Clinical trial NCT06848608: Comparison of the Effects of Yoga and Conventional Physiotherapy Programs in Sarcoidosis
Official title: Comparison of the Effects of Yoga and Conventional Physiotherapy Programs on Fatigue, Pulmonary Functions and Exercise Capacity in Patients With Sarcoidosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoidosis
Pulmonary Rehabilitation
Yoga
Keywords: pulmonary rehabilitation
sarcoidosis
yoga
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
Collaborators: name: Istanbul Saglik Bilimleri University
name: Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
First posted: 2025-02-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sarcoidosis is a multisystem disease, characterized by the formation of immune granulomas with various clinical symptoms depending on the involved organs, which can involve many organs and systems associated with emotional and physical consequences that affect the quality of life, whose cause is unknown, but usually affects the respiratory system, and occurs mostly in young and middle-aged adults. Lung involvement, seen in 95% of patients, causes limitation of lung capacity and decrease in inspiratory muscle strength, which are important factors that lead to an increase in dyspnea and a decrease in walking distance. In addition to respiratory muscle weakness, skeletal muscle dysfunction is also frequently observed. The most common symptoms in sarcoidosis are dyspnea and fatigue. When the current literature is examined, it can be seen that studies on non-pharmacological treatment methods in Sarcoidosis are quite limited. Although relatively common in Chronic Obstructive Pulmonary Disease (COPD), various studies conducted in patients with Bronchiectasis, Pulmonary Arterial Hypertension and Asthma have shown that yoga results in a decrease in dyspnea and fatigue, and an increase in pulmonary functions and exercise capacity. On the other hand, no study has been found on yogic techniques in Sarcoidosis. Aim of this study is to investigate the effects of yogic techniques and conventional physiotherapy program on pulmonary functions, body oxygen level test (BOLT), exercise capacity (6MWT), anxiety, depression, fatigue, dyspnea perception, sleep quality, and quality of life in sarcoidosis cases at different stages. In these patients known to have multisystem involvement, holistic approaches gain importance due to the nature of the disease.

Detailed description: Sarcoidosis is a multisystem disease that can involve many organs and systems, is characterized by the formation of immune granulomas with various clinical symptoms depending on the involved organs, has an unknown cause, but generally affects the respiratory system, and occurs mostly in young and middle-aged adults. Lung involvement, seen in 95% of patients, causes limitation of lung capacity and decrease in inspiratory muscle strength, which are important factors that lead to an increase in dyspnea and a decrease in walking distance. In addition to respiratory muscle weakness, skeletal muscle dysfunction is also frequently observed. The most common symptoms in sarcoidosis are dyspnea and fatigue. Sarcoidosis is a chronic disease associated with emotional and physical consequences that affect quality of life. Psychiatric disorders such as depression and anxiety are more common in patients diagnosed with sarcoidosis than in the general population. Dyspnea, fatigue, respiratory and skeletal muscle weakness observed in patients cause a decrease in quality of life. It is stated that 50% of patients experience sleep disorders and this situation is accompanied by fatigue, anxiety, depression and a decrease in quality of life. The positive effects of exercise training, which is the most important part of multidisciplinary rehabilitation programs in chronic lung diseases, on exercise capacity, dyspnea and fatigue perception, and quality of life in chronic obstructive pulmonary patients have been proven in numerous studies. Respiratory rehabilitation is believed to be an effective treatment method in interstitial lung patients, who often present with restrictive respiratory disorder, due to problems such as increased dyspnea, limitation in exercise capacity, fatigue, anxiety, depression, and low quality of life. This idea is supported by studies showing that pulmonary rehabilitation improves exercise capacity, perception of dyspnea, and quality of life in patients with interstitial lung. Although aerobic and resistance exercise programs are recommended for interstitial lung patients because they increase peripheral muscle strength and tone, the optimal exercise prescription is not yet known. Studies have shown that exercise prescriptions were prepared similarly for COPD patients, and some changes may be required in those with severe disease. Since interstitial lung disease includes many different groups of chronic lung diseases, there is a need for recommendations to consider these different groups in pulmonary rehabilitation practices. Information about the effectiveness of pulmonary rehabilitation programs for sarcoidosis, which is included in the group of interstitial lung diseases, is very limited. According to the guideline published by ERS in 2021, a 6-12 week pulmonary rehabilitation program (at low level of evidence) was recommended for patients with sarcoidosis and fatigue without exercise contraindications to relieve fatigue. It is accepted that the exercise training program applied to sarcoidosis patients provides an increase in exercise capacity and a decrease in fatigue. It has been observed that respiratory exercises applied together with dynamic upper extremity and trunk exercises in young adults provide an improvement in pulmonary functions and it has been stated that these exercises should be added to the treatment program of patients requiring respiratory therapy due to their beneficial effects. Chest wall mobility affects lung functions. Decreased chest wall compliance, especially expansion of the rib cage, leads to atrophy of the diaphragm as well as the intercostal muscles. This can lead to immobility in the thorax, dyspnea and inadequate spontaneous breathing. Thoracic expansion exercises that increase chest wall mobility in individuals with chronic obstructive pulmonary disease have been observed to result in a significant clinical improvement in expired tidal volume, a decrease in dyspnea and an increase in thoracic expansion. Yoga is a combination of asanas, breathing techniques and meditation components and is a suitable approach for cardiopulmonary rehabilitation programs because it regulates autonomic function by increasing vagal nerve activation. Yoga, which increases nitric oxide bioavailability, helps improve endothelial function. Pranayama techniques, which refer to yogic breathing exercises, have been shown to improve pulmonary function in patients with coronary artery disease. Pranayama, which is based on diaphragm techniques, also has positive effects on depression, anxiety, sleep and quality of life. Due to its close connection with the solar plexus, slow and deep breathing activities and asanas performed with diaphragm activation also have beneficial effects in terms of controlling different physical functions and emotional states. Pranayama balances the autonomic nervous system through the tension-related inhibitory stimulations of the nerve endings in the nose and especially the diaphragm. The breathing pattern affects the heart, brain and nervous system and is linked to anxiety. In stressful situations, shorter, more frequent and shallow breathing occurs. The first aim of pranayama is to slow down the respiratory rhythm. Slow and deep breathing reduces stress levels and Partial Arterial Carbon Dioxide Pressure (PaCO2) in the lungs and blood vessels through autonomic reflex stimulation. Parasympathetic nervous system activity is decreased in sarcoidosis patients. During the inspiratory phase of slow pranayamic breathing; "slowly adapting tension receptors" belonging to the lung tissues and sending their signals to dorsal respiratory neurons via the vagal nerve are activated and create inhibitory stimuli in the neural tissue (Hering Breuer reflex). These inhibitory stimuli play an important role in the regulation of airway smooth muscle tone, respiratory pattern, heart rate and systemic vascular resistance. In addition, the tension in the connective tissues around the lungs affects the membrane potential and causes hyperpolarization. Therefore, the inhibitory stimuli and hyperpolarization currents that occur in neural and non-neural tissues as a result of mechanical stretching of the tissues during slow pranayamic breathing exercises lead to modulation of the nervous system and parasympathetic activation. Sarcoidosis patients are generally monitored for a period deemed appropriate by the specialist doctor and do not receive treatment if there is no progression in the disease during this period. Sarcoidosis is mainly treated with cortisone and immunosuppressive drugs that suppress the immune system's response. However, it has been stated that long-term cortisone use can have side effects and can also cause the disease to reoccur. When the current literature is examined, it is seen that studies on non-pharmacological treatment methods in Sarcoidosis are quite limited. Although relatively abundant in COPD, various studies conducted on Bronchiectasis, Pulmonary Arterial Hypertension and Asthma patients have shown that yoga results in a decrease in dyspnea and fatigue, and an increase in pulmonary functions and exercise capacity. On the other hand, no study has been found on yogic techniques in Sarcoidosis. Aim of this study is to investigate the effects of yogic techniques and conventional physiotherapy program on pulmonary functions, body oxygen level test (BOLT), exercise capacity (6MWT), anxiety, depression, fatigue, dyspnea perception, sleep quality and quality of life in sarcoidosis cases at different stages. In addition, holistic approaches gain importance due to the nature of the disease in these patients known to have multisystem involvement, and in this sense, this study is aimed to guide future rehabilitation studies.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Sarcoidosis by a physician (Stage II-III-IV)
* Pulmonary involvement
* Having fatigue symptoms (FAS ≥22 points)
* No immunosuppressive drug use for the last 1 year
* No antidepressant use for the last 6 months

