Effects of Pulmonary Rehabilitation Exercises in Patients With Axial Spondyloarthritis

NCT07847879 | Active Not Recruiting

• 1 other identifier: AXSPA-PR-2025-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, single-blind controlled study evaluates the effects of pulmonary rehabilitation exercises in patients with axial spondyloarthritis. Participants were randomized into two groups. The intervention group received a pulmonary rehabilitation program in addition to conventional exercises, while the control group received conventional exercises alone. The primary outcome was pain intensity assessed using the Visual Analog Scale (VAS). Additional assessments included exercise capacity, pulmonary function, disease activity, quality of life, spinal mobility, and chest expansion. Outcomes were evaluated at baseline, week 8, and week 12.

Conditions

Axial Spondyloarthritis; Ankylosing Spondylitis (AS)

Keywords

Pulmonary Rehabilitation,; Respiratory Function; Quality of Life; Disease Activity

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Assessed by Visual Analog Scale (VAS)

  Pain intensity is assessed using a 0-10 cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Changes from baseline are evaluated at Week 8 and Week 12, with Week 12 defined as the primary endpoint.

  Baseline, Week 8, and Week 12

Secondary Outcomes (13)

• Change in 6-Minute Walk Distance (6MWD)

  Baseline, Week 8, and Week 12

• Change in Ankylosing Spondylitis Quality of Life (ASQoL) Score

  Baseline, Week 8, and Week 12

• Change in Maximum Voluntary Ventilation (MVV)

  Baseline, Week 8, and Week 12

• Change in Forced Vital Capacity (FVC)

  Baseline, Week 8, and Week 12

• Change in Forced Expiratory Volume in One Second (FEV1)

  Baseline, Week 8, and Week 12

Study Arms (2)

Pulmonary Rehabilitation Plus Conventional Exercise

EXPERIMENTAL

Participants received a structured pulmonary rehabilitation program in addition to conventional exercise for 8 weeks. The program included home-based breathing and range-of-motion exercises, supervised cycle ergometer exercise twice weekly, and upper-extremity and shoulder-girdle strengthening exercises.

Behavioral: Pulmonary Rehabilitation Program; Behavioral: Conventional Exercise Program

Conventional Exercise

ACTIVE COMPARATOR

Participants performed a home-based conventional exercise program. Exercise instructions were provided by video recording, and participants attended face-to-face follow-up sessions once weekly.

Behavioral: Conventional Exercise Program

Interventions

Conventional Exercise Program BEHAVIORAL

Participants performed a home-based conventional exercise program. Exercise instructions were provided through a video recording, and participants attended face-to-face follow-up sessions once weekly.

Conventional Exercise; Pulmonary Rehabilitation Plus Conventional Exercise

Pulmonary Rehabilitation Program BEHAVIORAL

The pulmonary rehabilitation program was administered for 8 weeks in addition to conventional exercise. Participants performed home-based breathing and range-of-motion exercises twice daily for 10 repetitions. Breathing exercises included pursed-lip breathing, diaphragmatic breathing, lateral abdominal breathing, relaxation and breathing control exercises, and neck and shoulder stretching. Participants also performed supervised cycle ergometer exercise twice weekly for 30 minutes per session, including warm-up and cool-down periods, together with upper-extremity and shoulder-girdle strengthening exercises.

Pulmonary Rehabilitation Plus Conventional Exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years.
• Fulfillment of the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for spondyloarthritis and/or diagnosis of ankylosing spondylitis according to the Modified New York criteria.
• Willingness to participate in the study and provision of informed consent.

You may not qualify if:

• Presence of a respiratory or cardiovascular disease that may affect exercise capacity, including chronic obstructive pulmonary disease, asthma, cardiac arrhythmia, or heart failure.
• Recent surgery that prevents participation in the exercise program.
• Upper-extremity musculoskeletal injury or history of thoracic trauma that may interfere with the exercise program.
• Chronic neuromuscular or musculoskeletal disease limiting upper-extremity function.
• Obesity, malignancy, or epilepsy.
• Pregnancy or breastfeeding.
• Severe contractures or axial deformities, including chest deformity, advanced kyphosis greater than 40 degrees, scoliosis, or rotoscoliosis.
• Neurological or psychiatric disorders, including ongoing depression, that may interfere with participation in the study.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Istanbul, 34396, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylitis, Ankylosing; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor was blinded to the participants' group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Resident

Model Details: Participants were randomized into two parallel groups: pulmonary rehabilitation plus conventional exercise or conventional exercise alone.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)