Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease
追踪信息 | |||
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首次提交日期 ICMJE | September 10, 2018 | ||
首次发布日期e ICMJE | October 4, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | May 21, 2018 | ||
预计主要完成日期 | September 1, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Change from Baseline Moderate-Vigorous Physical Activity using Actigraph at 4 months[ Time Frame: baseline and 4 months ] Measured using Actigraph accelerometer, levels of moderate-vigorous physical activity will be measured, as well as number of steps and sedentary behavior. Change from baseline in the Relative Autonomy Index (RAI) of the Behavioural Regulation In Exercise Questionnaire (BREQ-2) at 4 months[ Time Frame: baseline and 4 months ] The BREQ-2 is a 19-item questionnaire that measures each of the subscales of the self-determination continuum: external, introjected, identified, and intrinsic regulations, as well as amotivation. Each subscale is represented by 4 questions, except for introjected regulation which has 3. Questions are scored using a 5-point Likert scale; Answers range from 0 (not true for me) to 4 (very true for me). Subscale scores (sum totals of the 3 or 4 questions) will be reported and compared across participants. Subscales have a maximum score of 16 (12 for introjected regulation) and a minimum score of 0. An overall score (RAI-score, Relative Autonomy Index) for motivation quality will also be constructed. This is done by weighting each regulation subscale and summing them. The relative RAI is a single score derived from the subscales that gives an index of the degree to which respondents feel self-determined. Higher RAI scores denote more self-determined (autonomous) motivation. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease | ||
正式标题 ICMJE | Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Improving Self-efficacy, Automaticity, and Physical Activity Levels in People With Parkinson's Disease | ||
简要概况 | The purpose of this study is to assess the feasibility, in regards to acceptability and implementation, of the Pre-Active PD intervention for increased high intensity goal-directed aerobic exercise engagement in people with early-stage Parkinson's disease (Hoehn and Yahr stage I & II). In addition, the study aims to explore the effect estimates of the Pre-Active PD intervention on self-efficacy, motivation, stage of behavior change, and physical activity levels in people with early stage Parkinson's disease. |
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详细说明 | The investigators will recruit 14 individuals with early stage Parkinson's disease (Hoehn and Yahr stage I & II). We will conduct a single arm cohort. (pre and post intervention) pilot feasibility study over 4 months with embedded process analyses of Preactive-HD, a physical activity coaching intervention program. Previous studies conducted by the investigators will be utilized to adapt the Engage-HD physical activity coaching program to people with early stage PD. The intervention will include a participant/coach interaction and disease-specific workbook grounded within the framework of self-determination theory. The coaching sessions will be conducted by an occupational therapist and will entail six coaching sessions (either face-to-face or remote video sessions via secure Webex connection via computer or smart phone, or phone call if internet/smart phone is not available to participant). The first session (approximately 45 min) will lay the groundwork for the program, and the remaining sessions will serve to provide directed support in relation to regular physical activity and exercise. Participants will develop physical activity goals and will be supported with individual physical activity progression. Participants will be given Fitbit devices as a motivational tool and to track activity progression. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | Phase 1/Phase 2 | ||
研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: Single arm cohort study with pre and post intervention assessments 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
12 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | September 1, 2019 | ||
预计主要完成日期 | September 1, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: 1. Neurologist confirmed clinical dx for Parkinson's disease Hoehn & Yahr stage I or II 2. Ambulatory for indoor and outdoor mobility without assistance or assistive device 3. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) (Thomas et al., 1992), or medical clearance from GP Exclusion Criteria: 1. Musculoskeletal injury that would prevent participation in an exercise program 2. Other neurological disease or disorder such as stroke 3. Already engaging in aerobic exercise for at least 30 minutes for 5 or more days per week. | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:85 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United States | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Lori Quinn,Teachers College, Columbia University | ||
研究赞助商 ICMJE | Teachers College, Columbia University | ||
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研究员 ICMJE |
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PRS 账户 | Teachers College, Columbia University | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |