Accidental FallsNCT05377801
Chinese Version of LIVE-LiFE for Older Adults With Previous Falls
A study testing Multi-dimensional fall prevention intervention program for 12 weeks in people with Accidental Falls, run by Sigma Theta Tau International at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Multi-dimensional fall prevention intervention program for 12 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2019to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥60 years;
- Falls ≥2 times or injuries caused by falls ≥ 1times in the past year;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Central South University
Changsha, Hunan, 430100
Yuqian Luo, Bachelor, 18175172084, 207811018@csu.edu.cn
About this study
Official title: Multifaceted Fall Prevention Program for Chinese Community-dwelling Older Adults With Fall Risks: A Pilot Randomized Controlled Trial
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.
Read the 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。
- Conditions
- Accidental Falls
- Being tested
- Multi-dimensional fall prevention intervention program for 12 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-dimensional fall prevention intervention program for 12 weeksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
Physical Functioning:2. (timed get up and go test/the timed up and go test, TUG)
- 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.
Measured: 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))
FES-I (Ch) measures the degree of anxiety about falls among participants during 16 activities. The total score ranges from 16-64 points, a higher total score indicates a greater sense of fall efficacy. The original FES-I and FES-I (Ch) have good reliability (Cronbach's alpha: 0.96 ~ 0.97) and have structural validity in different studies.
Measured: Three months
Quality of life was measured using the Chinese version of the five EuroQol questionnaire (EQ-5D)
Participants will be asked if they have no problems in five dimensions, some or moderate questions, including actions, self-care, daily activities, pain / discomfort, anxiety / depression. The total score ranges from 0 to 100 points, higher scores mean a better quality of life.
Measured: Three months
Cognitive function and mental status are adopted: Mini-cog Test, Patient health questionnaire (PHQ-9).
(1) Mini-cog Test, which can be completed in 3 minutes, and is mostly used to distinguish whether or not they have dementia. The total score ranges 1 to 3, higher scores mean a better cognitive status. The scale has a sensitivity of 76% ～ 99%, specificity is 89% -93%, and has a good predictive value of dementia for the participants. (2) Patient health questionnaire (PHQ-9). This scale is used to understand how much time participants have been affected by 9 questions including depression and interest in the past two weeks. The total score ranges from 0 to 27, higher scores mean a worse depressive status. The researchers Summarized (PHQ-9) that the Cronbach's alpha used in the community elderly population was 0.832, the sensitivity was 88%, and the specificity was 99% 49.
Measured: 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)
(1) Physical Activity Scale for the Elderly (PASE). The scale consists of 10 major categories of problems, including physical exercise, housework, and occupational physical activity. The total score range from 0 to 400, higher scores mean a better physical activity. (2) Activity of daily living function (ADL), which includes two parts: Physical Self-Maintenance Scale (PSMS; 6 items) and instrumental ability of daily living Scale (Instrumental Activity of Daily Living IADL; 8). Each entry is graded on a scale of 1 to 4. The total score ranges from 0 to 100, higher scores mean a worse ability of daily activity. (3) Instrumental Daily Life Activity Ability Scale (IADL): Includes recreation and leisure, use of transportation, cooking, housework maintenance, telephone use, medication, and financial management. The total score ranges from 0 to 56, higher scores mean a worse ability of instrumental daily activity.
Measured: Three months
Taking medications and dietary supplements uses the Beliefs About Medical Questionnaire (BMQ)
Medical Questionnaire (BMQ), which includes two sub-scales: the patient's general belief in any drug (BMQ-General) and specificity for a certain class of drugs Belief (BMQ-Specific). The researchers experimentally obtained the Cronbach's alpha coefficients of the two dimensions of the Chinese version of BMQ medication necessity and medication concern in elderly patients with depression; the retest reliability was 0.743 and 0.786, respectively; Degree coefficient (CVI) is 0.80 ~ 1.00
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start11 Sep 2019
- Primary completion6 Dec 2023 (estimated)
- Study completion12 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sigma Theta Tau International
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minhui Liu, Central South University
- Investigators
- Minhui Liu, Ph.D, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377801
- Sponsor's protocol ID
- IRB00186421
- Status last verified
- May 2022
- First submitted
- 16 Dec 2021
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifaceted Fall Prevention Program for Chinese Community-dwelling Older Adults With Fall Risks: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05377801
- Acronym / sponsor ID
- IRB00186421
- Conditions
- Accidental Falls
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sigma Theta Tau InternationalUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 6 Dec 2023 (estimated)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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。
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: Multi-dimensional fall prevention intervention program for 12 weeksThe 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 control group | No intervention | –The control group would receive the same amount of health education. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥60 years;
- Falls ≥2 times or injuries caused by falls ≥ 1times in the past year;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-dimensional fall prevention intervention program for 12 weeksThe 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. | Behavioural | The intervention group |
Primary outcome
Physical Functioning:1.（short physical performance battery, SPPB）
Time frame: 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)
Time frame: 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.
5 secondary outcomes
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))
Time frame: Three months
Quality of life was measured using the Chinese version of the five EuroQol questionnaire (EQ-5D)
Time frame: Three months
Cognitive function and mental status are adopted: Mini-cog Test, Patient health questionnaire (PHQ-9).
Time frame: 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)
Time frame: Three months
Taking medications and dietary supplements uses the Beliefs About Medical Questionnaire (BMQ)
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minhui Liu, Ph.D principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-dimensional fall prevention intervention program for 12 weeks in people with Accidental Falls, run by Sigma Theta Tau International at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minhui Liu, Ph.D (+86 133-7894-9466, mliu62@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Functioning:1.（short physical performance battery, SPPB） (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.