FallNCT04702828
The Influence Of Physiological And Psychological Factors On Fall Syndrome
An observational study of Fall, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Most of previous studies are cross-sectional studies, and rarely explore the changes in physical activity, mental state, cognitive and motor functions over time after a fall. Therefore, we hope to find out what changes in the elders' physiological and psychological functions after a fall. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Mar 2020to 2 Mar 2021
- Phase
- Observational
- 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 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Older participants with a history of fall within 2 months will be recruited from the emergency department in a regional hospital and older participants without a history of fall in the past year will be recruited from the community daycare centers.
Who may be able to join
- 1.60 years to 99 years old 2.Fall experiences within two months 3.Can understand and answer the questions 4.Can give their informed consent
Who cannot join
- 1.Serious fracture or head trauma caused by a fall, 2.Unable to perform a walking test, 3. Neurological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fall Syndrome: The Influence Of Physiological And Psychological Factors On Behavior After Falls Principal Investigator
Most of previous studies are cross-sectional studies, and rarely explore the changes in physical activity, mental state, cognitive and motor functions over time after a fall. Therefore, we hope to find out what changes in the elders' physiological and psychological functions after a fall.
Read the detailed description
Falls are the main cause of accidental injuries that are common among the elderly. In Taiwan, the incidence of falls is about 15% to 34%. Falling can cause subsequent serious injuries and post-fall syndromes. Post-fall syndrome is common after a fall. The symptoms of self-restricted activity for fear of falling again affect about one-fifth of older fallers. This syndrome develops within a short period of time after a fall, which not only causes serious problems but also affects psychological symptoms and dependence on daily life functions. All of these reduce the function of movement and increase the chance of falling again. However, most of the past studies are cross-sectional studies, and rarely explore the changes in physical activity, mental state, cognitive and motor functions over time after a fall. Therefore, the study will investigate the changes in physiological and psychological functions after a fall among older adults who experiences a recent fall within 2 months. Additionally, the physiological and psychological functions will be compared between older adults with and without a history of falls.
- Conditions
- Fall
- Keywords
- Fall Syndrome, elderly,Physiological,Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fallers group | 1.60 years to 99 years old 2. have a recent fall within two months 3.can understand and answer the questions 4.can give their informed consent | |
| Non-fallers group | 1.60 years to 99 years old 2. have any fall experiences in past year 3.can understand and answer the question 4.can give their informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Vision acuity will be measured by the Snellen Chart. The Snellen chart is printed with eleven lines of block letters. The first line consists of one very large E letter. Subsequent rows have increasing numbers of letters with decrease in size. Participant will take the test by covering one eye from 6 meters away, and read aloud the letters of each row, beginning at the top. The smallest row that can be read accurately indicates the visual acuity in that specific eye.
Measured: Baseline
Vertigo symptom
Situational Vertigo Questionnaire (SVQ) consists of 19 questions, with a score from 0 (not at all), 1 (very slightly), 2 (somewhat), 3 (quite a lot) to 4 (very much). It measures how frequently symptoms (unusual disorientation, dizziness, giddiness, light-headedness or unsteadiness) are provoked or exacerbated in environments with visual-vestibular conflict or intense visual motion e.g. busy supermarket aisles. A score is obtained by dividing the total sum for activities experienced by the number of activities.
Measured: Baseline
Medication history
Medication history will be recorded including drug name, dose, route, and frequency.
Measured: Baseline
Static balance
Static balance test will be assessed by the modified Clinical Test for Sensory Interaction in Balance(mCTSIB), The mCTSIB was developed as a clinical version of the Sensory Organization Test and was developed to assess sensory contributions to postural control.
Participants will stand with their hands at their sides, feet together and perform the following 4 sensory conditions: (1) Stand on firm surface, eyes open (2) Stand on firm surface, eyes closed (3) Stand on foam surface, eyes open (4) Stand on foam surface, eyes closed. Each condition will be timed for maximum 30 seconds. The test is terminated when a participant's arms or feet move. If a participant is unable to maintain the position for 30 seconds they are provided with 2 additional attempts. The time (s) to complete each condition will be recorded.
Measured: Baseline
Dynamic balance
Dynamic balance test will be evaluated by the functional reach test. The participant will be instructed to stand next to a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion. The assessor instructs the participant to "Reach as far as you can forward without taking a step." The distance (cm) from the start to end position at the middle fingertip will be measured.
Measured: Baseline
Walking ability
Walking ability test will be measured by the 10 meter walk test. Participant will be asked to walk on a 14 meters walkway at their comfortable speed. The time for the middle 10 meters will be recorded and walking speed (m/s) will be calculated.