Exclusion Criteria:

* Presence of cognitive impairment that prevents communication
* Anemia
* Uveitis
* Diabetes
* Pregnancy
* Major cardiovascular diseases
* Fractures
* Osteoporosis
* Those who have a neurological or orthopedic disease that will affect the treatment
* Those who are in the exacerbation period of the disease
* Tumor

Primary outcomes:
measure: Pulmonary Functions
timeFrame: Baseline and week 8
measure: Carbon Monoxide Diffusion Capacity of the Lungs (DLCO)
timeFrame: Baseline and week 8
measure: Body Oxygen Level Test (BOLT)
timeFrame: Baseline and week 8
measure: Fatigue Assessment
timeFrame: Baseline and week 8
measure: Exercise Capacity
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Respiratory muscle strength measurement
timeFrame: Baseline and week 8
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Baseline and week 8
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and week 8
measure: The Pittsburgh Sleep Quality Index
timeFrame: Baseline and week 8
measure: Quality of life measured by the St George's Respiratory Questionnaire
timeFrame: Baseline and week 8
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital
state: Maltepe
Study officials:
affiliation: University of Health science
name: Zuhal D TAKİNACI, PT, Asst Prof
role: STUDY_CHAIR
References:
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citation: Li C, Liu Y, Ji Y, Xie L, Hou Z. Efficacy of yoga training in chronic obstructive pulmonary disease patients: A systematic review and meta-analysis. Complement Ther Clin Pract. 2018 Feb;30:33-37. doi: 10.1016/j.ctcp.2017.11.006. Epub 2017 Nov 11.
citation: Fulambarker A, Farooki B, Kheir F, Copur AS, Srinivasan L, Schultz S. Effect of yoga in chronic obstructive pulmonary disease. Am J Ther. 2012 Mar;19(2):96-100. doi: 10.1097/MJT.0b013e3181f2ab86.
citation: Das RR, Sankar J, Kabra SK. Role of Breathing Exercises in Asthma-Yoga and Pranayama. Indian J Pediatr. 2022 Feb;89(2):174-180. doi: 10.1007/s12098-021-03998-w. Epub 2021 Nov 23.
citation: Baughman RP, Valeyre D, Korsten P, Mathioudakis AG, Wuyts WA, Wells A, Rottoli P, Nunes H, Lower EE, Judson MA, Israel-Biet D, Grutters JC, Drent M, Culver DA, Bonella F, Antoniou K, Martone F, Quadder B, Spitzer G, Nagavci B, Tonia T, Rigau D, Ouellette DR. ERS clinical practice guidelines on treatment of sarcoidosis. Eur Respir J. 2021 Dec 16;58(6):2004079. doi: 10.1183/13993003.04079-2020. Print 2021 Dec.