Accelerometry in Follow up of Arthritis - a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Detection of arthritis activity status
研究概览
简要总结
This is a proof-of-concept study. The main goal is to evaluate if the accelerometry signal recorded from patients with arthritis in different disease activity stages, allows for assessment of the activity status. It will also be analysed if the accelerometry signal can be classified as registered in arthritis patients vs. registered in healthy control. Arthritis subjects will be recruited from the outpatients' clinic of the Rheumatology Department Helse Førde, Førde, Norway. Healthy control subjects will be recruited from the same administrative area as the patients and will be invited to participate via announcement on the Helse Forde Medical Trust website. Four visits to the site are planned for the arthritis group and one for the control group. The patients will be recruited in the active phase of arthritis as defined in the inclusion criteria.
The study's secondary objective is to develop methods for analysing the accelerometry signal in arthritis patients.
详细描述
Study type: Observational, proof-of-concept
Objectives:
Primary objective: To evaluate if an accelerometer signal in patients with active arthritis differs from the signal taken in inactive arthritis and healthy individuals.
Secondary goals:
- To evaluate how the accelerometer signal differs depending on the disease activity status
- To elaborate the methods for analysing accelerometry in the arthritis patients
- To build knowledge and data for future studies
- To evaluate software and hardware used
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Clinical diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondyloarthritis (SPA).
- •Planned or newly started (within 4 weeks before baseline visit) disease-modifying treatment.
- •Disis activity defined as:
- •RA - DAS28 (ESR or CRP) minimum 3.2,
- •PsA - DAPSA minimum 15,
- •SPA - BASDAI minimum 4.
- •A minimum number of tender or swollen joints:
- •RA - 4/4,
- •PsA - 2/2,
- •SPA - not applicable.
- •Subject without comorbidities defined in the exclusion criteria.
- •Willing to participate and consent competent.
- •Over 18 years old.
- •Without any inflammatory rheumatic disease
- •Without any comorbidity as defined in the exclusion criteria.
- •Willing to participate and consent competent.
- •Over 18 years old.
排除标准
- •Both patients and controls:
- •Chronic neurologic disorders such as multiple sclerosis, parkinsonism, active epilepsy, symptomatic peripheral neuropathy, sequels after radiculopathy or other central nervous system deficit.
- •Paresis after cerebral stroke (mild deficits or TIA can be allowed).
- •Serious heart failure (NYHA 3 or above).
- •Active psychotic disorder.
- •Activ alcohol or drug addiction.
- •Fast use of medicine that can significantly influence CNS function (low dose sleeping medicine 12 hours before a visit can be allowed).
- •Spinal compression fractures less than six months before baseline.
- •Other limb fractures, within 4 months before baseline if it can influence patient's mobility
- •Other medical conditions that can influence patient's mobility
结局指标
主要结局
Detection of arthritis activity status
时间窗: 2023
Analysis of raw akcelerometry will be used to detect disease activity status
次要结局
未报告次要终点
研究者
Pawel Mielnik
Consultant in Rheumatology
Helse Forde