Measured: Baseline
Hand grip
Dominant hand grip (kg) will measured by a dynamometer. Participants will stand with their arms down by their sides. They will squeeze the dynamometer with maximum isometric effort, which is maintained for 6 seconds.
Measured: Baseline
Lower limbs strength
Lower limbs strength will be assessed by the Five Times Sit to Stand. Participants will be asked to sit on the chair with arms folded across their chest, and stand up and sit down as quickly as possible for 5 times. The time (s) to complete the task will be recorded.
Measured: Baseline
Function ability
Function ability test will be determined by the timed up and go test (TUG). Participants will be asked to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The time (s) to complete the task will be recorded.
Measured: Baseline
Cognitive function (mild cognitive impairment)
Cognitive function will be evaluated by the Montreal Cognitive Assessment (MoCA), which covers visuospatial abilities, short-term memory recall task, multiple aspects of executive functions, attention, concentration, and working memory. The total score is 30 and cut-off point is 26. Score less than 26 indicates mild cognitive impairment.
Measured: Baseline
Cognitive function (dementia)
Mini-Mental State Examination(MMSE) is used extensively in clinical and research settings to measure cognitive impairment, covering attention, calculation, recall, language, ability to follow simple commands and orientation. It is commonly used in medicine and allied health to screen for dementia; used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment.
Measured: Baseline
Fear of falling
Fear of falling will be measured by the Falls Efficacy Scale International(FES). The FES rated each daily task from no confident at all to completely confident. The total score between 16 and 64, and the score more than 28 indicates higher level of fear of falling.
Measured: Baseline
The confidence of balance
The confidence of balance will test by Activities-specific Balance and Confidence (ABC) Scale. The ABC Scale is a 16-item questionnaire. Each item is rated from 0% (no confidence) to 100% (complete confidence) by all participants. The higher score, the more confidence they have.
Measured: Baseline
Depression Anxiety and Stress
Depression, anxiety and stress will be assessed by the Depression Anxiety and Stress(DASS-21). It is a self-reported scale designed to measure the negative emotional states of depression, anxiety and stress. The higher score indicates the increased severity of symptoms.
Measured: Baseline
Sarcopenia
Sarcopenia will be screened by the SARC-F including how much difficulty do you have in lifting and carrying 10 pounds, how much difficulty do you have walking cross a room, how much difficulty do you have transferring from a chair or bed, how much difficulty do you have climbing a flight of 10 stairs, and how many times have you fallen in the past year. The score more than 4 indicates high risk of sarcopenia.
Measured: Baseline
Frailty
Frailty will be assessed by the Fried frailty phenotype. It is a yes-no model based on five items including physical inactivity, low muscle strength, slow gait speed, exhaustion/ fatigue and weight loss. Each item is scored as 0 (no) or 1 (yes). The score of greater than 3 indicates frailty.
Measured: Baseline
Basic Activity of Daily Living
Basic activities of daily living will be measured by the Barthel Index. It is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge. Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL. The score of 0-20 indicates "total" dependency, 21-60 indicates "severe" dependency, 61-90 indicates "moderate" dependency, and 91-99 indicates "slight" dependency.
Measured: Baseline
Instrumental Activity of Daily Living
Instrumental activities of daily living (IADL) will be measured by the Lawton Instrumental Activities of Daily Living Scale which assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finances. It contains eight items, with a summary score from 0 (low function) to 8 (high function).
Measured: Baseline
Health-related quality of life
The quality of life will be assessed by the Control, Autonomy, Self-Realization and Pleasure (CASP-19), which has 4 subscales and 19 items in total. A 4-point Likert scale is used including "often", "sometimes", "not often" and "never". The higher score indicates the better quality of life.
Measured: Baseline
Physical Activity
Physical Activity will be examined by the International Physical Activity Questionnaire (IPAQ)-Short Form. Participants will be asked about their duration (in minutes) and frequency (days) when performing four specific types of activity: walking, moderate intensity, vigorous intensity and sitting.
