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NCT07914439
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Inspiratory Muscle Training in Axial Spondyloarthritis

Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital

View on ClinicalTrials.gov

Summary

This study investigated the effects of inspiratory muscle training (IMT) combined with aerobic exercise on diaphragm function, disease activity, functional exercise capacity, fatigue, sleep quality, and health-related quality of life in patients with axial spondyloarthritis (AxSpA). Axial spondyloarthritis is a chronic inflammatory rheumatic disease that primarily affects the spine and sacroiliac joints. Reduced chest wall mobility and respiratory muscle function may contribute to decreased exercise capacity, fatigue, and impaired quality of life. This randomized controlled trial was conducted at Bursa Yuksek Ihtisas Training and Research Hospital, Türkiye, between May 2023 and March 2024. Forty-two male patients aged 18-60 years were randomly allocated to two groups. The control group received aerobic exercise and conventional spinal mobility exercises, while the intervention group received additional inspiratory muscle training using a respiratory resistance device. Both groups participated in a 12-week exercise program. Participants were assessed at baseline and after 12 weeks using diaphragm ultrasonography, disease activity measures, functional exercise tests, and validated questionnaires assessing fatigue, sleep quality, and quality of life. The study aimed to determine whether adding inspiratory muscle training to an aerobic exercise program provides additional clinical benefits for patients with axial spondyloarthritis.

Official title: Impact of Inspiratory Muscle Training Plus Aerobic Exercise on Diaphragm Function, Disease Activity, and Sleep Quality in Axial Spondyloarthritis: A Pilot Randomized Controlled Trial

Key Details

Gender

MALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2023-05-31

Completion Date

2024-03-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Aerobic Exercise

Supervised treadmill walking at 55-80% of maximum heart rate, three sessions per week for 12 weeks. Each session consisted of 40 minutes of aerobic exercise, preceded by 5-10 minutes of warm-up and followed by 5-10 minutes of cool-down.

BEHAVIORAL

Conventional Spinal Mobility Exercises

Home-based flexibility, range-of-motion, abdominal, and breathing exercises performed as 3 sets of 10 repetitions, five days per week, for 12 weeks.

BEHAVIORAL

Inspiratory Muscle Training

Inspiratory muscle training was performed using a Powerbreathe Classic HR inspiratory resistance device. Participants performed 30 breaths twice daily, five days per week, for 12 weeks. Training started at a resistance of 10 cmH₂O and was progressively increased according to the study protocol. Resistance adjustments were reviewed weekly by a physiatrist.

Locations (1)

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, Bursa, Turkey (Türkiye)