Chinese Version of LIVE-LiFE for Older Adults With Previous Falls

NCT05377801 | Unknown

• 1 other identifier: IRB00186421
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Falls

Outcome Measures

Primary Outcomes (2)

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

  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.

  Three months

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

  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.

  Three months

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

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.

Behavioral: Multi-dimensional fall prevention intervention program for 12 weeks

The control group

NO INTERVENTION

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

Interventions

Multi-dimensional fall prevention intervention program for 12 weeks BEHAVIORAL

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.

The intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sigma Theta Tau International: lead

Study Sites (1)

Central South University

Changsha, Hunan, 430100, China

RECRUITING

Study Officials

• Minhui Liu, Ph.D

  Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minhui Liu, Ph.D

CONTACT

+86 133-7894-9466; mliu62@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: May 17, 2022
• Study Start: September 11, 2019
• Primary Completion: December 6, 2023
• Study Completion: December 12, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

CN (1)