Measured: Baseline
Social function survey
Participants will be asked whether they have been in contact with family or friends in the past six months. According to the scale of different networks, the frequency of interaction and the degree of closeness, interpersonal relationships and social support networks can be determined.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start3 Mar 2020
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Chun Lee, Taipei Medical University
- Investigators
- Shu-Chun Lee, PhD, Principal investigator, School of Gerontology Health Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702828
- Sponsor's protocol ID
- N202002009
- Status last verified
- Mar 2021
- First submitted
- 7 Jan 2021
- Last updated
- 1 Apr 2021
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Syndrome: The Influence Of Physiological And Psychological Factors On Behavior After Falls Principal Investigator
- ClinicalTrials.gov ID
- NCT04702828
- Acronym / sponsor ID
- N202002009
- Conditions
- Fall
- Keywords
- Fall Syndrome, elderly,Physiological,Psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 11 Jan 2021 (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.
Most of previous studies are cross-sectional studies, and rarely explore the changes in physical activity, mental state, cognitive and motor functions over time after a fall. Therefore, we hope to find out what changes in the elders' physiological and psychological functions after a fall.
Detailed description
Falls are the main cause of accidental injuries that are common among the elderly. In Taiwan, the incidence of falls is about 15% to 34%. Falling can cause subsequent serious injuries and post-fall syndromes. Post-fall syndrome is common after a fall. The symptoms of self-restricted activity for fear of falling again affect about one-fifth of older fallers. This syndrome develops within a short period of time after a fall, which not only causes serious problems but also affects psychological symptoms and dependence on daily life functions. All of these reduce the function of movement and increase the chance of falling again. However, most of the past studies are cross-sectional studies, and rarely explore the changes in physical activity, mental state, cognitive and motor functions over time after a fall. Therefore, the study will investigate the changes in physiological and psychological functions after a fall among older adults who experiences a recent fall within 2 months. Additionally, the physiological and psychological functions will be compared between older adults with and without a history of falls.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fallers group | – | –1.60 years to 99 years old 2. have a recent fall within two months 3.can understand and answer the questions 4.can give their informed consent |
| Non-fallers group | – | –1.60 years to 99 years old 2. have any fall experiences in past year 3.can understand and answer the question 4.can give their informed consent |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older participants with a history of fall within 2 months will be recruited from the emergency department in a regional hospital and older participants without a history of fall in the past year will be recruited from the community daycare centers.
Key inclusion criteria (1 listed)
- 1.60 years to 99 years old 2.Fall experiences within two months 3.Can understand and answer the questions 4.Can give their informed consent
Key exclusion criteria (1 listed)
- 1.Serious fracture or head trauma caused by a fall, 2.Unable to perform a walking test, 3. Neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual acuity
Time frame: Baseline
Vision acuity will be measured by the Snellen Chart. The Snellen chart is printed with eleven lines of block letters. The first line consists of one very large E letter. Subsequent rows have increasing numbers of letters with decrease in size. Participant will take the test by covering one eye from 6 meters away, and read aloud the letters of each row, beginning at the top. The smallest row that can be read accurately indicates the visual acuity in that specific eye.
Vertigo symptom
Time frame: Baseline
Situational Vertigo Questionnaire (SVQ) consists of 19 questions, with a score from 0 (not at all), 1 (very slightly), 2 (somewhat), 3 (quite a lot) to 4 (very much). It measures how frequently symptoms (unusual disorientation, dizziness, giddiness, light-headedness or unsteadiness) are provoked or exacerbated in environments with visual-vestibular conflict or intense visual motion e.g. busy supermarket aisles. A score is obtained by dividing the total sum for activities experienced by the number of activities.
Medication history
Time frame: Baseline
Medication history will be recorded including drug name, dose, route, and frequency.
Static balance
Time frame: Baseline
Static balance test will be assessed by the modified Clinical Test for Sensory Interaction in Balance(mCTSIB), The mCTSIB was developed as a clinical version of the Sensory Organization Test and was developed to assess sensory contributions to postural control. Participants will stand with their hands at their sides, feet together and perform the following 4 sensory conditions: (1) Stand on firm surface, eyes open (2) Stand on firm surface, eyes closed (3) Stand on foam surface, eyes open (4) Stand on foam surface, eyes closed. Each condition will be timed for maximum 30 seconds. The test is terminated when a participant's arms or feet move. If a participant is unable to maintain the position for 30 seconds they are provided with 2 additional attempts. The time (s) to complete each condition will be recorded.
Dynamic balance
Time frame: Baseline
Dynamic balance test will be evaluated by the functional reach test. The participant will be instructed to stand next to a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion. The assessor instructs the participant to "Reach as far as you can forward without taking a step." The distance (cm) from the start to end position at the middle fingertip will be measured.
Walking ability
Time frame: Baseline
Walking ability test will be measured by the 10 meter walk test. Participant will be asked to walk on a 14 meters walkway at their comfortable speed. The time for the middle 10 meters will be recorded and walking speed (m/s) will be calculated.
