The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis

Pulmonary Sarcoidosis Clinical Trial

— physio  

Official title:

The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173689
• Other study ID #: Pulmonary Sarcoidosis
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• The study was conducted in Istanbul University Cerrahpasa 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

Related Conditions & MeSH terms

• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Device:
• Threshold IMT
7 days a week, 2 times a day 15 min each

Other:
• breathing exercises combined with upper extremity and trunk
upper extremity and trunk exercises combined with breathing exercises for 7 days a week, 2 times a day for 15 minutes each

Locations

Country	Name	City	State
Turkey	Esma Yildiz	Edirne	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue severity scale	0-7. high score shows deterioration. <2,8 no fatigue. >6,1 chronic fatigue syndrome	8 week
Primary	6 minute walk test	Increased walking distance in 6 minutes	8 week
Primary	Medical Research Council Dyspnea Scale	0-4. high score shows deterioration	8 week
Primary	Respiratory assesment	measure respiratory muscle strength	8 week
Primary	Epworth sleepiness scale	0-30. high score shows deterioration	8 week
Primary	Hospital Anxiety Scale	anxiety 0-21 .high score shows deterioration	8 week
Primary	Hospital Depression Scale	depression 0-21. high score shows deterioration	8 week
Primary	Montreal Cognitive Assessment Scale	assess cognitive functions of individuals.0-30. high score indicates improvement	8 week
Primary	London Chest Daily Living Activities Scale	Measuring daily living activities. high score shows deterioration. 0-75	8 week