Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity in Patients With Ankylosing Spondylitis Receiving Anti-TNF Therapy: Randomized Controlled Study.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Respiratory function test (Spirometry)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
EXERCISE GROUP
The Sample Spondylitis Exercise Program
Intervention: The Sample Spondylitis Exercise Program (Other)
EXERCISE+ Inspiratory muscle trainer (IMT) GROUP
The Sample Spondylitis Exercise Program Inspiratory muscle training will also be added to the intervention group.
Intervention: Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic) (Device)
EXERCISE+ Inspiratory muscle trainer (IMT) GROUP
The Sample Spondylitis Exercise Program Inspiratory muscle training will also be added to the intervention group.
Intervention: The Sample Spondylitis Exercise Program (Other)
Outcomes
Primary Outcomes
Respiratory function test (Spirometry)
Time Frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Spirometry is the most commonly used respiratory function test (PFT). It is a physiological test based on measuring the flow or volume changes that occur during breathing as a derivative of time. The standard maneuver used during spirometry is also called the forced expiratory maneuver; It consists of rapid and deep inspiration followed by maximal expiration at the level of total lung volume. The spirometry test to be evaluated must comply with the previously defined spirometry test performance standards, acceptability and repeatability criteria. In the study, the most frequently measured spirometric parameters with forced expiration maneuver were; vital capacity (VC), forced vital capacity (FVC), forced expiratory volume (FEV), maximum inspiratory pressure (PImax) and maximum expiratory pressure (Pemax) to evaluate respiratory muscle strength will be checked.
Secondary Outcomes
- Bath Ankylosing Spondylitis Functional Index (BASFI)(before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24))
- Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)(before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24))
- Modified Borg Scale(before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24))
- 6-minute walk test (6MWT)(before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24))
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI):(before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24))
- Measurement of dyspnea at maximum exercise with the Visual Analog Scale (VAS)(before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24))
- Chest expansion measurement(before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24))
Investigators
Havva Talay Çalış
professor doctor
Kayseri City Hospital