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临床试验/NCT02909374
NCT02909374Unknown不适用

"Stay Balanced" - Prevention of Falls in Older Adults Through Implementation of Evidence Based Balance Training - From Clinical Research to Clinical Practice

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Sustainability of the balance training programme in clinical setting

研究概览

简要总结

Fall is one of the most common causes of ill health and morbidity in the older population. In Sweden about 300 000 people/year seek emergency treatment due to falls and out of these 1600 dies. Poor balance control leads to a sedentary life with muscle weakness, fear of falling and an increased risk for falls. Balance training and physical activity have positive effects on fall prevention and balance, but long-term follow-ups are limited. There is also a gap between what has been proven to be efficient in research and what is performed in communities and clinical settings.

Many studies reports on the efficacy of certain treatment, method or training program, which often may have taken years to develop, but few of these results are taken further into clinical practice and it may take years for them to come into daily use. This delay means that there is a gap between what is known and what is consistently done. It if of importance implement methods that have been proven to have beneficial impact on health and physical function in a clinical trial. Furthermore to evaluate which strategies for implementation that are of significance. The aim of this study is to implement evidence based balance training into clinical practice to prevent future falls and fall-related injuries in older adults.

The program has been proven to be efficient, but not yet been implemented in the community and clinical settings. Implementation outcomes will include effectiveness, acceptability, feasibility, fidelity, cost and sustainability. Outcome variables on individual level will be fall-related concerns, balance performance, physical function and activity, health related quality of life and number of falls.

The investigators foresee that this balance training for older adults will prevent future falls and fall related injuries, increase physical activity level, health related quality of life and provide the participants with a strategy to be able to have a physically active and healthy life style.

详细描述

This project is a cluster-randomized study comparing different implementation strategies. The study will comprise clinical settings in primary health care (PHC) and in senior residential care.

Participating clinics will be recruited strategically with regard to catchment area and population structure, to achieve such a large diverse participation as possible.

Participant to the balance training will be recruited through the participating clinics, from primary care facilities in the vicinity of the clinics involved and by advertisement in local papers in the communities. Participants reporting their interest to partake in the study will be telephone-interview and informed about the project and checked for eligibility. Thereafter, they will be called to baseline testing.

The investigators plan to involve 30 different PHC and thereby 360-480 participants in balance training (two groups with 6-8 participants per semester from each clinic during 2 semesters).

In two previous randomised controlled studies performed by the research group in Stockholm county regarding group balance-training for older adults at risk of falling the investigators received a large number of people reporting interest by announcement, i.e. approximately 500 subjects. However, most of them were excluded because they had not a verified diagnosis of osteoporosis, which was one of the inclusion criteria's in those two studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • 65 years or older, independent ambulatory indoors, self-perceived balance problems and/or fear of falling.

排除标准

  • Had fall-related fractures during the last six months,
  • Severely decreased vision, or other diseases or constrains that might interfere with participation in the training program.

结局指标

主要结局

Sustainability of the balance training programme in clinical setting

时间窗: Sustainability will be assessed during a period of 18 months

Sustainability will be assessed using both quantitative and qualitative methods and include measures on compliance/fidelity to the training program. A successful implementation will be consider if the clinic has contained/sustained the balance training during 18 months

次要结局

未报告次要终点

研究者

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

Alexandra Halvarsson

medicine doctor

Karolinska Institutet

研究点 (1)

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