Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04173689
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2019-11-07
Brief Title:
The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
physio
Brief Summary:
This is an educational work Thirty patients with pulmonary sarcoidosis will be included in the study and randomly selected into two training groupsOne 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 minutesPatients 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 notedIn 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None