Comparison of the Effects of Yoga and Conventional Physiotherapy Programs in Sarcoidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSaglik Bilimleri Universitesi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Presence of cognitive impairment that prevents communication
Anemia
Uveitis
Diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
traditional physiotherapy group
Procedure/Surgery* 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 program
Procedure/SurgeryPranayamic 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)
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Conventional Physiotherapy GroupActive comparator 1 intervention
Group B: Yoga GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and week 82
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.
Time frame
Baseline and week 83
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.
Time frame
Baseline and week 84
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
Time frame
Baseline and week 8Secondary outcomes
1
Respiratory muscle strength measurement
The patient is seated in a straight-backed chair. After the patient is asked to make a deep exhalation, he is expected to take a deep inspiration for 1-3 seconds. Measurements are repeated 3 times and the highest value is taken.
Time frame
Baseline and week 82
Modified Medical Research Council (mMRC) Dyspnea Scale
mMRC is a 0-4 point category scale where patients select the value that best describes their level of dyspnea
Time frame
Baseline and week 83
Hospital Anxiety and Depression Scale (HADS)
It includes anxiety and depression subscales. The scale is a self-report scale and consists of a total of 14 items, 7 of which investigate depression and 7 anxiety symptoms. Responses are evaluated in a four-point Likert format and scored between 0-3.
Time frame
Baseline and week 84
The Pittsburgh Sleep Quality Index
PSQI consists of 24 questions in total. 19 of these questions are self-evaluation questions. The remaining 5 questions are answered by the individual's roommate or spouse, if any. The first 18 questions answered by the participant are used in calculating the PSQI total score and component scores. The 18 questions answered by the participant provide information on 7 components: sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6), and daytime sleep dysfunction (component 7). Each component is evaluated on a scale of 0-3 points. The sum of these 7 component scores gives the total PSQI score. Total PSQI score varies between 0-21. While the sleep quality of individuals with a total score of 5 or less is considered "good", the sleep quality of individuals with a score above 5 is considered "bad".
Time frame
Baseline and week 8Sponsors and contacts
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Saglik Bilimleri Universitesi
Lead sponsor
Istanbul Saglik Bilimleri University
Collaborator
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
Collaborator
Source ClinicalTrials.gov