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Lung Boost Therapy on Post-mastectomy Postmenopausal

19. Mai 2026 aktualisiert von: Radwa Mohammed Yehia, Ahram Canadian University

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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Ägypten
    • Giza Governorate
      • Giza, Giza Governorate, Ägypten, 3220001
        • Ahram Canadian University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Traditional Group (Control)
"Behavioral: Breathing Exercises.
Verhalten: 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.
Aktiver Komparator: Lung Boost Group ( (Interventional)
Device: Lung Boost Respiratory Muscle Trainer" AND "Behavioral: Breathing Exercises."
Verhalten: 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.

Gerät: 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: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Forced Vital Capacity (FVC, L) Forced Expiratory Volume in one second (FEV₁, L) FEV₁/FVC ratio (%) Maximum Voluntary Ventilation (MVV, L/min)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Chest Expansion (cm)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ahram Canadian University

Ermittler

  • Hauptermittler: Radwa Mohammed Yehia, Assistant Professor, Ahram Canadian University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. Mai 2026

Primärer Abschluss (Geschätzt)

20. Mai 2026

Studienabschluss (Geschätzt)

30. November 2026

Studienanmeldedaten

Zuerst eingereicht

2. Oktober 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Mai 2026

Zuerst gepostet (Tatsächlich)

27. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Mai 2026

Zuletzt verifiziert

1. September 2025

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Ahram Canadian University(ACU)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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