Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Comparison of the Effectiveness of Inspiratory Muscle Training and Diaphragmatic Breathing Exercises in Individuals With Generalized Anxiety Disorder
This study will compare inspiratory muscle training and diaphragmatic breathing exercises in individuals with generalized anxiety disorder (GAD). It aims to investigate whether adding either breathing-based intervention to a combined exercise program improves anxiety symptoms and other health-related outcomes compared with adding progressive muscle relaxation.
Participants will be randomly assigned to one of three groups. All groups will receive the same combined exercise program. In addition, the first group will perform inspiratory muscle training, which involves breathing against resistance to strengthen the inspiratory muscles. The second group will perform diaphragmatic breathing exercises, which focus on using the diaphragm during breathing. The third group will receive Jacobson's progressive muscle relaxation technique, which involves systematically tensing and relaxing different muscle groups. All interventions will be delivered over eight weeks using a hybrid telerehabilitation approach combining face-to-face, synchronous online, and independent home-based sessions.
The study will evaluate anxiety symptoms, respiratory muscle strength, pulmonary function, functional exercise capacity, dyspnea, quality of life, depression symptoms, and heart rate variability. The findings may provide further evidence on the comparative effects of these interventions when added to a combined exercise program in individuals with GAD.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Generalized anxiety disorder (GAD) is characterized by persistent and excessive anxiety that may adversely affect individuals' daily functioning and quality of life. Although pharmacological and psychological treatments are commonly used, complementary approaches targeting respiratory function and physical activity may provide additional benefits.
This three-arm, parallel-group randomized controlled trial will compare inspiratory muscle training (IMT) and diaphragmatic breathing exercises with Jacobson's progressive muscle relaxation (PMR) in individuals with GAD. The study is designed to investigate the effects of these interventions when added to a standardized combined exercise program.
All participants will follow the same eight-week combined aerobic and resistance exercise program, consisting of three sessions per week. In addition, participants will be allocated to one of three intervention groups:
Group 1 - Inspiratory Muscle Training: Participants will perform IMT using a threshold-based inspiratory muscle training device. The training load will be adjusted progressively throughout the intervention period.
Group 2 - Diaphragmatic Breathing Exercises: Participants will perform structured diaphragmatic breathing exercises focusing on controlled breathing and diaphragmatic activation.
Group 3 - Active Control: Participants will perform Jacobson's progressive muscle relaxation technique, involving systematic contraction and relaxation of different muscle groups.
The interventions will be delivered using a hybrid telerehabilitation model consisting of one face-to-face session, one synchronous online session, and one independent home-based session per week. This approach will provide a combination of supervised and home-based intervention sessions while maintaining comparable therapist contact across groups.
All clinical and physiological assessments will be conducted face-to-face at baseline and following completion of the eight-week intervention.
The study aims to contribute to the evidence regarding respiratory-based physiotherapy interventions in GAD and to explore the feasibility of integrating these approaches into hybrid telerehabilitation programs.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Nergis Yılmaz
- Telefoonnummer: 05318549782
- E-mail: nergis-yilmaz39@hotmail.com
Studie Locaties
-
-
Uskudar
-
Istanbul, Uskudar, Turkije (Türkiye), 34668
- Werving
- Sultan 2.Abdulhamid Khan Educational and Research Hospital
-
Contact:
- Nergis Yılmaz
- E-mail: nergisyilmaz370@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Diagnosis of generalized anxiety disorder (GAD) by a psychiatrist according to DSM-5 criteria.
A score of 10 or higher on the Generalized Anxiety Disorder-7 (GAD-7) scale. Receiving clinically stable pharmacological treatment. Aged 18-65 years. No condition that prevents the use of a smartphone or access to the internet.
Exclusion Criteria:
Severe pulmonary diseases (e.g., chronic obstructive pulmonary disease [COPD] or an asthma attack) or cardiac diseases (e.g., unstable angina).
A primary psychiatric diagnosis other than generalized anxiety disorder. Orthopedic or neurological limitations that prevent exercise. Severe cardiovascular disease. Pregnancy. Substance use disorder. Recent abdominal or thoracic surgery.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Inspiratory Muscle Training Group
Participants in this group will receive inspiratory muscle training in addition to the common combined exercise program. |
Inspiratory muscle training will be performed using a pressure-threshold device. Training will begin at 30% of maximum inspiratory pressure, with the load increased by 5% per week. Each session will consist of two sets of 30 inspiratory efforts. |
|
Experimenteel: Diaphragmatic Breathing Exercise Group
Participants in this group will perform diaphragmatic breathing exercises in addition to the common combined exercise program. |
Participants will perform structured diaphragmatic breathing exercises according to the study protocol. |
|
Actieve vergelijker: Progressive Muscle Relaxation Group -
Participants in this group will perform progressive muscle relaxation in addition to the common combined exercise program. |
Participants will perform progressive muscle relaxation according to the study protocol. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Anxiety Severity Measured by the GAD-7
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Anxiety severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire assessing anxiety symptoms over the previous two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. The change in total score from baseline to the end of the intervention will be evaluated. |
Baseline (week 1) and at the end of the intervention (week 8).
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Forced Vital Capacity (FVC)
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Pulmonary function will be assessed using spirometry. Forced vital capacity (FVC), representing the maximum volume of air that can be forcibly exhaled after a full inspiration, will be measured in liters (L). |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in Forced Expiratory Volume in One Second (FEV1)
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Pulmonary function will be assessed using spirometry. Forced expiratory volume in one second (FEV1), representing the volume of air forcibly exhaled during the first second, will be measured in liters (L). |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in FEV1/FVC Ratio
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
The FEV1/FVC ratio will be calculated by dividing forced expiratory volume in one second (FEV1) by forced vital capacity (FVC) and will be expressed as a percentage (%). |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in Peak Expiratory Flow (PEF)
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Peak expiratory flow (PEF) will be assessed using spirometry and expressed in liters per second (L/s). |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in Respiratory Muscle Strength
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Respiratory muscle strength will be assessed by measuring maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in Functional Exercise Capacity
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT). The total distance walked will be recorded in meters. |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in Sleep Quality
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in Health-Related Quality of Life
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), which evaluates eight health dimensions. Scores range from 0 to 100, with higher scores indicating better health status. |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in Perceived Dyspnea
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8), during or immediately after the relevant activity or test.
|
Perceived dyspnea will be assessed using the Modified Borg Dyspnea Scale, which ranges from 0 (no breathlessness) to 10 (maximum breathlessness). |
Baseline (week 1) and at the end of the intervention (week 8), during or immediately after the relevant activity or test.
|
|
Change in Anxiety Symptoms Measured by the Beck Anxiety Inventory
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Total scores range from 0 to 63, with higher scores indicating more severe anxiety symptoms. |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in Depressive Symptoms
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. |
Baseline (week 1) and at the end of the intervention (week 8).
|
|
Change in Heart Rate Variability (RMSSD)
Tijdsspanne: Baseline (week 1) and at the end of the intervention (week 8).
|
Heart rate variability will be assessed using the root mean square of successive differences (RMSSD) derived from R-R intervals recorded with a Polar H10 heart rate sensor. Recordings will be obtained during a 5-minute resting period under standardized conditions and analyzed using Kubios HRV Standard software. |
Baseline (week 1) and at the end of the intervention (week 8).
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IMT-GAD-2026-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .