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Implementing Physical Activity Guidelines for Adults With MS

2018年5月29日 更新者:McMaster University

A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.

The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life.

This randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.

研究概览

研究类型

介入性

注册 (实际的)

94

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Hamilton、Ontario、加拿大、L8S 4K1
        • McMaster University, Physical Activity Centre for Excellence
      • Kingston、Ontario、加拿大、K7L 3N6
        • Queens University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosis of MS with mild-moderate disability (EDSS 1-7)
  • Aged 18-60
  • Medical clearance to participate in physical activity

Exclusion Criteria:

  • current participation in regular physical activity (at least twice-weekly)
  • other serious medical condition that might impair ability to participate in strength or aerobic exercise

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Direct Referral to Physical Activity
The REF group will be referred to a centre-based community exercise program in their respective community (either the MacWheelers or Revved Up) by a clinical neurologist where they will be prescribed exercise based on the PAGs for adults with MS, and according to their individual capabilities.
Participants randomized to the Direct Referral to Physical Activity Arm will be provided with a referral to a physical activity program in their community and will be closely monitored in this program for 16 wks.
无干预:Control
The CON group will be provided with a print copy of the PAGs and a link to an online resource for physical activity information.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Adherence to the Physical Activity Guidelines
大体时间:3 years
Adherence to the physical activity guidelines will be analyzed by having participants fill in a weekly physical activity log that will be sent to them by email.
3 years

次要结果测量

结果测量
措施说明
大体时间
Physical Fitness
大体时间:At baseline and after the 16 week intervention
Peak oxygen uptake, maximum muscle strength, bodyweight
At baseline and after the 16 week intervention
Perceived Quality of Life
大体时间:At baseline and after the 16 week intervention
Multiple Sclerosis Quality of Life (MSQoL) scale
At baseline and after the 16 week intervention
Fatigue
大体时间:At baseline and after the 16 week intervention
Multiple Sclerosis Fatigue Impact Scale (MSFIS)
At baseline and after the 16 week intervention
Mobility
大体时间:At baseline and after the 16 week intervention
25ft walk test
At baseline and after the 16 week intervention
Blood markers of cardiovascular disease risk
大体时间:At baseline and after the 16 week intervention
blood lipid panel, HbA1c, fasting glucose
At baseline and after the 16 week intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Audrey L Hicks, Ph.D.、McMaster University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年5月1日

初级完成 (实际的)

2018年3月31日

研究完成 (实际的)

2018年3月31日

研究注册日期

首次提交

2014年3月24日

首先提交符合 QC 标准的

2014年3月26日

首次发布 (估计)

2014年3月31日

研究记录更新

最后更新发布 (实际的)

2018年5月31日

上次提交的符合 QC 标准的更新

2018年5月29日

最后验证

2018年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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