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Resistance Exercise in Rheumatic Disease

2019年4月5日 更新者:Johns Hopkins University
People with rheumatic disease often have decreased strength, muscle mass, and bone mineral density due to repeated bouts of inflammation, normal effects of aging, disuse, and inactivity. The medications used to quell the disease process, such as prednisone, can also have detrimental effects on body composition, strength, and functional capacity. The investigators propose to investigate the feasibility, safety, and effects of resistance exercise in older patients with rheumatoid arthritis (RA) and vasculitis. The unique resistance protocol the investigators propose involves performing movements in a slow and controlled fashion (i.e., no acceleration or use of momentum in the lifting and lowering of the resistance) to minimize force on the joints and connective tissues. This will be conducted in an individually-supervised environment with a new generation of exercise equipment that will accommodate their musculoskeletal capabilities and allow for reproducibility of the exercise protocol. The investigators intend to investigate the feasibility, safety, musculoskeletal, and psychological effects of this resistance exercise protocol in older patients with rheumatoid arthritis and vasculitis by testing their strength, body composition, functional ability, mood, and quality of life before and after this 16-week resistance exercise intervention.

研究概览

研究类型

介入性

注册 (实际的)

15

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

    • Maryland
      • Baltimore、Maryland、美国、21224
        • Johns Hopkins Bayview Medical Campus

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

45年 至 85年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • diagnosis of rheumatoid arthritis OR systemic vasculitis (defined as granulomatosis with polyangiitis, Churg-Strauss, microscopic polyangiitis, Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, or giant cell arteritis)

Exclusion Criteria:

  • Non-English speaking
  • Pregnancy
  • Absolute cardiac or pulmonary contraindication to exercise
  • pacemaker

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:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 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:Resistance Exercise
Subjects will participate in a 16 week long resistance exercise program which will consist of 2 30-minute individually supervised sessions per week.
Two 30-minute individually supervised exercise sessions per week for 16-weeks

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
Number of participants with rheumatoid arthritis flares during the study
大体时间:up to 16 weeks
Participants will be provided with questionnaires. They will be asked to report the number of arthritis flares since the last visit. Arthritis flares consist of pain and swelling of the joints. The total number of flares during the 16 week study will be reported.
up to 16 weeks
Number of participants with reported physical injuries during the study
大体时间:up to 16 weeks
Participants will be provided with questionnaires. They will be asked to report the number of injuries associated with the last visit (e.g. strains, sprains, and pulled muscles). The total number of injuries during the 16 week study will be reported.
up to 16 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in Body composition after 16 weeks of resistance exercise
大体时间:16 weeks
To assess change in body composition associated with this resistance exercise protocol (after 16 weeks).
16 weeks
Change in Strength after 16 weeks of resistance exercise
大体时间:16 weeks
We will test if strength increases before and after the exercise intervention
16 weeks
Change in Functional status after 16 weeks of resistance exercise
大体时间:16 weeks
We will determine if functional status, as measured by the short physical performance battery, improves after 16 weeks
16 weeks
Change in inflammatory cytokine Interleukin-6 (IL6) after 16 weeks of resistance exercise
大体时间:16 weeks
Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokine.
16 weeks
Change in inflammatory cytokine C-reactive protein (CRP) after 16 weeks of resistance exercise
大体时间:16 weeks
Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokine.
16 weeks
Change in Erythrocyte Sedimentation Rate (ESR) after 16 weeks of resistance exercise
大体时间:16 weeks
Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their ESR
16 weeks

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:Rebecca L Manno, M.D.、Johns Hopkins University

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)

2012年5月1日

初级完成 (实际的)

2018年12月1日

研究完成 (实际的)

2018年12月1日

研究注册日期

首次提交

2012年5月7日

首先提交符合 QC 标准的

2012年5月14日

首次发布 (估计)

2012年5月15日

研究记录更新

最后更新发布 (实际的)

2019年4月9日

上次提交的符合 QC 标准的更新

2019年4月5日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

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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