- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04173689
The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis (physio)
May 26, 2022 updated by: Esma Yildiz, Istanbul University - Cerrahpasa (IUC)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Istanbul
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Edirne, Istanbul, Turkey, 22000
- Esma Yıldız
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Inspiratuar muscle training group
This group will be given inspiratory muscle training (IMT) at home for 15 minutes twice a day for 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 (MRP) with the intraoral pressure measuring device, 30% of the measured MRP 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 MRP measurement every week.
|
7 days a week, 2 times a day 15 min each
Other Names:
|
ACTIVE_COMPARATOR: Exercise group
This group will perform upper extremity and trunk exercises combined with breathing exercises at home for 7 days, twice a day for 15 minutes.
Patients in both groups will perform a single 15-minute session once a week at the hospital under the supervision of a physiotherapist.
|
upper extremity and trunk exercises combined with breathing exercises for 7 days a week, 2 times a day for 15 minutes each
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue severity scale
Time Frame: 8 week
|
0-7. high score shows deterioration.
<2,8 no fatigue.
>6,1 chronic fatigue syndrome
|
8 week
|
6 minute walk test
Time Frame: 8 week
|
Increased walking distance in 6 minutes
|
8 week
|
Medical Research Council Dyspnea Scale
Time Frame: 8 week
|
0-4. high score shows deterioration
|
8 week
|
Respiratory assesment
Time Frame: 8 week
|
measure respiratory muscle strength
|
8 week
|
Epworth sleepiness scale
Time Frame: 8 week
|
0-30.
high score shows deterioration
|
8 week
|
Hospital Anxiety Scale
Time Frame: 8 week
|
anxiety 0-21 .high
score shows deterioration
|
8 week
|
Hospital Depression Scale
Time Frame: 8 week
|
depression 0-21.
high score shows deterioration
|
8 week
|
Montreal Cognitive Assessment Scale
Time Frame: 8 week
|
assess cognitive functions of individuals.0-30.
high score indicates improvement
|
8 week
|
London Chest Daily Living Activities Scale
Time Frame: 8 week
|
Measuring daily living activities.
high score shows deterioration.
0-75
|
8 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Rengin DEMİR, counselor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2020
Primary Completion (ACTUAL)
April 29, 2021
Study Completion (ACTUAL)
June 30, 2021
Study Registration Dates
First Submitted
November 7, 2019
First Submitted That Met QC Criteria
November 21, 2019
First Posted (ACTUAL)
November 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 31, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pulmonary Sarcoidosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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