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临床试验/NCT02165150
NCT02165150已完成不适用

Development, Application , and Evaluation of the Senior Elastic Band (SEB) Exercise Program for Elderly Residents in Long-term Care Facilities

Kaohsiung Medical University1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2010年8月1日最近更新:
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
127
试验地点
1
主要终点
Change from baseline in physical functional fitness at 3, 6, 9, 12, 15 months

研究概览

简要总结

The goals of this research project are: 1) to develop and evaluate the safety and feasibility of the Senior Elastic Band (SEB) exercise program for elderly residents in long term care facilities, 2) to evaluate the long-term effects of the SEB on physical functional fitness and sleep quality of elderly residents in long term care facilities, and 3) to investigate the compliance of elderly residents with long-term SEB exercises.

详细描述

A three-year, longitudinal, triangulation research method will be used. The study purpose of the first year is to develop a safe and appropriate SEB program for the elderly residents in long term care facilities using Delphi survey with a panel of 12 experts and pilot-testing on a group of 15-20 elderly residents in long term care facilities. In the second year of the study, a quasi-experimental, non-equivalent control group design will be used to evaluate the effects of the SEB exercise program on the physical functional fitness (cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance) and sleep quality of elderly residents in long term care facilities. Through the convenience sampling strategy, a total of four long term care facilities with approximately 120 elders in Kaohsiung will be recruited and randomly assigned based on the resided facilities to a SEB experimental group or a waiting-list control group. The subjects in the experimental group will receive the SEB interventions lead by the certified instructors, three times per week, 40 minutes per practice for six months; the subjects in the waiting-list control group will remain regular daily activities in the facilities. All subjects will receive one pre-test and two post-tests three months apart during the study. In the third year, the elderly participants will continue practicing the SEB guided by a VCD for another nine months, and the compliance of the participants toward regular SEB exercise and its long-term effects on the physical functional fitness and sleep quality outcomes will be tested with additional three post-tests, three months apart.

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
None

入排标准

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

入选标准

  • •elderly residents aged 65 and over
  • •Mandarin or Taiwanese speakers
  • •have been living in the facility for at least 3 months
  • •able to stand alone without assistive devices
  • •cognitively alert and able to verbally state their name, address, and answer questions.

排除标准

  • •participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses

研究组 & 干预措施

Wheelchair-bound Senior Elastic Band

Experimental

WSEB interventions three times per week, 40 minutes per practice

干预措施: Wheelchair-bound Senior Elastic Band exercise program (Other)

Control

No Intervention

routine care

结局指标

主要结局

Change from baseline in physical functional fitness at 3, 6, 9, 12, 15 months

时间窗: participants will be followed for 15 months

including cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance

次要结局

  • Change from baseline in sleep quality at 3, 6, 9, 12, 15 months(participants will be followed for 15 months)
  • Change from baseline in depression at 3, 6, 9, 12, 15 months(participants will be followed for 15 months)

研究者

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

Kuei-Min Chen, Ph.D., RN.

Professor

Kaohsiung Medical University

研究点 (1)

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Senior Elastic Band (SEB) on Institutional Elders | 临床试验