Pulmonary SarcoidosisphysioNCT04173689
The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis
A study testing Threshold IMT and breathing exercises combined with upper extremity and trunk in people with Pulmonary Sarcoidosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pulmonary Sarcoidosis
- What is being tested?
- Threshold IMT and breathing exercises combined with upper extremity and trunk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with stage I and IV,
- malignancy,
- heart failure,
- orthopedic problems
- who had to undergo systemic sarcoidosis treatment during the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- Threshold IMT, breathing exercises combined with upper extremity and trunk
- Keywords
- Sarcoidosis
- Medical subject headings
- Sarcoidosis, Pulmonary, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold IMTDevice
Also called Philips
7 days a week, 2 times a day 15 min each
breathing exercises combined with upper extremity and trunkOther
upper extremity and trunk exercises combined with breathing exercises for 7 days a week, 2 times a day for 15 minutes each
| Study group | Role | What they receive |
|---|---|---|
| Inspiratuar muscle training group | Active comparator | 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. Receives: Device: Threshold IMT |
| Exercise group | Active comparator | 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. Receives: Other: breathing exercises combined with upper extremity and trunk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity scale
0-7. high score shows deterioration. <2,8 no fatigue. >6,1 chronic fatigue syndrome
Measured: 8 week
6 minute walk test
Increased walking distance in 6 minutes
Measured: 8 week
Medical Research Council Dyspnea Scale
0-4. high score shows deterioration
Measured: 8 week
Respiratory assesment
measure respiratory muscle strength
Measured: 8 week
Epworth sleepiness scale
0-30. high score shows deterioration
Measured: 8 week
Hospital Anxiety Scale
anxiety 0-21 .high score shows deterioration
Measured: 8 week
Hospital Depression Scale
depression 0-21. high score shows deterioration
Measured: 8 week
Montreal Cognitive Assessment Scale
assess cognitive functions of individuals.0-30. high score indicates improvement
Measured: 8 week
London Chest Daily Living Activities Scale
Measuring daily living activities. high score shows deterioration. 0-75
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start15 Jan 2020
- Primary completion29 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary SarcoidosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Yildiz, Istanbul University - Cerrahpasa
- Investigators
- Rengin DEMİR, Study director, counselor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173689
- Sponsor's protocol ID
- Pulmonary Sarcoidosis
- Acronym
- physio
- Status last verified
- May 2022
- First submitted
- 7 Nov 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis
- ClinicalTrials.gov ID
- NCT04173689
- Acronym / sponsor ID
- physio / Pulmonary Sarcoidosis
- Conditions
- Pulmonary Sarcoidosis
- Keywords
- Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratuar muscle training group | Active comparator | Device: Threshold IMTThis 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. |
| Exercise group | Active comparator | Other: breathing exercises combined with upper extremity and trunkThis 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients with stage I and IV,
- malignancy,
- heart failure,
- orthopedic problems
- who had to undergo systemic sarcoidosis treatment during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threshold IMTAlso: Philips7 days a week, 2 times a day 15 min each | Device | Inspiratuar muscle training group |
| breathing exercises combined with upper extremity and trunkupper extremity and trunk exercises combined with breathing exercises for 7 days a week, 2 times a day for 15 minutes each | Other | Exercise group |
Primary outcome
Fatigue severity scale
Time frame: 8 week
0-7. high score shows deterioration. <2,8 no fatigue. >6,1 chronic fatigue syndrome
6 minute walk test
Time frame: 8 week
Increased walking distance in 6 minutes
Medical Research Council Dyspnea Scale
Time frame: 8 week
0-4. high score shows deterioration
Respiratory assesment
Time frame: 8 week
measure respiratory muscle strength
Epworth sleepiness scale
Time frame: 8 week
0-30. high score shows deterioration
Hospital Anxiety Scale
Time frame: 8 week
anxiety 0-21 .high score shows deterioration
Hospital Depression Scale
Time frame: 8 week
depression 0-21. high score shows deterioration
Montreal Cognitive Assessment Scale
Time frame: 8 week
assess cognitive functions of individuals.0-30. high score indicates improvement
London Chest Daily Living Activities Scale
Time frame: 8 week
Measuring daily living activities. high score shows deterioration. 0-75
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rengin DEMİR study director
counselor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold IMT and breathing exercises combined with upper extremity and trunk in people with Pulmonary Sarcoidosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity scale (time frame: 8 week). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.