Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity
NCT ID: NCT06287983
Last Updated: 2024-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
44 participants
INTERVENTIONAL
2023-06-01
2024-05-15
Brief Summary
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Detailed Description
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Patients who agree to participate in the study will be asked to sign a consent form. At the beginning, all patients' name-surname, age, height, body weight, body mass index, smoking-alcohol use, profession, marital status, education, duration of ankylosing spondylitis disease, history of corticosteroid use, presence of systemic and extra-articular involvement, medications used and additional diseases will be questioned and recorded in their files.
It was planned to include 30 male and 14 female patients in the study by calculating the female/male ratio of patients diagnosed with As who applied to hospital in the last year and in line with the literature. A total of 44 patients will be randomly randomized into 2 groups using the sealed envelope randomization method. The exercise program will be applied to both groups, 3 sessions a week for 60 minutes for 6 weeks.
The Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 3\*10 sets.
Inspiratory muscle training will also be added to the intervention group.
Inspiratory muscle training will be started at an intensity of 50% of the patient's measured PIMAX value and will be increased by 2 cm/H20 per day according to patient tolerance, and will be applied for a total of 6 weeks / 5 days per week / 3 sessions per day / 10 breaths per session.
Patients included in the study were evaluated with BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI(Bath Ankylosing Spondylitis Functional Index), ASQoL(The Ankylosing Spondylitis Quality of Life), Modified Borg Scale, measurement of dyspnea at maximum exercise with Visual Analog Scale (VAS), 6-minute walk test, chest expansion measurement and respiratory function test (spirometry) at 0, 6, 12 and 24 weeks will be evaluated.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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EXERCISE GROUP
The Sample Spondylitis Exercise Program
The Sample Spondylitis Exercise Program
The Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 3\*10 sets. The exercise program will be applied to both groups, 3 sessions a week for 60 minutes for 6 weeks.
EXERCISE+ Inspiratory muscle trainer (IMT) GROUP
The Sample Spondylitis Exercise Program Inspiratory muscle training will also be added to the intervention group.
Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic)
Inspiratory muscle training will be started at an intensity of 50% of the patient's measured PIMAX value and will be increased by 2 cm/H20 per day according to patient tolerance, and will be applied for a total of 6 weeks / 5 days per week / 3 sessions per day / 10 breaths per session.
The Sample Spondylitis Exercise Program
The Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 3\*10 sets. The exercise program will be applied to both groups, 3 sessions a week for 60 minutes for 6 weeks.
Interventions
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Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic)
Inspiratory muscle training will be started at an intensity of 50% of the patient's measured PIMAX value and will be increased by 2 cm/H20 per day according to patient tolerance, and will be applied for a total of 6 weeks / 5 days per week / 3 sessions per day / 10 breaths per session.
The Sample Spondylitis Exercise Program
The Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 3\*10 sets. The exercise program will be applied to both groups, 3 sessions a week for 60 minutes for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Patients with BASDAI score \<4.1 who received Anti-TNF therapy for at least 6 months
* Patients whose maximum inspiratory pressure value is \<80% in the Pulmonary Function Test
* Patients who had a cardiac examination within the last year and no cardiac pathology was detected.
Exclusion Criteria
* Presence of neurological and pulmonary disease that would prevent the patient from using the PFT device
* Presence of uncontrolled hypertension
* Presence of uncontrolled diabetes
* Presence of uncontrolled cardiac arrhythmia
* Uncontrolled heart failure
* High-risk unstable angina and all acute cardiac diseases (acute myocardial infarction, acute endocarditis, myocarditis or pericarditis)
* Symptomatic severe aortic stenosis
* Acute pulmonary embolism or pulmonary infarction
* Severe pulmonary hypertension
* Presence of systemic infection or malignancy
* Pregnancy
18 Years
65 Years
ALL
No
Sponsors
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Kayseri City Hospital
OTHER_GOV
Responsible Party
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Havva Talay Çalış
professor doctor
Principal Investigators
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Serap Tomruk Sütbeyaz, Prof
Role: STUDY_DIRECTOR
Saglik Bilimleri Universitesi
Esra Yaprak tas
Role: PRINCIPAL_INVESTIGATOR
Saglik Bilimleri Universitesi
Locations
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Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital
Kayseri, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KayseriCHIMT001
Identifier Type: -
Identifier Source: org_study_id
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