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

NCT06848608 | Recruiting

• 1 other identifier: SYT-2025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis; Pulmonary Rehabilitation; Yoga

Keywords

pulmonary rehabilitation; sarcoidosis; yoga

Outcome Measures

Primary Outcomes (5)

• Pulmonary Functions

  Spirometric measurement; It will be performed according to ATS/ERS criteria using a spirometer. Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, 25-75% of forced expiratory flow (FEF25-75, forced mid-expiratory flow) and peak expiratory flow (PEF) values can be measured with a spirometer.

  Baseline and week 8

• Carbon Monoxide Diffusion Capacity of the Lungs (DLCO)

  It measures gas exchange in the lungs. This test evaluates alveolar surface area, membrane integrity and pulmonary capillary blood flow.

  Baseline and week 8

• Body Oxygen Level Test (BOLT)

  The BOLT result depends on the concentration of carbon dioxide the body can tolerate and the respiratory response to carbon dioxide, and is calculated by breath hold time. It has been stated that BOLT is significantly associated with distance in 6MWT. This provides clinical benefit as it is a cost-free and rapid test as a respiratory function parameter.

  Baseline and week 8

• Fatigue Assessment

  It is aimed to evaluate fatigue status with the Fatigue Assessment Questionnaire (FAS), which was developed by Michielsen et al. in 2003, is one-dimensional and consists of ten questions and measures physical and psychological fatigue. The total score varies between 10-50. If the FAS score is between 22-34; If you are tired and FAS score is ≥35; is considered overly tired

  Baseline and week 8

• Exercise Capacity

  A 6-minute walk test is performed for exercise capacity. After resting in a chair for a sufficient period (\>30 minutes), patients walk as fast as possible, without running, for 6 minutes on a straight 30-meter corridor. Before and after the test, the patient's fatigue and dyspnea are questioned using the Modified Borg Scale. Oxygen saturation and heart rate are monitored and recorded using a finger pulse oximeter before, during, and after the test.

  Baseline and week 8

Secondary Outcomes (5)

• Respiratory muscle strength measurement

  Baseline and week 8

• Modified Medical Research Council (mMRC) Dyspnea Scale

  Baseline and week 8

• Hospital Anxiety and Depression Scale (HADS)

  Baseline and week 8

• The Pittsburgh Sleep Quality Index

  Baseline and week 8

• Quality of life measured by the St George's Respiratory Questionnaire

  Baseline and week 8

Study Arms (2)

Conventional Physiotherapy Group

ACTIVE COMPARATOR

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.

Procedure: traditional physiotherapy group

Yoga Group

ACTIVE COMPARATOR

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.

Procedure: yoga program

Interventions

traditional physiotherapy group 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)

Conventional Physiotherapy Group

yoga program 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)

Yoga Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Istanbul Saglik Bilimleri University: collaborator
• Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital: collaborator

Study Sites (1)

Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital

Istanbul, Maltepe, 34844, Turkey (Türkiye)

RECRUITING

Related Publications (6)

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

  PMID: 24963220 BACKGROUND

• 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.

  PMID: 23851328 BACKGROUND

• 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.

  PMID: 29389476 BACKGROUND

• 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.

  PMID: 21048431 BACKGROUND

• 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.

  PMID: 34812995 BACKGROUND

• 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.

  PMID: 34140301 BACKGROUND

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Zuhal D TAKİNACI, PT, Asst Prof

  University of Health science

  STUDY CHAIR

Central Study Contacts

Şeyda YILDIZ, PhD(c), PT

CONTACT

+905378484687; yildizseydaa@gmail.com

Zuhal D TAKİNACI, Asst Prof, PT

CONTACT

+905368636153; didem.takinaci@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 27, 2025
• Study Start: November 30, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 30, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)