Overview
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.
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.
Eligibility
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.
