Generalized Anxiety Disorder (GAD)NCT07913503
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
A study testing Inspiratory Muscle Training, Diaphragmatic Breathing Exercises and Progressive Muscle Relaxation in people with Generalized Anxiety Disorder (GAD), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- What is being tested?
- Inspiratory Muscle Training, Diaphragmatic Breathing Exercises and Progressive Muscle Relaxation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Sep 2026to 20 Apr 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan 2.Abdulhamid Khan Educational and Research Hospital
Istanbul, Uskudar, 34668
Nergis Yılmaz, nergisyilmaz370@gmail.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Generalized Anxiety Disorder (GAD)
- Being tested
- Inspiratory Muscle Training, Diaphragmatic Breathing Exercises, Progressive Muscle Relaxation
- Keywords
- Exercise, Progressive Muscle Relaxation, Inspiratory Muscle Training, Diaphragmatic Breathing, Telerehabilitation
- Medical subject headings
- Generalized Anxiety Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingDevice
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.
Diaphragmatic Breathing ExercisesBehavioural
Participants will perform structured diaphragmatic breathing exercises according to the study protocol.
Progressive Muscle RelaxationBehavioural
Participants will perform progressive muscle relaxation according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Participants in this group will receive inspiratory muscle training in addition to the common combined exercise program. Receives: Device: Inspiratory Muscle Training |
| Diaphragmatic Breathing Exercise Group | Experimental | Participants in this group will perform diaphragmatic breathing exercises in addition to the common combined exercise program. Receives: Behavioral: Diaphragmatic Breathing Exercises |
| Progressive Muscle Relaxation Group - | Active comparator | Participants in this group will perform progressive muscle relaxation in addition to the common combined exercise program. Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Severity Measured by the GAD-7
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.
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Secondary outcomes (12)
Change in Forced Vital Capacity (FVC)
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).
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in Forced Expiratory Volume in One Second (FEV1)
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).
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in FEV1/FVC Ratio
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 (%).
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF) will be assessed using spirometry and expressed in liters per second (L/s).
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in Respiratory Muscle Strength
Respiratory muscle strength will be assessed by measuring maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP).
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in Functional Exercise Capacity
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT). The total distance walked will be recorded in meters.
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in Sleep Quality
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.
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in Health-Related Quality of Life
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.
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in Perceived Dyspnea
Perceived dyspnea will be assessed using the Modified Borg Dyspnea Scale, which ranges from 0 (no breathlessness) to 10 (maximum breathlessness).
Measured: 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
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.
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in Depressive Symptoms
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.
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Change in Heart Rate Variability (RMSSD)
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.
Measured: Baseline (week 1) and at the end of the intervention (week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start17 Sep 2026
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nergis Yılmaz, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913503
- Sponsor's protocol ID
- IMT-GAD-2026-001
- Status last verified
- Nov 2026
- First submitted
- 19 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Inspiratory Muscle Training and Diaphragmatic Breathing Exercises in Individuals With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT07913503
- Acronym / sponsor ID
- IMT-GAD-2026-001
- Conditions
- Generalized Anxiety Disorder (GAD)
- Keywords
- Exercise, Progressive Muscle Relaxation, Inspiratory Muscle Training, Diaphragmatic Breathing, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 3 Nov 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Device: Inspiratory Muscle TrainingParticipants in this group will receive inspiratory muscle training in addition to the common combined exercise program. |
| Diaphragmatic Breathing Exercise Group | Experimental | Behavioral: Diaphragmatic Breathing ExercisesParticipants in this group will perform diaphragmatic breathing exercises in addition to the common combined exercise program. |
| Progressive Muscle Relaxation Group - | Active comparator | Behavioral: Progressive Muscle RelaxationParticipants in this group will perform progressive muscle relaxation in addition to the common combined exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Inspiratory Muscle TrainingInspiratory 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. | Device | Inspiratory Muscle Training Group |
| Diaphragmatic Breathing ExercisesParticipants will perform structured diaphragmatic breathing exercises according to the study protocol. | Behavioural | Diaphragmatic Breathing Exercise Group |
| Progressive Muscle RelaxationParticipants will perform progressive muscle relaxation according to the study protocol. | Behavioural | Progressive Muscle Relaxation Group - |
Primary outcome
Change in Anxiety Severity Measured by the GAD-7
Time frame: 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.
12 secondary outcomes
Change in Forced Vital Capacity (FVC)
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in FEV1/FVC Ratio
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in Peak Expiratory Flow (PEF)
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in Respiratory Muscle Strength
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in Functional Exercise Capacity
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in Sleep Quality
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in Health-Related Quality of Life
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in Perceived Dyspnea
Time frame: 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
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in Depressive Symptoms
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
Change in Heart Rate Variability (RMSSD)
Time frame: Baseline (week 1) and at the end of the intervention (week 8).
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training, Diaphragmatic Breathing Exercises and Progressive Muscle Relaxation in people with Generalized Anxiety Disorder (GAD), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Nov 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 Turkey (Türkiye). 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?
Contact Nergis Yılmaz (05318549782, nergis-yilmaz39@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Severity Measured by the GAD-7 (time frame: Baseline (week 1) and at the end of the intervention (week 8).). 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 3 Nov 2026.