Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease and Research for Predictive Factors of Fall Risk.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of the Timed Up and Go test and the Berg Balance scale
研究概览
简要总结
The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.
The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.
详细描述
We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.
The patients will be proposed to perform the following tests and to fill in questionnaires:
- Questionnaires: Elderly Falls Screening Test to quantify the falls in the last year, Hospital Anxiety and Depression Scale, Activities-specific Balance Confidence scale.
Tests:
- Berg Balance Scale measuring balance in 14 different functional tasks (abnormal cut-off value <56)
- Timed Up and Go evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
- 6 minute walk test evaluating endurance to submaximal exercise.
- Isokinetic maximal force of the quadriceps at 60°/s
- Balance control: posturography consisting in measuring variations when standing on a force platform.
- Body composition assessment through Dual Xray Absorptiometry (DXA), to measure body muscle mass and more specifically appendicular muscle mass index as a criteria of sarcopenia, and bone mineral density.
- Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD confirmed by pulmonary function tests
- •Long term oxygen therapy since at least 3 months in the LOT+ subgroup
排除标准
- •Exacerbation of COPD necessitating an hospitalization or an oral corticosteroid treatment, in the last 4 weeks
- •Pulmonary rehabilitation in the last 3 months
- •Any neurological disease affecting balance control.
- •Inability to perform a walk test
结局指标
主要结局
Comparison of the Timed Up and Go test and the Berg Balance scale
时间窗: at day 1
Comparison of the consistency of abnormal value of the Timed Up and Go test and the Berg Balance scale
次要结局
- Identify predictive factors of fall risk(at day 1)
- Sensitivity of the TUG test and the BBS(at day 1)
- Difference in BBS score(at day 1)