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Completed

NCT Number: NCT04173689

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

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.

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Key information

Conditions

Pulmonary Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Respiratory Tract Diseases Sarcoidosis Sarcoidosis, Pulmonary

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esma Yıldız

Edirne, Istanbul, 22000, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Threshold IMT

Device

7 days a week, 2 times a day 15 min each

Other names: Philips

breathing exercises combined with upper extremity and trunk

Other

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

Primary outcomes

  1. Fatigue severity scale

    Time frame: 8 week

    0-7. high score shows deterioration. <2,8 no fatigue. >6,1 chronic fatigue syndrome

  2. 6 minute walk test

    Time frame: 8 week

    Increased walking distance in 6 minutes

  3. Medical Research Council Dyspnea Scale

    Time frame: 8 week

    0-4. high score shows deterioration

  4. Respiratory assesment

    Time frame: 8 week

    measure respiratory muscle strength

  5. Epworth sleepiness scale

    Time frame: 8 week

    0-30. high score shows deterioration

  6. Hospital Anxiety Scale

    Time frame: 8 week

    anxiety 0-21 .high score shows deterioration

  7. Hospital Depression Scale

    Time frame: 8 week

    depression 0-21. high score shows deterioration

  8. Montreal Cognitive Assessment Scale

    Time frame: 8 week

    assess cognitive functions of individuals.0-30. high score indicates improvement

  9. London Chest Daily Living Activities Scale

    Time frame: 8 week

    Measuring daily living activities. high score shows deterioration. 0-75

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Acronym: physio

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2019
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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