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Efficacy of a Post-Rehabilitation Exercise Intervention

2013年4月22日 更新者:Alan Jette、Boston University

Background:

Many people who have suffered a hip fracture are discharged from rehabilitation services with significant residual functional limitations and disability. We believe that a home-based exercise program that incorporates cognitive-behavioral techniques to increase exercise adherence and promote the return to daily activities could extend the benefits of formal rehabilitation for patients who have suffered a hip fracture.

Specific Aims:

We will conduct a 5-year multi-site randomized controlled trial in patients who have suffered a recent hip fracture and have completed all rehabilitation services. The specific aim that this project will address is whether:

Participation in the Strong for Life (SFL) program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services.

This study will also investigate the following secondary hypotheses:

  1. Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.
  2. The SFL program will significantly improve health-related quality of life among participants at 6-month follow-up.
  3. At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.

Target population:

The target population will be people aged 60 years or more who have suffered a recent traumatic hip fracture, have one or more residual functional limitations and have completed all inpatient, outpatient or homecare rehabilitation services.

Intervention:

We will use an enhanced version of the Strong for Life program. This home-based exercise program will include both resistance exercises using Thera-bands that will be shown on a video/DVD and weight-bearing exercises that are progressed using a step and/or a weighted vest. A cognitive-behavioral program that is customized for people recovering from hip fracture is being developed that will focus on promoting exercise adherence, decreasing fear of falling and increasing the return to daily activities in the patient's home and community.

Design:

A randomized controlled clinical trial will be implemented to measure the efficacy of the Strong for Life program. An attention-control intervention will be provided to all participants assigned to the control group. The outcome evaluation points are:

  • T0: baseline, at the point of discharge from formal rehabilitation;
  • T2: 6-month outcome assessment
  • T3: 9-month follow-up

Outcomes:

The primary outcomes will be function measured by both self-report (AM PAC) and physical performance measures (SPPB). Secondary outcomes include disability, self-efficacy, balance, strength, cognition, and reaction time. Adherence to the exercise program and adverse events will also be monitored.

研究概览

研究类型

介入性

注册 (实际的)

232

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

    • Massachusetts
      • Cambridge、Massachusetts、美国、02138
        • Spaulding Rehabilitation Hospital

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

60年 及以上 (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:

  • Have a primary diagnosis of hip fracture;
  • Aged 60 years and above;
  • Have functional limitation (i.e., as determined by limitation in at least one of 9 functional tasks listed in the SF-36 physical function scale, excluding vigorous activities);
  • Have recently been discharged from rehabilitation services;
  • Be able to understand and communicate in English;
  • Be able to safely and independently stand with or without the aid of a mobility device, without needing any assistance or supervision from another person;
  • Have received written clearance from their primary care physician documenting no contra-indications for participating in the study;
  • Be able to provide written informed consent.

Exclusion Criteria:

  • Have serious cognitive deficits (i.e., a Mini-Mental State Examination score of less than 20)85;
  • Have severe depression (i.e., a score of 20 or greater on the Geriatric Depression Scale)86;
  • Have a terminal illness with survival expected to be less than 1 year;
  • Have significant pulmonary or cardiovascular contraindications or pre-existing conditions that preclude participating in an exercise program;
  • Legally blind;
  • Currently receiving rehabilitation therapy;
  • Live outside of the study's catchment area in the Boston metropolitan area and eastern Massachusetts.

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:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:1个

The program contains 5 minutes of warm-up, 25 minutes of strengthening, and 5 minutes of cool-down exercises. The SFL program is contained on a 35 minute videotape. Subjects are instructed to increase resistance when they can perform 10 repetitions of a movement pattern without significant fatigue or loss of proper execution. Subjects are instructed to move within a comfortable range of motion.

Participants will be taught the SFL program during two home visits conducted by a physical therapist. On the first visit, the exercise techniques will be taught, modified as needed based on individual needs and practiced as necessary until proper technique is attained. Each participant will be given written guidelines for how to progress resistance of the program, how to modify the exercises and how to complete bimonthly exercise calendars.

安慰剂比较:cardiovascular education (attention control)
administered as an attention control intervention using home visits, phone calls and mail-outs of 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
The specific aim that this project will address is whether: Participation in the SFL program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services.
大体时间:baseline, 6-month and 9-month follow up
performance based function is assessed using the Short Physical Performance Battery (SPPB) and self-reported function is assessed using the AM-PAC
baseline, 6-month and 9-month follow up

次要结果测量

结果测量
大体时间
Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.
大体时间:baseline, 6-month and 9-month follow up
baseline, 6-month and 9-month follow up
At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.
大体时间:baseline, 6-month and 9-month follow up
baseline, 6-month and 9-month follow up

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:Alan M Jette, PhD、Health & Disability Research Institute
  • 首席研究员:Nancy Latham, PhD、Health & Disability Research Institute

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

2008年4月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年11月1日

研究注册日期

首次提交

2008年1月2日

首先提交符合 QC 标准的

2008年1月11日

首次发布 (估计)

2008年1月14日

研究记录更新

最后更新发布 (估计)

2013年4月23日

上次提交的符合 QC 标准的更新

2013年4月22日

最后验证

2013年4月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • NINR 1R01NR010815-01A2
  • 1R01NR010815-01A2 (美国 NIH 拨款/合同)

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.

Enhanced Strong for Life的临床试验

3
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