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NCT Number: NCT07430189

Multimodal Pulmonary Rehabilitation in Radiographic Axial Spondyloarthritis

This prospective pilot study aims to evaluate the efficacy of a structured 8-week multimodal pulmonary rehabilitation (PR) program specifically designed for patients with radiographic axial spondyloarthritis (r-axSpA). The study assesses the impact of a composite intervention incorporating aerobic conditioning, resistance training, flexibility protocols, and targeted diaphragmatic breathing on functional exercise capacity, dyspnea severity, and pulmonary function.

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Key information

Conditions

Axial Spondyloarthritis (AxSpA) Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Dyspnea Joint Diseases Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balikesir University Faculty of Medicine

Balıkesir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 75 years.
  • Diagnosis of radiographic axial spondyloarthritis (r-axSpA) confirmed according to the Modified New York Criteria.
  • Clinical stability without acute flares or escalation of systemic therapy in the preceding 3 months.
  • Ability to perform spirometry and ambulate safely.

Exclusion criteria

  • Primary respiratory disorders (e.g., COPD and interstitial lung disease) acting as the primary cause of limitation.
  • Significant cardiovascular contraindications to exercise.
  • Pregnancy.
  • Participation in a structured rehabilitation program within the last 3 months.

Treatment and study plan

Multimodal pulmonary rehabilitation

Behavioral

An 8-week structured exercise program consisting of three sessions per week (two supervised hospital-based sessions and one structured home-based session). The intervention integrates aerobic conditioning using a treadmill and arm ergometer, resistance and mobility training targeting spinal extension, and specific respiratory muscle training including diaphragmatic and pursed-lip breathing maneuvers.

Primary outcomes

  1. Change in 6-Minute Walk Distance (6MWD)

    Time frame: Baseline and Week 8

    Functional exercise capacity is measured by the total distance walked in 6 minutes, recorded in meters. Higher values indicate better functional exercise capacity (better outcome).

Secondary outcomes

  1. Change in Forced Vital Capacity (FVC)

    Time frame: Baseline and Week 8

    Forced Vital Capacity (FVC) is measured via spirometry and expressed as a percentage of the predicted value. Higher percentages indicate better pulmonary volume and respiratory function (better outcome).

  2. Change in Borg Dyspnea Scale

    Time frame: Baseline and Week 8

    The Modified Borg Dyspnea Scale is used to assess exertional breathlessness. The scale ranges from a minimum of 0 (no dyspnea at all) to a maximum of 10 (maximal dyspnea). Higher scores indicate more severe breathlessness (worse outcome).

  3. Change in BASFI Score

    Time frame: Baseline and Week 8

    The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses the degree of functional limitation in daily activities. The scale ranges from a minimum of 0 to a maximum of 10. Higher scores indicate greater functional impairment and disability (worse outcome).

  4. Change in SF-36 Mental Health Score

    Time frame: Baseline and Week 8

    The 36-Item Short Form Health Survey (SF-36) is a health-related quality of life questionnaire. The Mental Health domain is scored from a minimum of 0 to a maximum of 100. Higher scores indicate a more favorable mental health state and better well-being (better outcome).

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Official study title

Multimodal Pulmonary Rehabilitation in Radiographic Axial Spondyloarthritis: A Prospective Pilot Study Addressing Mechanical Restriction and Functional Capacity

Acronym: PuRe-axSpA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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