Clinical trial NCT04173689: The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis
Official title: The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Sarcoidosis
Keywords: Sarcoidosis
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is an educational work. Thirty patients with pulmonary sarcoidosis will be included in the study and randomly selected into two training groups.One group will receive home inspiratory muscle training (IMT) for 15 minutes, twice a day, 7 days a week with the resh Threshold IMT 'device. In the IMT group, the initial training intensity will be determined by measuring the maximal inspiratory muscle strength (MIP) with the intraoral pressure measuring device, 30% of the measured (MIP) value will be started at the first evaluation and the new training intensity will be determined by calculating 30% of the measured value by repeating the MIP measurement every week. The other group will perform upper extremity and trunk exercises combined with respiratory exercises at home for 7 days, twice a day for 15 minutes.Patients will be evaluated before the training program and 8 weeks after the training. In the first evaluation, demographic information and clinical characteristics of the patients will be noted.In this study, upper and lower extremity exercise capacity, respiratory functions, peripheral muscle strength, dyspnea, fatigue, sleep quality, cognitive function, daily living activities, physical activity level, anxiety, depression, upper extremity and trunk exercises combined with inspiratory muscle training in patients with sarcoidosis and the impact on quality of life.

Detailed description: Patients who are in stage II-III with sarcoidosis diagnosed pulmonary involvement who are admitted to the Department of Chest Diseases of Cerrahpaşa Medical Faculty Hospital of Istanbul University will be included in the 30-70 age group 6 months after systemic treatment or no treatment. Patients with stages I and IV, malignancy, heart failure, orthopedic problems and who have to undergo systemic sarcoidosis treatment during the study will not be included in the study. Thirty-four patients who meet the inclusion criteria will be included in the study by signing the informed consent form. In the first evaluation, demographic information and clinical characteristics of the patients will be noted. Lower and upper extremity functional capacities of the patients before and after training will be evaluated with 6-minute walk test (6MWT), 6-minute step test (6DST), 6-minute pegboard ring test (6DPBRT) and 30-second sit-down test. Percentage values of FVC, FEV1, FEV1 / FVC, PEF, FEF (25-75%) parameters according to measured and expected values will be recorded by performing pulmonary function test. Respiratory muscle strength will be determined by measuring maximal inspiratory pressure (MRP) and maximal expiratory pressure (MEP) with the intraoral pressure gauge. Dyspnea sensation Modified Borg and Modified Medical Research Council (MMRC) scale, fatigue state Fatigue Severity Scale (FSS), peripheral muscle strength hand dynamometer, quality of life George Respiratory Diseases Questionnaire (SGRQ), anxiety and depression status Hospital Anxiety and Depression Scale (HAD), physical activity level International Physical Activity Questionnaire-Short form (IPAQ-S), cognitive function Montreal Cognitive Assessment Scale (MOCA), daily living activities London Chest Daily Living Activities Scale and sleep quality will be evaluated with Epworth Sleepiness Scale (ESS).

Eligibility criteria: Inclusion Criteria:

* The study was conducted in Istanbul University Cerrahpaşa Medical Faculty Hospital Pulmonary Diseases Department with sarcoidosis diagnosed with pulmonary involvement in stage II-III,
* 6 months after receiving systemic treatment or no treatment.

Exclusion Criteria:

* Patients with stage I and IV,
* malignancy,
* heart failure,
* orthopedic problems
* who had to undergo systemic sarcoidosis treatment during the study

Primary outcomes:
measure: Fatigue severity scale
timeFrame: 8 week
measure: 6 minute walk test
timeFrame: 8 week
measure: Medical Research Council Dyspnea Scale
timeFrame: 8 week
measure: Respiratory assesment
timeFrame: 8 week
measure: Epworth sleepiness scale
timeFrame: 8 week
measure: Hospital Anxiety Scale
timeFrame: 8 week
measure: Hospital Depression Scale
timeFrame: 8 week
measure: Montreal Cognitive Assessment Scale
timeFrame: 8 week
measure: London Chest Daily Living Activities Scale
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Esma Yıldız
state: Istanbul
Study officials:
affiliation: counselor
name: Rengin DEMİR
role: STUDY_DIRECTOR
References: