Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients responding to the "ASAS 20" criterion at 3 months
研究概览
简要总结
The primary objective of the study is to demonstrate the beneficial effect of a 3 months home-based physical exercise program supervised by online videos, in addition to the usual recommendations, in comparison with usual physical activity as recommended by the WHO.
The secondary objectives of the study are :
- to compare the following criteria between 2 groups at 3 and 6 months:
- quality of life;
- other measures of disease activity ;
- sleep quality ;
- walking ability
- muscle strength of;
- professional activity;
- cost of cares;
- evolution of weight, BMI and waist.
- to evaluate the observance of physical activity program and its tolerance at 3 and 6 months.
详细描述
The spondyloarthritides are a group of inflammatory rheumatic diseases, including ankylosing spondylitis, reactive arthritis, inflammatory bowel disease-related rheumatic disease, and psoriatic arthritis.
The frequence of axial spondyloarthritis is 0.41% in the french population. This disease is associated with a reduction of physical capacities and quality of life. NSAIDs or even biologic therapies do not always permit a sufficient control of the disease. Different physical exercise programs can be effective as an additional therapy for spondyloarthritis, with positive effects on spinal mobility as well as main disease activity and functional indices (BASDAI, BASFI and BASMI). The severity of the disease does not seem to influence significantly the patients' motivation in practicing physical activity.
This proposed study aims to demonstrate the beneficial effect of physical exercises coached with a specific internet program diffused on a secured platform.
Each patient will have to connect 3 times weekly in order to follow the entire program.
The impact will be evaluated at 3 months and 6 months.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 18 and 65 years;
- •Patient can read and understand French;
- •Signed informed consent form to participate in the study;
- •Axial spondylarthritis according to ASAS criteria;
- •Patient with a BASDAI score between 2.5 and 5;
- •No change of biotherapy anti-TNF or anti-IL17 during the 3 months preceding the inclusion;
- •Patient equipped with an internet access;
- •Medical certificate of proposed physical activities.
排除标准
- •All diseases (cardiovascular disease or chronic neurological disease or others) contraindicating the requested exercises according to physician;
- •Axial spondyloarthritis in remission defined by a BASDAI < 2.5/10 or in excessive inflammatory activity, defined by BASDAI > 5/10;
- •Pregnant woman (positive pregnant test) or woman try to conceive in following 6 months;
- •Patient with articular prosthesis;
- •Patient who already participate in a specific exercise program or practice a sport (including Yoga or Tai Chi) more than one hour per week;
- •Severe obesity ( BMI > 35);
- •Patient without health insurance;
- •Patient legally unable.
研究组 & 干预措施
Intervention group: video coaching exercises
Video coaching exercises group: patients will perform physical exercises according to a video coaching program 3 times weekly during 6 months. The on-line program has been designed especially for this study.
干预措施: Video coaching exercises (Other)
Control group: routine exercises
Routine method advising and encouraging patients to perform physical activities according to the WHO recommendations during 3 months then to follow the video coaching physical exercises program during 3 months.
干预措施: Routine exercises (Other)
结局指标
主要结局
Proportion of patients responding to the "ASAS 20" criterion at 3 months
时间窗: at 3 months
The primary outcome measure will be the proportion of patients simultaneously satisfying both criteria : * at least 20% improvement * improvement of at least 10 points on visual analog scale in the following domains: overall evaluation by the patient, visual analog scale (pain scale), Bath Ankylosing Spondylitis Functional Index (BASFI), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
次要结局
- Bath Ankylosing Spondylitis Functional Index (BASFI) (PRO)(at baseline, 3 months and 6 months)
- Fatigue (PRO)(at baseline, 3 months and 6 months)
- Health assessment: HAQ-S (PRO)(at baseline, 3 months and 6 months)
- Work Productivity and Activity : WPAI (PRO)(at baseline, 3 months and 6 months)
- Sleep quality: PSQI(at baseline, 3 months and 6 months)
- Anthropometric measures: Body mass index (BMI)(at baseline, 3 months and 6 months)
- Ankylosing Spondylitis Disease Activity : (BASDAI) (PRO)(at baseline, 3 months and 6 months)
- Ankylosing Spondylitis Disease Activity : (ASDAS CRP) (PRO)(at baseline, 3 months and 6 months)
- Analgesic and anti-inflammatory drug intake(at 3 months and 6 months)
- Anthropometric measures: Muscle strength: dynamometer(at baseline, 3 months and 6 months)
- SPA impact on general health: ASAS-HI (PRO)(at baseline, 3 months and 6 months)
- Physical activity: IPAQ (PRO)(at baseline, 3 months and 6 months)
- Anthropometric measures: 6-minutes walk test(at baseline, 3 months and 6 months)
- Anthropometric measures: BASMI(at baseline, 3 months and 6 months)
- Anthropometric measures: Enthesitis: MASES(at baseline, 3 months and 6 months)