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临床试验/NCT01277809
NCT01277809已完成不适用

Community Alliance for Quality of Life in Long Term Care: The Effects of a Walking Program on Balance, Falls and Well Being in Individuals Residing in Long-term Care

University of Saskatchewan2 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2010年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
179
试验地点
2
主要终点
Falls

研究概览

简要总结

The purpose of this study is to assess the effectiveness of a regular walking program (which inevitably involves human interaction) compared to a usual care condition and to a human interaction condition (without the extra walking program) in individuals residing in Long-Term Care (LTC). Outcomes of interest include: balance, strength, mobility, endurance, walking distance; rate and severity of falls; activities of daily living; mood and behaviour.

It is hypothesized that participants taking part in the walking program will demonstrate maximal benefits compared to the no treatment control group (usual care) and the participants who will only receive social interaction. It is expected that benefits of the walking program will include decreased fall rates, and improved balance, endurance, strength, mood, behaviour, activities of daily living and quality of life indices. Given research findings that the addition of pleasant activities improves resident mood (Teri et al, 1997; 2003), it is expected that participants in the social interaction only group will demonstrate improvements in mood and other indices of quality of life.

详细描述

Residents in LTC facilities in the Saskatoon Health Region and Regina Qu'Appelle Region will be recruited.

Inclusion criteria: Male or female residents who are able to follow simple instructions, who can ambulate with or without a walking aid for at least 10 meters, and who are willing to participate in the study procedures will be eligible to participate in the study.

Exclusion criteria: Residents who have experienced a recent cardiovascular event (within past 6 months) or have severe arthritis, cardiac instability, a vestibular disorder, uncontrolled hypertension, uncontrolled epilepsy, a recent fracture (past 4 months), who have had a recent admission into an acute care facility (past 4 months), who are scheduled for surgery or hospitalization in next 6 months or who are participating in another regular exercise program (three or more times per week) aimed at improving balance or strength will be excluded from the study.

Based on the sample size calculations, a sample size of 129 participants will provide ample power for the repeated measures analyses. Data will be collected from an additional 50 participants in order to deal with the possibility of attrition. Thus, total sample size is 179 participants.

The investigators will meet with the LTC facilities' administrators and staff to inform them of the study, inclusion and exclusion criteria, study procedures and interventions. They will be provided with copies of a one page information form which includes a space for residents (or substitute medical decision-maker, if appropriate) to indicate their signed consent to be approached by research staff with more detailed information (Appendix). Staff will provide this form to potential/eligible subjects, and will collect these forms when completed. Subjects who have consented to be contacted by research staff will be provided with more detailed information about the study by the research coordinator. If the resident is in agreement, he or she will then give written consent and will be entered into the study. The consent will include written permission for researchers to consult with the subject's family physician about the subject's health, and to ensure optimization of vitamin D intake prior to enrollment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Adults residing in a long term care facility
  • Able to follow simple instructions
  • Can ambulate with or without a walking aid for at least 10 meters
  • Willing to participate in the study procedures

排除标准

  • Exclusion criteria:
  • Cardiovascular event within past 6 months
  • Severe arthritis
  • Clinical significant vestibular disorder
  • Uncontrolled hypertension
  • Uncontrolled epilepsy
  • Fracture within the past 4 months
  • Admission into an acute care facility in last 4 months
  • Scheduled for surgery or hospitalization in next 6 months
  • Already participating in another regular exercise program (three or more times per week) aimed at improving balance or strength

研究组 & 干预措施

Usual Care

No Intervention

Participants will receive care as usual (Usual Care Group; UCG) that is provided by their long-term care unit.

Interpersonal Interaction

Active Comparator

Participants will receive stationary 1:1 interaction time with the same research personnel who conduct the third group walking session at each individual care facility in order to control for the interpersonal interaction likely to be involved in the walking program. This group will receive the equivalent interpersonal interaction time with research personnel as those participating in the walking group. This interaction time will occur with the participant stationary, rather than walking with the researcher.

干预措施: Interpersonal Interaction (Behavioral)

Walking Program

Experimental

Participants will walk five times per week under the supervision of a licensed physiotherapist.

干预措施: Walking Program (Behavioral)

结局指标

主要结局

Falls

时间窗: Eight months

The incidence and nature of falls will be prospectively collected using a simple daily Fall Diary for the period of the intervention (4 months) and for 4 months following intervention. The Fall Diary will be kept at the residents' bedside and will staff will be asked to record the nature and location of the fall, activity and symptoms at the time of the fall, type of footwear, injuries resulting from the fall. Diaries will be collected every week by study personnel.

次要结局

  • Behavioral problems(Eight months)
  • Gait speed(Eight months)
  • Fitness(Eight months)
  • Balance(Eight months)
  • Grip Strength(Eight months)
  • Physical Activities of Daily Living(Eight months)
  • Vital signs(Eight months)
  • Depression(Eight months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lilian Thorpe

M.D.

University of Saskatchewan

研究点 (2)

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