MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Six minute walk test
研究概览
简要总结
The aims of this study are to determine whether neuromuscular stimulation (NMES) of the quadriceps muscle is acceptable to patients with Idiopathic Pulmonary Fibrosis (IPF) and staff and whether it can impact clinical and healthcare resource usage outcomes.
.
详细描述
Patients with IPF who consent to participate in the study will be allocated by chance to use 'active' or 'sham/placebo' NMES for six weeks. Patients will also complete a home exercise programme and receive advice on how to manage breathlessness. Clinical outcomes and trial flow after this six week programme and six weeks after patients have stopped using NMES will be assessed. After this point, healthcare resource use during the study period will be evaluated and interviews involving participants, their carers, and staff about their experiences of the study and using or delivering NMES will be conducted.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IPF according to international standards.
- •Severe respiratory disability / breathlessness (Medical Research Council dyspnoea score ≥3).
- •Able to provide written informed consent.
- •Declined or failed to complete a supervised centre-based pulmonary rehabilitation (PR) programme
- •Quadriceps maximum voluntary contraction <80% predicted.
排除标准
- •Cardiac pacemaker.
- •Co-existing neurological condition.
- •Change in medication or exacerbation requiring admission in preceding four weeks.
- •Current regular exerciser (structured supervised training ≥3 times per week within last month).
- •People who have completed PR in the previous six months.
结局指标
主要结局
Six minute walk test
时间窗: Six weeks
Exercise capacity
次要结局
- Quadriceps maximum voluntary contraction(Six weeks and twelve weeks)
- King's Brief Interstitial Lung Disease questionnaire(Six weeks and twelve weeks)
- Rectus-femoris cross-sectional area(Six weeks and twelve weeks)
- Six minute walk test(Twelve weeks)