Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Free-living Physical Activity
研究概览
简要总结
Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical activity and exercise are key components of the management of ankylosing spondylitis, however many adults with ankylosing spondylitis do not meet physical activity recommendations. This study aims to investigate the effects of a twelve week intervention designed to increase physical activity and exercise in adults with ankylosing spondylitis.
详细描述
Participants will be randomly allocated to one of two groups. An intervention group will receive individual consultations with a physiotherapist. The aim of the meetings will be to motivate and support participants on an individual basis, with the goal of increasing weekly physical activity. The second group, the control group, will continue with their current management strategies. All participants will be assessed at baseline, post-intervention (after twelve weeks) and after a three month follow-up period. The primary outcome measure will be free-living physical activity over one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ankylosing spondylitis (diagnosed by a rheumatologist).
- •Able to read and understand the English language.
- •On stable pharmacological management.
排除标准
- •Under 18 years of age, or over 64 years of age
- •Unable to read and understand the English language
- •Concomitant cardiac, respiratory or neurological condition
- •Co-morbidity restricting physical activity or inability to ambulate without a mobility aid
- •Acute lower limb injury
- •Uncontrolled epilepsy
- •Cognitive difficulties limiting ability to follow safety and protocol instructions
- •Change in medication (type of dosage) within six weeks of testing
- •On beta-blocker medication.
结局指标
主要结局
Free-living Physical Activity
时间窗: up to 12 weeks follow-up
Actigraph monitor GT3X-BT worn during waking hours over 7 days.
次要结局
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(up to 12 weeks follow-up)
- Flexibility(up to 12 weeks follow-up)
- Body Composition(up to 12 weeks follow-up)
- Muscular fitness(up to 12 weeks follow-up)
- Exercise Barriers and Beliefs Scale (EBBS)(up to 12 weeks follow-up)
- Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)(up to 12 weeks follow-up)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(up to 12 weeks follow-up)
- Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)(up to 12 weeks follow-up)
- Bath Ankylosing Spondylitis Global score (BAS-G)(up to 12 weeks follow-up)
- Cardiorespiratory capacity(up to 12 weeks follow-up)
研究者
Tom O'Dwyer
Lead Investigator
University of Dublin, Trinity College