Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity

Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity in Patients With Ankylosing Spondylitis Receiving Anti-TNF Therapy: Randomized Controlled Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Other: The Sample Spondylitis Exercise Program; Device: Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic)

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Havva Talay Çalış, Prof; Phone Number: +90532 687 45 41; Email: htalaycalis@yahoo.com
• Study Contact Backup: Name: Esra Yaprak Tas, MD; Phone Number: +905062007571; Email: yaprak8100@gmail.com

Study Locations

• Turkey
  • Kayseri, Turkey, 38080
    • Recruiting
    • Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital
    • Contact: Esra Yaprak Tas, MD; Phone Number: +905062007571; Email: yaprak8100@gmail.com
    • Contact: Havva Talay Çalış, Prof; Phone Number: 61244 +90352 315 77 00; Email: htalaycalis@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXERCISE GROUP; The Sample Spondylitis Exercise Program	Other: 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.
Active Comparator: EXERCISE+ Inspiratory muscle trainer (IMT) GROUP; The Sample Spondylitis Exercise Program Inspiratory muscle training will also be added to the intervention group.	Other: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory function test (Spirometry)	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.	before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI):	It evaluates disease-specific symptoms such as fatigue, spinal and peripheral joint pain, swelling and morning stiffness and is interpreted on a score ranging from 0-10. An increase in the score indicates an increase in disease activity. It is a reliable and sensitive index developed to evaluate disease activity and progression.	before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Bath Ankylosing Spondylitis Functional Index (BASFI)	It is a fast and easy-to-apply, sensitive and reliable index developed to determine and monitor the functional status of patients with AS. It consists of 10 questions that evaluate patients' abilities to bend, reach, stand, change positions, climb stairs, and cope with activities of daily living. For each question, the final score is obtained by dividing the total score by 10 using VAS in the range of 0-10 cm.	before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)	ASQoL is the most widely used, valid and reliable questionnaire to evaluate the quality of life in AS. In this survey, which consists of eighteen questions, patients are asked to answer yes or no to each question. '0' points are taken for a no answer and '1' point is taken for a yes answer. Total score varies between 0-18. High scores indicate serious impairments in quality of life.	before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Modified Borg Scale	It is a scale frequently used to evaluate the severity of exertion dyspnea and resting dyspnea severity. It consists of ten items that describe the severity of dyspnea according to its degree. Defining the severity of dyspnea in the Modified Borg Scale makes it easier for patients to apply.	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)	Visual Analog Scale (VAS) is a scale applied by marking with a pencil on a horizontal or vertical line of one hundred millimeters. There is no dyspnea at the 0 mm point of this line, and the most severe dyspnea is at the 100 mm point. The patient marks the severity of the current respiratory distress on the scale using these two degrees as criteria. Scoring is done by measuring the marked point with the help of a tape measure. Most of the studies conducted to date indicate that VAS is a reliable scale that can be used to evaluate the severity of dyspnea, and that it is even sensitive to minute changes in the severity of dyspnea.	before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
6-minute walk test (6MWT)	It is a frequently used test in cardiopulmonary rehabilitation to monitor exercise capacity and treatment effectiveness. The patient should rest by sitting in a chair for 15 minutes before the test and wear appropriate shoes and comfortable clothing. Calculate the distance walked by the patient at their own walking pace in 6 minutes, preferably in a 30-meter long corridor. If the patient's O2 saturation (sO2) is <88%, the test should be performed with O2 support.	before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Chest expansion measurement	Chest expansion is measured at the fourth intercostal space. The patient is asked to exhale all the air in his lungs and then take deep inspiration. As a result of deep inspiration, the expansion around the chest is recorded in centimeters.	before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)

Collaborators and Investigators

• Sponsor: Kayseri City Hospital
• Investigators: Study Director: Serap Tomruk Sütbeyaz, Prof, Saglik Bilimleri Universitesi; Principal Investigator: Esra Yaprak tas, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): May 15, 2024

Study Registration Dates

• First Submitted: February 24, 2024
• First Submitted That Met QC Criteria: February 24, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: KayseriCHIMT001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No