跳至主要内容
临床试验/NCT05377801
NCT05377801Unknown不适用

Multifaceted Fall Prevention Program for Chinese Community-dwelling Older Adults With Fall Risks: A Pilot Randomized Controlled Trial

Sigma Theta Tau International1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
Physical Functioning:1.(short physical performance battery, SPPB)

研究概览

简要总结

The research is to solve the problem of the high incidence of falls among older adults in China. To this end, the investigators will develop a multi-dimensional fall prevention program by cultivating nursing students as community intervention personnel to address the current shortage of fall prevention programs and professional intervention in China. The research will make an important contribution to health care.

详细描述

The study intervention group is a 12-week multi-dimensional intervention, consisting of four parts: individualized balance and strength training, vision screening, drug evaluation, home risk assessment and home repair and transformation. Interventors will teach skills related to balance and strength training, incorporate these principles and exercises into daily and leisure activities, and how to increase the challenge of balance. The one-hour home visit aims to develop a personalized plan for participants by understanding each participant's health, exercise preferences, sedentary behaviors, and identifying needs related to the risk of falling. In particular, the interventionist will work with the participant to determine 6 skills or activities, and the participant hopes to practice ankle weight bearing at least 3 times a week based on their interests and abilities. Interventions and participants will work together to develop personal goals and plans, using exercise logs for gradual exercise, to continuously increase strength, resistance, weight, and challenge balance or strength. During home visits, the intervener will also assess participants' inherent risks by assessing their visual acuity, assess their home risk factors, and discuss with their caregiver or their children what risks would arise if the elderly live alone. In addition to group meetings and home visits, the interventionists will call to ask about progress and provide support and encouragement. Participants in the control group will receive the same amount of health education。

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
是

入选标准

  • •age ≥60 years;
  • •Falls ≥2 times or injuries caused by falls ≥ 1times in the past year;

排除标准

  • •residents who cannot live in a community in Changsha for more than 3 months, or who reside in a long-term care institution in Changsha;
  • •Moderate to severe cognitive impairment based on a simple and portable mental state questionnaire;
  • •Unable to walk independently;
  • •Has the nervous system condition which seriously affects its gait and activity;
  • •Any unstable or terminal illness that may interfere with planned exercise and is unlikely to be resolved;
  • •He is currently undergoing physical therapy.

研究组 & 干预措施

The intervention group

Experimental

The intervention group of this study is a multi-dimensional intervention conducted by nursing students over a 12-week period, consisting of four parts: individualized balance and strength training, vision screening, drug evaluation, home risk assessment and home repair and transformation. These components were carried out through a combination of personal home visits and telephone interviews.

干预措施: Multi-dimensional fall prevention intervention program for 12 weeks (Behavioral)

The control group

No Intervention

The control group would receive the same amount of health education.

结局指标

主要结局

Physical Functioning:1.(short physical performance battery, SPPB)

时间窗: Three months

SPPB is used to evaluate the comprehensive functions of lower limb muscle strength, balance, and walking, including 3 parts: 5 sit-ups, standing in series (including two feet standing side by side, one heel and the other side of the big toe standing sideways, one Stand with the heel of one foot close to the top of the big toe of the other foot) and walk 8 feet.

Physical Functioning:2. (timed get up and go test/the timed up and go test, TUG)

时间窗: Three months

2. TUG involves balance in the sitting position, whether the transition from sitting to standing is smooth, walking gait, speed, and stability, and whether hesitant to turn around, etc., and can be used to evaluate the dynamic balance ability and mobility function.

次要结局

  • Living habits and physical activities used: Physical Activity Scale for the Elderly (PASE), Activity of daily living function (ADL), Instrumental Daily Life Activity Ability Scale (IADL)(Three months)
  • Taking medications and dietary supplements uses the Beliefs About Medical Questionnaire (BMQ)(Three months)
  • Fear of falling was assessed by the Fall Efficacy Scale-International Chinese Version (FES-I (Ch)) Fear of falls was assessed by the Fall Efficacy Scale-International Chinese Version (FES-I (Ch))(Three months)
  • Quality of life was measured using the Chinese version of the five EuroQol questionnaire (EQ-5D)(Three months)
  • Cognitive function and mental status are adopted: Mini-cog Test, Patient health questionnaire (PHQ-9).(Three months)

研究者

发起方
Sigma Theta Tau International
申办方类型
Other
责任方
Principal Investigator
主要研究者

Minhui Liu

Associate professor

Central South University

研究点 (1)

Loading locations...

相似试验