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临床试验/NCT07847879
NCT07847879进行中(未招募)不适用

Effects of Pulmonary Rehabilitation Exercises on Pain, Respiratory Muscles, Quality of Life, and Disease Activity in Patients With Axial Spondyloarthritis: A Prospective Randomized Single-Blind Controlled Study

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家实际入组 48 人开始时间: 2025年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
48
试验地点
1
主要终点
Change in Pain Intensity Assessed by Visual Analog Scale (VAS)

研究概览

简要总结

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.

详细描述

This is a single-center, prospective, randomized, single-blind controlled study conducted in patients with axial spondyloarthritis followed at the Physical Medicine and Rehabilitation Clinic of Sisli Hamidiye Etfal Training and Research Hospital.

Participants were randomized into two groups using the National Cancer Institute Clinical Trial Randomization Tool with the Maximally Tolerated Imbalance method. The intervention group received conventional exercises together with a structured pulmonary rehabilitation program. The pulmonary rehabilitation program included breathing exercises, range-of-motion exercises, aerobic exercise, and strengthening exercises.

Participants in the intervention group performed home-based range-of-motion and breathing 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 exercises. In addition, participants completed supervised cycle ergometer exercise sessions at the hospital twice weekly for 8 weeks, with each session lasting approximately 30 minutes including warm-up and cool-down periods. Aerobic exercise intensity was prescribed at moderate intensity using the Karvonen method, with the Borg Rating of Perceived Exertion used when appropriate. Upper-extremity and shoulder-girdle strengthening exercises were also included.

The control group received a conventional exercise program.

The primary outcome was pain intensity measured using the Visual Analog Scale (VAS), with the primary endpoint defined as week 12. Secondary assessments included the Six-Minute Walk Test, Ankylosing Spondylitis Quality of Life Questionnaire, Maximal Voluntary Ventilation, pulmonary function tests, chest expansion, modified Schober distance, occiput-to-wall distance, lateral spinal flexion, Bath Ankylosing Spondylitis Disease Activity Index, and C-reactive protein. Assessments were performed at baseline, week 8, and week 12.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
治疗
盲法
单盲 (结局评估者)

盲法说明

The outcome assessor was blinded to the participants' group allocation.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Pulmonary Rehabilitation Program (Behavioral)

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.

干预措施: Conventional Exercise Program (Behavioral)

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.

干预措施: Conventional Exercise Program (Behavioral)

结局指标

主要结局

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

时间窗: Baseline, Week 8, and Week 12

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.

次要结局

  • 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)
  • Change in FEV1/FVC Ratio(Baseline, Week 8, and Week 12)
  • Change in Peak Expiratory Flow (PEF)(Baseline, Week 8, and Week 12)
  • Change in Chest Expansion(Baseline, Week 8, and Week 12)
  • Change in Modified Schober Test(Baseline, Week 8, and Week 12)
  • Change in Occiput-to-Wall Distance(Baseline, Week 8, and Week 12)
  • Change in Lateral Spinal Flexion(Baseline, Week 8, and Week 12)
  • Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score(Baseline, Week 8, and Week 12)
  • Change in C-Reactive Protein (CRP) Level(Baseline, Week 8, and Week 12)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
其他
责任方
主要研究者
主要研究者

Latif Tosun

Physical Medicine and Rehabilitation Resident

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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标识符

NCT 编号
NCT07847879
其他研究编号
AXSPA-PR-2025-01

日期

首次提交
(8天前)
首次发布
(昨天)
主要完成日期
(14天后)
研究完成日期
(14天后)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否

Individual participant data (IPD) will not be shared because no data-sharing plan was specified in the study protocol or informed consent process.

是否有结果
否

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