Hand grip
Time frame: Baseline
Dominant hand grip (kg) will measured by a dynamometer. Participants will stand with their arms down by their sides. They will squeeze the dynamometer with maximum isometric effort, which is maintained for 6 seconds.
Lower limbs strength
Time frame: Baseline
Lower limbs strength will be assessed by the Five Times Sit to Stand. Participants will be asked to sit on the chair with arms folded across their chest, and stand up and sit down as quickly as possible for 5 times. The time (s) to complete the task will be recorded.
Function ability
Time frame: Baseline
Function ability test will be determined by the timed up and go test (TUG). Participants will be asked to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The time (s) to complete the task will be recorded.
Cognitive function (mild cognitive impairment)
Time frame: Baseline
Cognitive function will be evaluated by the Montreal Cognitive Assessment (MoCA), which covers visuospatial abilities, short-term memory recall task, multiple aspects of executive functions, attention, concentration, and working memory. The total score is 30 and cut-off point is 26. Score less than 26 indicates mild cognitive impairment.
Cognitive function (dementia)
Time frame: Baseline
Mini-Mental State Examination(MMSE) is used extensively in clinical and research settings to measure cognitive impairment, covering attention, calculation, recall, language, ability to follow simple commands and orientation. It is commonly used in medicine and allied health to screen for dementia; used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment.
Fear of falling
Time frame: Baseline
Fear of falling will be measured by the Falls Efficacy Scale International(FES). The FES rated each daily task from no confident at all to completely confident. The total score between 16 and 64, and the score more than 28 indicates higher level of fear of falling.
The confidence of balance
Time frame: Baseline
The confidence of balance will test by Activities-specific Balance and Confidence (ABC) Scale. The ABC Scale is a 16-item questionnaire. Each item is rated from 0% (no confidence) to 100% (complete confidence) by all participants. The higher score, the more confidence they have.
Depression Anxiety and Stress
Time frame: Baseline
Depression, anxiety and stress will be assessed by the Depression Anxiety and Stress(DASS-21). It is a self-reported scale designed to measure the negative emotional states of depression, anxiety and stress. The higher score indicates the increased severity of symptoms.
Sarcopenia
Time frame: Baseline
Sarcopenia will be screened by the SARC-F including how much difficulty do you have in lifting and carrying 10 pounds, how much difficulty do you have walking cross a room, how much difficulty do you have transferring from a chair or bed, how much difficulty do you have climbing a flight of 10 stairs, and how many times have you fallen in the past year. The score more than 4 indicates high risk of sarcopenia.
Frailty
Time frame: Baseline
Frailty will be assessed by the Fried frailty phenotype. It is a yes-no model based on five items including physical inactivity, low muscle strength, slow gait speed, exhaustion/ fatigue and weight loss. Each item is scored as 0 (no) or 1 (yes). The score of greater than 3 indicates frailty.
Basic Activity of Daily Living
Time frame: Baseline
Basic activities of daily living will be measured by the Barthel Index. It is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge. Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL. The score of 0-20 indicates "total" dependency, 21-60 indicates "severe" dependency, 61-90 indicates "moderate" dependency, and 91-99 indicates "slight" dependency.
Instrumental Activity of Daily Living
Time frame: Baseline
Instrumental activities of daily living (IADL) will be measured by the Lawton Instrumental Activities of Daily Living Scale which assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finances. It contains eight items, with a summary score from 0 (low function) to 8 (high function).
Health-related quality of life
Time frame: Baseline
The quality of life will be assessed by the Control, Autonomy, Self-Realization and Pleasure (CASP-19), which has 4 subscales and 19 items in total. A 4-point Likert scale is used including "often", "sometimes", "not often" and "never". The higher score indicates the better quality of life.
Physical Activity
Time frame: Baseline
Physical Activity will be examined by the International Physical Activity Questionnaire (IPAQ)-Short Form. Participants will be asked about their duration (in minutes) and frequency (days) when performing four specific types of activity: walking, moderate intensity, vigorous intensity and sitting.
Social function survey
Time frame: Baseline
Participants will be asked whether they have been in contact with family or friends in the past six months. According to the scale of different networks, the frequency of interaction and the degree of closeness, interpersonal relationships and social support networks can be determined.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
Shu-Chun Lee, PhD principal investigator
School of Gerontology Health Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fall, run by Taipei Medical University at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Apr 2021. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Baseline). The study lists 21 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 1 Apr 2021.