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临床试验/NCT03458026
NCT03458026已完成不适用

Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity "

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2018年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Number of pushes brought reported by the patient through a filled auto-questionnaire every week

研究概览

简要总结

By this project, the investigators are going to try to demonstrate that to use objects connected to make a physical activity can have an impact on the clinical activity of the disease by bringing the subjects which present a spondyloarthritis to make a physical activity. The investigators shall show furthermore, than the use of connected objects also has better chances to glue the patients presenting a spondyloarthritis to a practice of regular physical activity that a simple recommendation.

详细描述

This project is aimed at subjects with Axial Spondyloarthritis and / or peripheral of the Alpes Maritimes and more specifically of the city of Nice and its surroundings. The subjects will be recruited by the hospital doctors (consultations, hospitalization). Patients will benefit from an inclusion visit in order to explain the protocol, sign the study consent and eliminate a possible contraindication to physical activity. Knowing that this is a physical activity adapted to the health of people and their physical abilities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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
否

入选标准

  • •Presenting a spondyloarthritis according to the criteria of the ASAS (l'Assessment of SpondyloArthritis international Society)
  • •Benefiting from a stable treatment by biotherapies for at least 3 months

排除标准

  • •Patient presenting a cardiac pathology should be decompensating
  • •Patients having a contraindication in the physical activity
  • •Lung affection making impossible the effort
  • •Patient already realizing a physical activity supervised in club or with sports coach

研究组 & 干预措施

connected object + SMS of physical activity reminders

Experimental

The patients will be included during their visit of follow-up and will receive a watch connected. They will have an information meeting for their to explain how step shows it. They will also receive advice to practise an adapted physical activity. During 12 weeks of SMS (text messages) every week to motivate them to realize these exercises.

At the end of 12 weeks the connected watch will be deprived of them as well as SMS (text messages). They will have to realize an activity in autonomy during 12 weeks.

At the end of the twenty-fourth week, they will get back their watch. They will have in more 1 session with a coach and 2 sessions to be made in autonomy during 12 weeks.

In 36 week, they return the watch and finish the study.

干预措施: Connected object use combined with SMS (text messages) of physical activity reminders (Other)

Without connected object

Other

The patients will be included during their visit of follow-up.They will have an information to practice suitable activity during 12 weeks At the end of 12 weeks, they realised follow-up. They will have to realize an activity in autonomy during 12 weeks.

At the end of the twenty-fourth week, they will have 1 session with a coach and 2 sessions to be made in autonomy during 12 weeks.

In 36 week, the study will be finished.

干预措施: Without connected object (Other)

结局指标

主要结局

Number of pushes brought reported by the patient through a filled auto-questionnaire every week

时间窗: After 12 weeks

This questionnaire containing 3 items: did you present a push of your disease since the last filling of the questionnaire?,not, yes during 1 in 3 in the daytime,yes more than 3 days

次要结局

  • Moderators of the membership will be estimated thanks to the EMAPS (Scale of Motivation for Physical activity for health purposes) and thanks to the Big five(12 weeks)
  • The level of commitment in the physical activity will be estimated by the questionnaire GPAQ (Global Physical Activity Questionnaire)(12 weeks)
  • The function will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)(12 weeks)
  • The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)(36 weeks)
  • The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)(36 weeks)
  • The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)(36 weeks)
  • The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)(12 weeks)
  • The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)(12 weeks)
  • The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)(12 weeks)
  • The activity of the disease will be estimated by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)(24 weeks)
  • The activity of the disease will be estimated by the BASFI (Bath Ankylosing Spondylitis Fonctional Index)(24 weeks)
  • The activity of the disease will be estimated by the ASQOL (Ankylosing Spondylitis Quality of Life Questionnaire)(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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