Supporting physical activity engagement in people with Huntington's disease (ENGAGE-HD): study protocol for a randomized controlled feasibility trial.

Supporting physical activity engagement in people with Huntington's disease (ENGAGE-HD): study protocol for a randomized controlled feasibility trial.
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DOI:
10.1186/1745-6215-15-487
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发表时间:
2014-12-12
期刊:
影响因子:
2.5
通讯作者:
Hood K
Hood K
中科院分区:
医学4区
文献类型:
--
作者:
Busse M;Quinn L;Dawes H;Jones C;Kelson M;Poile V;Trubey R;Townson J;Edwards RT;Rosser A;Hood K

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亨廷顿氏病(HD)是一种复杂的单基因遗传性神经退行性疾病,其症状发生在广泛的神经系统领域,包括认知、行为和运动。定期进行体育活动对HD患者的益处已得到广泛认可。然而,一些因素可能会阻止持续的锻炼和活动。本试验的目的是探索针对早中期HD患者的身体活动干预计划的可行性、可接受性和有效性。拟定试验是一项体力活动干预的单盲、多中心、探索性、随机对照可行性试验。将招募总共62名遗传学确诊的HD受试者。每名受试者将参与试验26周。基线评估后,受试者将立即随机分配至体力活动干预或社会接触控制干预。身体活动干预是围绕置于更广泛的行为改变轮框架内的自决理论制定的。将在六次1:1会议上使用HD特定工作簿和个人目标设定,并进行临时电话呼叫。所有参与者将在基线评估后16周接受重新评估,并在26周后的最终随访评估中再次接受评估。在研究结束时,所有参与者都将获得替代干预的简要版本,包括一次家访和一次随访电话。让HD患者参与并支持他们参加定期的体育活动计划会带来许多挑战。在与HD患者及其家人协商后,开发了身体活动干预和比较社交互动干预。每个都是单独定制的,并根据个人的需求和目标确定。本试验的结果将为确定性试验的开发提供指导。该试验于2014年3月13日在ISRCTN(http://www.isrctn.com/ISRCTN65378754)注册。
Huntington’s disease (HD) is a complex, single-gene inherited neurodegenerative condition resulting in symptoms that occur across a wide range of neurological domains, including cognitive, behavioral and motor. The benefits of regular physical activity for people with HD are widely recognized. However, a number of factors can prohibit sustained exercise and activity. The purpose of this trial is to explore the feasibility, acceptability and effectiveness of a physical activity intervention program targeted for people with early- to mid-stage HD. The proposed trial is a single blind, multisite, exploratory, randomized controlled feasibility trial of a physical activity intervention. A total of 62 participants with genetically confirmed HD will be recruited. Each participant will be involved in the trial for 26 weeks. Participants will be randomized immediately following the baseline assessment into either a physical activity intervention or a social contact control intervention. The physical activity intervention is framed around self-determination theory placed within a broader behaviour change wheel framework. An HD-specific workbook and individual goal setting will be utilized over six 1:1 sessions, with interim telephone calls. All participants will be reassessed at 16 weeks following the baseline assessment, and then again at a final follow-up assessment 26 weeks later. At the end of the study, all participants will be offered a brief version of the alternative intervention, with one home visit and one follow-up telephone call. Engaging and supporting people with HD in a regular physical activity program raises a number of challenges. The physical activity intervention and the comparator social interaction intervention have been developed following consultation with people with HD and their families. Each are individually tailored and determined on individual needs and goals. The results from this trial will provide guidance for the development of definitive trials. The trial was registered with ISRCTN ( http://www.isrctn.com/ISRCTN65378754) on 13 March 2014.
DOI: 10.1186/1748-5908-6-42
发表时间: 2011-04-23
期刊: Implementation science : IS
影响因子: --
作者:
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DOI: 10.1093/gerona/55.6.m350
发表时间: 2000-06-01
影响因子: 5.1
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DOI: 10.1016/j.brainresbull.2006.10.021
发表时间: 2007-04-30
影响因子: 3.8
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DOI: 10.2522/ptj.20100438
发表时间: 2012-01-01
期刊: PHYSICAL THERAPY
影响因子: 3.2
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DOI: 10.1080/00952990903005882
发表时间: 2009
期刊: The American journal of drug and alcohol abuse
影响因子: --
作者:
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通讯作者: Connell AM