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临床试验/NCT03306888
NCT03306888已完成1 期

Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage Huntington's Disease

Teachers College, Columbia University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2017年10月10日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
14
试验地点
1
主要终点
Change in physical activity (daily step counts) at 4 months

研究概览

简要总结

This study will evaluate the feasibility and acceptability of a clinic-based physical activity coaching intervention in people with pre-manifest and early stage Huntington's Disease (HD). Fourteen individuals with premanifest and early stage HD will be recruited to participate in a 4 month coaching intervention. Feasibility will be assessed by recruitment and retention rates, and acceptability will be assessed by participant interviews. Participants will also be evaluate at baseline and following the coaching intervention to explore preliminary efficacy in terms of physical activity, self efficacy, disease-specific motor and cognitive function, walking endurance and strength.

详细描述

The investigators have previously developed and evaluated a physical activity behavioral change intervention in people with early-mid stage HD (Engage-HD). In a study conducted in the United Kingdom, self-reported physical activity, self-efficacy for exercise, and cognition were increased for those in the coaching intervention group compared to a social contact control group. This intervention has not yet been applied to individuals with pre-manifest (prior to onset of clinical symptoms) and early stage HD, where it may be most critical to engage in exercise. To date, no study has prospectively evaluated a physical activity intervention to facilitate exercise uptake in these earliest stages. This study will explore the feasibility and acceptability of the Engage-HD intervention in 14 individuals with pre-manifest and early stage HD. The intervention will entail one face-to-face coaching session (approximately 1 hour), and three remote video sessions (via secure Webex connection via computer or smart phone, or phone call if internet/smart phone is not available to participant) lasting approximately 20 minutes. Participants will also be given FitBit wearable activity monitors to allow for self- monitoring of physical activity for use during the 4-month intervention. Participants will be evaluated at baseline and again 4 months later on a range of exploratory outcomes including physical activity, self efficacy, disease-specific motor and cognitive function, walking endurance and strength. Results from this study will be used to make relevant adaptations to prepare for a multi-site randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For premanifest - Confirmatory genetic testing for Huntington disease (HD) and diagnostic confidence score of 0-3 on Unified Huntington Disease Rating Scale, indicating pre-manifest disease state. For manifest HD - Confirmatory genetic testing for HD or confirmed clinical diagnosis of HD by neurologist
  • Successful completion of Physical Activity Readiness Questionnaire (PAR-Q), or medical clearance from General Practioner
  • For potential participants over age 60, a minimum score of 24 on the Mini-Mental State Examination (MMSE) (completed within 3 months) will be required for capacity to consent.
  • For potential participants age 60-65, successful pass of electrocardiogram screen will be required.

排除标准

  • Musculoskeletal injury that would interfere with participation in an exercise program
  • Currently participating in a structured exercise program 3 times per week or more
  • Uncontrolled psychiatric or behavioral problems that would interfere with participation in an exercise program

结局指标

主要结局

Change in physical activity (daily step counts) at 4 months

时间窗: 4 months

Physical activity as measured by waist worn device (Actigraph)

次要结局

  • Change in grip strength at 4 months(4 months)
  • Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months(4 months)
  • Change in HD-PRO-TRIAD at 4 months(4 months)
  • Change in Unified Huntington Disease rating scale Total Motor Score at 4 months(4 months)
  • Change in Lorig self efficacy scale at 4 months(4 months)
  • Change in 6 minute walk distance at 4 months(4 months)
  • Change in Behavioral Regulation in Exercise Questionnaire (BREQ 2) at 4 months(4 months)
  • Change in Unified Huntington Disease Rating Scale Cognitive battery at 4 months(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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