Clinical trial NCT05377801: Chinese Version of LIVE-LiFE for Older Adults With Previous Falls
Official title: Multifaceted Fall Prevention Program for Chinese Community-dwelling Older Adults With Fall Risks: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Falls
Lead sponsor: Sigma Theta Tau International
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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。

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

* 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.

Primary outcomes:
measure: Physical Functioning:1.（short physical performance battery, SPPB）
timeFrame: Three months
measure: Physical Functioning:2. (timed get up and go test/the timed up and go test, TUG)
timeFrame: Three months
Secondary outcomes:
measure: 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))
timeFrame: Three months
measure: Quality of life was measured using the Chinese version of the five EuroQol questionnaire (EQ-5D)
timeFrame: Three months
measure: Cognitive function and mental status are adopted: Mini-cog Test, Patient health questionnaire (PHQ-9).
timeFrame: Three months
measure: 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)
timeFrame: Three months
measure: Taking medications and dietary supplements uses the Beliefs About Medical Questionnaire (BMQ)
timeFrame: Three months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Minhui Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: