Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study.
Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study.
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DOI：
10.1136/bmjopen-2021-048808
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发表时间：
2021-06-02
期刊：
影响因子：
2.9
通讯作者：
Man WD
中科院分区：
文献类型：
--
作者：
Nolan CM;Patel S;Barker RE;Walsh JA;Polgar O;Maddocks M;George PM;Renzoni EA;Wells AU;Molyneaux PL;Kouranos V;Chua F;Maher TM;Man WD
评估特发性肺纤维化（IPF）患者四头肌神经肌肉电刺激（NMES）的可接受性，并确定未来确定性试验是否可行。一项随机、平行、两组、受试者和评估者设盲、安慰剂对照可行性试验，包括嵌入式定性访谈。皇家布朗普顿和哈里菲尔德医院门诊部。22名IPF患者：中位数（第25，75百分位数）年龄76（74，82）岁，用力肺活量62（50，75）%预测值，6分钟步行测试距离289（149，360）m。使用安慰剂或活性NMES进行为期6周的康复护理（家庭锻炼、每周电话支持、呼吸困难管理传单），并在第6周和第12周进行随访。招募和保留的可行性、治疗接受和依从性、结局评估、受试者和结局评估者设盲以及与干预相关的不良事件。在确定性临床试验中可能成为主要或次要结局的结局指标。此外，有目的地抽样的参与者进行了采访，以捕捉他们的经验和试验的可接受性。在筛选的364人中，招募了23人：每组11人，一人在随机分配前退出。与对照组相比，更大比例的干预组完成了干预，留在试验中不知道组分配，并经历了干预相关的不良事件。保持评估者盲态。次要结局指标是可行的，大多数缺失数据与加速计相关。参与者人数少，无法确定适合确定性试验的结局指标。定性结果表明，试验过程和活性NMES是可接受的，但对安慰剂NMES的可信度存在担忧。首先由于招募困难，使用当前方案评价IPF患者的NMES的确定性试验不可行。NCT 03499275。
To assess the acceptability of neuromuscular electrical stimulation (NMES) of the quadriceps muscles in people with idiopathic pulmonary fibrosis (IPF) and to identify whether a future definitive trial is feasible. A randomised, parallel, two-group, participant and assessor-blinded, placebo-controlled feasibility trial with embedded qualitative interviews. Outpatient department, Royal Brompton and Harefield Hospitals. Twenty-two people with IPF: median (25th, 75th centiles) age 76 (74, 82) years, forced vital capacity 62 (50, 75) % predicted, 6 min walk test distance 289 (149, 360) m. Usual care (home-based exercise, weekly telephone support, breathlessness management leaflet) with either placebo or active NMES for 6 weeks, with follow-up at 6 and 12 weeks. Feasibility of recruitment and retention, treatment uptake and adherence, outcome assessments, participant and outcome assessor blinding and adverse events related to interventions. Outcome measures with potential to be primary or secondary outcomes in a definitive clinical trial. In addition, purposively sampled participants were interviewed to capture their experiences and acceptability of the trial. Out of 364 people screened, 23 were recruited: 11 were allocated to each group and one was withdrawn prior to randomisation. Compared with the control group, a greater proportion of the intervention group completed the intervention, remained in the trial blinded to group allocation and experienced intervention-related adverse events. Assessor blinding was maintained. The secondary outcome measures were feasible with most missing data associated with the accelerometer. Small participant numbers precluded identification of an outcome measure suitable for a definitive trial. Qualitative findings demonstrated that trial process and active NMES were acceptable but there were concerns about the credibility of placebo NMES. Primarily owing to recruitment difficulties, a definitive trial using the current protocol to evaluate NMES in people with IPF is not feasible. NCT03499275.
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DOI：
10.1183/09031936.00104909
发表时间：
2010-07
期刊：
The European respiratory journal
影响因子：
--
作者：
Seymour JM;Spruit MA;Hopkinson NS;Natanek SA;Man WD;Jackson A;Gosker HR;Schols AM;Moxham J;Polkey MI;Wouters EF
通讯作者：
Wouters EF
影响因子：
6.9
作者：
Nolan, Claire M.;Maddocks, Matthew;Man, William D. -C.
通讯作者：
Man, William D. -C.
影响因子：
4
作者：
Gale NK;Heath G;Cameron E;Rashid S;Redwood S
通讯作者：
Redwood S
影响因子：
6.9
作者：
Holland, Anne E.;Fiore, Julio F., Jr.;Glaspole, Ian
通讯作者：
Glaspole, Ian
DOI：
10.1164/rccm.2009-040gl
发表时间：
2011-03-15
影响因子：
24.7
作者：
Raghu, Ganesh;Collard, Harold R.;Schuenemann, Holger J.
通讯作者：
Schuenemann, Holger J.