Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity

NCT06287983 | Recruiting

• 1 other identifier: KayseriCHIMT001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI):

  before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)

• 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)

• 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)

Study Arms (2)

EXERCISE GROUP

EXPERIMENTAL

The Sample Spondylitis Exercise Program

Other: The Sample Spondylitis Exercise Program

EXERCISE+ Inspiratory muscle trainer (IMT) GROUP

ACTIVE COMPARATOR

The Sample Spondylitis Exercise Program Inspiratory muscle training will also be added to the intervention group.

Device: Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic); Other: The Sample Spondylitis Exercise Program

Interventions

Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic) DEVICE

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.

EXERCISE+ Inspiratory muscle trainer (IMT) GROUP

The Sample Spondylitis Exercise Program OTHER

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 GROUP; EXERCISE+ Inspiratory muscle trainer (IMT) GROUP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Serap Tomruk Sütbeyaz, Prof

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

• Esra Yaprak tas

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Havva Talay Calıs, Prof

CONTACT

+90532 687 45 41; htalaycalis@yahoo.com

Esra Yaprak tas, MD

CONTACT

+905062007571; yaprak8100@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor doctor

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 1, 2024
• Study Start: June 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 15, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

TU (1)