跳至主要内容
临床试验/NCT05504616
NCT05504616招募中不适用

Physical Activity in Axial Spondyloarthritis: Development and Implementation of an Evidence-Based Health Technology Approach to Improve Adherence to Recommended Guidelines

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2022年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
106
试验地点
2
主要终点
Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF)

研究概览

简要总结

Despite the known benefits of physical activity, the majority of Canadians fail to meet recommended guidelines. Patients with axial spondyloarthritis (axSpA) also fail to meet recommended guidelines. Exercise, a critical component of physical activity, is considered the cornerstone of axSpA management. Simple health technologies such as mobile phone messaging and email can be useful tools to increase engagement in regular physical activity among the general public and patients with chronic disease. As such, the aim of this research project is to develop and test a patient-centered strategy that provides education on the importance of physical activity and utilizes existing health technologies (such as smart phone applications) to encourage regular participation in physical activity. The results of this study are expected to demonstrate that patients with axSpA will increase their daily engagement in physical activity, and therefore improve symptoms, function and overall quality of life.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (aged 18 and older) with a diagnosis of axSpA based on ASAS criteria
  • Have access to email and a smart phone device (Android or iOS operating systems)
  • Enrolled in the SPARCC Research Program
  • Passes pre-participation health screen

排除标准

  • Non-English speaking
  • Not enrolled in the SPARCC Research Program
  • Comorbidities or physical impairments that may preclude physical activity (e.g., symptomatic cardiovascular disease; wheelchair bound etc.)

结局指标

主要结局

Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF)

时间窗: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.

The IPAQ-SF is a self-report questionnaire designed to estimate total physical activity in MET-min/week by assessing the types of intensity of physical activity and sitting time that people do as part of their daily lives.

Changes in exercise behaviour as measured by an adapted Stanford Exercise Behaviours Questionnaire

时间窗: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.

2-item questionnaire measuring total time (minutes) spent on stretching and strengthening exercises each week.

Change in perceived benefits and barriers to exercise as a result of the technology-based intervention strategy as measured by the Exercise Benefits/Barriers Scale (EBBS)

时间窗: Assessed at baseline and at 12 weeks.

The EBBS measures perceptions regarding the benefits of, and barriers to, exercise.

Change in functioning and health as a result of the technology-based intervention strategy as measured by the ASAS Health Index

时间窗: Assessed at baseline and at 12 weeks.

The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. The items measure the concept of 'functioning, disability and health'

Change in levels of physical activity as measured by Accelerometry

时间窗: Assessed at baseline and at 12 weeks.

Participants wear an accelerometer for 7 consecutive days at baseline and again at 12 weeks. The participant will mail back the activity monitor using a pre-paid envelope following each seven-day period.

次要结局

  • Change in disease activity over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDI) questionnaire(From baseline, assessed up to 12 weeks.)
  • Duration of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks(From baseline, assessed up to 12 weeks.)
  • Number of enrolled participants who complete the study(Assessed at 12 weeks.)
  • Acceptance of health technology-based intervention strategy, as measured by the Mobile Application Rating Scale(Assessed at 12 weeks.)
  • Change in function over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire(From baseline, assessed up to 12 weeks.)
  • Number of accepted invites over the course of 12 weeks(From baseline, assessed up to 12 weeks.)
  • Frequency of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks(From baseline, assessed up to 12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Passalent

Physiotherapist Practitioner

University Health Network, Toronto

研究点 (2)

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