Comparison of the Effects of Yoga and Conventional Physiotherapy Programs in Sarcoidosis

NCT ID: NCT06848608

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2025-05-30

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.

Conditions

Sarcoidosis; Pulmonary Rehabilitation; Yoga

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Physiotherapy Group

The exercises will be taught to the patients one-on-one by the physiotherapist in the hospital. The exercises will be performed 2 days a week for 8 weeks with a group-based, supervised and standardized tele-rehabilitation program and the remaining 3 days of the week with an exercise diary where they will take notes on their continued exercise.

Program content;

• Resistance training: Strengthening exercises will be given to the upper and lower extremities
• Respiratory Training:

Pursed-lip breathing training Chest breathing exercise Diaphragmatic breathing exercise

• Thoracic expansion exercises

In addition, patients in this group will be given free walking 3 days a week in terms of aerobic training.

Group Type: ACTIVE_COMPARATOR

traditional physiotherapy group

Intervention Type: PROCEDURE

• Resistance training: It is planned to give strengthening exercises for the upper and lower extremities (quadriceps, hamstrings, gluteus medius, gastrosoleus, deltoids, triceps and biceps brachii) with the resistive exercise band. The fatigue severity perceived by the patients during the exercises is aimed to be 4-6 according to the Modified Borg scale
• Pursed-lip breathing training (10 repetitions)
• Chest breathing exercise (10 repetitions)
• Diaphragmatic breathing exercise (10 repetitions)
• Thoracic expansion exercises (10 repetitions - apical expansion, unilateral basal expansion, bilateral basal expansion, posterior basal expansion)

Additionally In terms of aerobic training, free walking will be provided 3 days a week. (Based on distance determined by 6 DYT)

Yoga Group

The pranayama techniques and asanas in this group will be taught one-on-one by the physiotherapist in the hospital. For 8 weeks, 2 days of the week will be a group-based, supervised and standardized telerehabilitation program, and the remaining 3 days of the week will be followed by an exercise diary in which they will take notes on the continuation of the exercises.

Content of the program; Pranayamic techniques Asanas

In addition, patients in this group will be given free walking 3 days a week in terms of aerobic training.

Group Type: ACTIVE_COMPARATOR

yoga program

Intervention Type: PROCEDURE

Pranayamic techniques:

Nadi Shodhana: 2 sets of nadi shodhana pranayama consisting of 8 breathing cycles will be applied.

Ujjai: Two sets of ujjayi technique consisting of 10 breathing cycles with an inhalation:exhalation ratio of 1:2 in each session will be applied with a 1-minute rest period between sets.

Bhramari: Two sets of bhramari pranayama consisting of 10 breathing cycles will be applied with a low respiratory rate with a 1-minute rest period between sets.

Sukha Pranayama : It will be applied 5:5 inhalation:exhalation ratio for 5 minutes.

Kapalabhati: 15 quick breaths in 10 seconds followed by a 20-second break (30 breaths per minute in total) will be practiced for 3 minutes

Asanas:

Sukhasana Bharadvajasana Marjaryasana- Bitilasana Bhujaganasana Kapotasana Hasta uttanasana Virabhadrasana I

In addition, free walking will be given 3 days a week in terms of aerobic training. (Based on distance determined by 6 DYT)

Interventions

traditional physiotherapy group

• Resistance training: It is planned to give strengthening exercises for the upper and lower extremities (quadriceps, hamstrings, gluteus medius, gastrosoleus, deltoids, triceps and biceps brachii) with the resistive exercise band. The fatigue severity perceived by the patients during the exercises is aimed to be 4-6 according to the Modified Borg scale
• Pursed-lip breathing training (10 repetitions)
• Chest breathing exercise (10 repetitions)
• Diaphragmatic breathing exercise (10 repetitions)
• Thoracic expansion exercises (10 repetitions - apical expansion, unilateral basal expansion, bilateral basal expansion, posterior basal expansion)

Additionally In terms of aerobic training, free walking will be provided 3 days a week. (Based on distance determined by 6 DYT)

Intervention Type: PROCEDURE

yoga program

Pranayamic techniques:

Nadi Shodhana: 2 sets of nadi shodhana pranayama consisting of 8 breathing cycles will be applied.

Ujjai: Two sets of ujjayi technique consisting of 10 breathing cycles with an inhalation:exhalation ratio of 1:2 in each session will be applied with a 1-minute rest period between sets.

Bhramari: Two sets of bhramari pranayama consisting of 10 breathing cycles will be applied with a low respiratory rate with a 1-minute rest period between sets.

Sukha Pranayama : It will be applied 5:5 inhalation:exhalation ratio for 5 minutes.

Kapalabhati: 15 quick breaths in 10 seconds followed by a 20-second break (30 breaths per minute in total) will be practiced for 3 minutes

Asanas:

Sukhasana Bharadvajasana Marjaryasana- Bitilasana Bhujaganasana Kapotasana Hasta uttanasana Virabhadrasana I

In addition, free walking will be given 3 days a week in terms of aerobic training. (Based on distance determined by 6 DYT)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role: collaborator

Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role: collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Şeyda YILDIZ

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zuhal D TAKİNACI, PT, Asst Prof

Role: STUDY_CHAIR

University of Health science

Locations

Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital

Istanbul, Maltepe, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Şeyda YILDIZ, PhD(c), PT

Role: CONTACT

yildizseydaa@gmail.com

+905378484687

Zuhal D TAKİNACI, Asst Prof, PT

Role: CONTACT

didem.takinaci@sbu.edu.tr

+905368636153

Facility Contacts

Zuhal D TAKİNACI, Asst Prof, PT

Role: primary

didemtakinaci@gmail.com

+905368636153

Şeyda YILDIZ, PhD(c), PT

Role: backup

yildizseydaa@gmail.com

+905378484687

References

Taneja DK. Yoga and health. Indian J Community Med. 2014 Apr;39(2):68-72. doi: 10.4103/0970-0218.132716.

Reference Type: BACKGROUND

PMID: 24963220 (View on PubMed)

Marcellis RG, Lenssen AF, de Vries J, Drent M. Reduced muscle strength, exercise intolerance and disabling symptoms in sarcoidosis. Curr Opin Pulm Med. 2013 Sep;19(5):524-30. doi: 10.1097/MCP.0b013e328363f563.

Reference Type: BACKGROUND

PMID: 23851328 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29389476 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21048431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34812995 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34140301 (View on PubMed)

Other Identifiers

SYT-2025

Identifier Type: -

Identifier Source: org_study_id