Clinical trial NCT06287983: Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity
Official title: Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity in Patients With Ankylosing Spondylitis Receiving Anti-TNF Therapy: Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankylosing Spondylitis
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A total of 44 patients were randomly divided 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. Inspiratory muscle training will also be added to the intervention group. Patients included in the study; At weeks 0, 6, 12 and 24, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index), ASQoL (The Ankylosing Spondylitis Quality of Life), Modified Borg Scale, Visual Analog scale (VAS) and maximum Dyspnea measurement during exercise, 6-minute walk test, chest expansion measurement and respiratory function test (spirometry) will be evaluated.
Primary purpose: TREATMENT

Brief summary: In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. We also aimed to investigate the relationship between these parameters and disease activity, spinal mobility and quality of life.

Detailed description: Patients diagnosed with AS who applied to outpatient clinic, received anti- tumor necrosis factor (TNF) treatment for at least 6 months and have been evaluated will be included in the study.

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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ankylosing spondylitis according to the Modified New York 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:

* The patient has a serious mental disorder
* 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

Primary outcomes:
measure: Respiratory function test (Spirometry)
timeFrame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI):
timeFrame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
measure: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
timeFrame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
measure: Modified Borg Scale
timeFrame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
measure: Measurement of dyspnea at maximum exercise with the Visual Analog Scale (VAS)
timeFrame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
measure: 6-minute walk test (6MWT)
timeFrame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
measure: Chest expansion measurement
timeFrame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Serap Tomruk Sütbeyaz, Prof
role: STUDY_DIRECTOR
affiliation: Saglik Bilimleri Universitesi
name: Esra Yaprak tas
role: PRINCIPAL_INVESTIGATOR
References: