ventilatory efficiency.
|
Measurements will be taken at baseline and after 6 weeks of intervention.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Chest Expansion (cm)
Časové okno: 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.
|
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
Časové okno: 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.
|
Applied at baseline and after eight weeks of intervention.
|
|
Body mass index (BMI, kg/m^2)
Časové okno: 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})
|
Applied at baseline and after eight weeks of intervention.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Radwa Mohammed Yehia, Assistant Professor, Ahram Canadian University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Ahram Canadian University(ACU)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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