FallersNCT03839563
Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults
A study testing Exercise in people with Fallers and Mild Cognitive Impairment, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Fallers, Mild Cognitive Impairment
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2019to 31 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- At least 65 years old
- Had an emergency department visit due to a fall at least 3 months prior to the baseline assessment (assuming a full recovery time from a fall to be 3 months)
- Can ambulate independently
- Has mild cognitive impairment
Who cannot join
- Do not live in a community setting
- Cannot ambulate independently and communicate with researchers
- Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
- Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University
Taipei, 110
Chih-Yi Chen, Master, 886-2-27361661 ext. 6572, m513090003@tmu.edu.tw
About this study
The effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. Third, whether changes in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the intervention will be examined.
- Conditions
- Fallers, Mild Cognitive Impairment
- Being tested
- Exercise
- Keywords
- Biomarker, Cognitive impairment, Gait abnormality, Older Adults, Exercise
- Medical subject headings
- Cognitive Dysfunction, Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
| Study group | Role | What they receive |
|---|---|---|
| Conventional exercise | Experimental | This exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months. Each session will last 60 min. Receives: Behavioral: Exercise |
| Tai chi chuan | Experimental | The 8-form Yang-style tai chi chuan intervention will take place at a subject's residence or in the neighborhood once a week for 6 months, and each session will last 60 min. Receives: Behavioral: Exercise |
| Health education/usual physical activity | No intervention | After the baseline, the case manager will visit subjects in this group once for comparability with the other two intervention groups and instruct them to maintain their usual physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait characteristics
Performance on six gait characteristics (velocity, cadence, stride length, swing time, stride length variability, and swing time variability) will be measured with a 6-m electronic walkway of GAITRite.
Measured: 12 months
Global cognition
Global cognition will be assessed using the Mini-Mental State Examination (MMSE). The MMSE comprises 11 questions, and the score ranges 0~30, with lower scores indicating poorer global cognition.
Measured: 12 months
Serum levels of BDNF
Serum BDNF concentrations will be assessed.
Measured: 12 months
Serum levels of IGF-1
Serum IGF-1 concentrations will be assessed.
Measured: 12 months
Serum levels of VEGF
Serum VEGF concentrations will be assessed.
Measured: 12 months
Secondary outcomes (6)
Tinetti balance
The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
Measured: 12 months
Mobility
The timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.
Measured: 12 months
Muscle strength
Grip strength will be assessed via a handgrip dynamometer and measured in kilograms of isometric force.
Measured: 12 months
Falls
number of falls and multiple falls
Measured: 12 months
Depressive symptoms
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS).
Measured: 12 months
Fear of falling
Fear of falling will be assessed using the Falls Efficacy Scale (FES) test.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start15 Feb 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic, single-blinded, randomized controlled trial with three arms will be conducted to investigate the effectiveness of conventional exercise and tai chi chuan, compared to health education/usual physical activity.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Mau-Roung Lin, Professor, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839563
- Sponsor's protocol ID
- NHRI-EX108-10804PI
- Status last verified
- Sep 2022
- First submitted
- 31 Jan 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults
- ClinicalTrials.gov ID
- NCT03839563
- Acronym / sponsor ID
- NHRI-EX108-10804PI
- Conditions
- Fallers, Mild Cognitive Impairment
- Keywords
- Biomarker, Cognitive impairment, Gait abnormality, Older Adults, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Feb 2019 (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 effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. Third, whether changes in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the intervention will be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A pragmatic, single-blinded, randomized controlled trial with three arms will be conducted to investigate the effectiveness of conventional exercise and tai chi chuan, compared to health education/usual physical activity.
| Arm | Type | Receives |
|---|---|---|
| Conventional exercise | Experimental | Behavioral: ExerciseThis exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months. Each session will last 60 min. |
| Tai chi chuan | Experimental | Behavioral: ExerciseThe 8-form Yang-style tai chi chuan intervention will take place at a subject's residence or in the neighborhood once a week for 6 months, and each session will last 60 min. |
| Health education/usual physical activity | No intervention | –After the baseline, the case manager will visit subjects in this group once for comparability with the other two intervention groups and instruct them to maintain their usual physical activity. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- At least 65 years old
- Had an emergency department visit due to a fall at least 3 months prior to the baseline assessment (assuming a full recovery time from a fall to be 3 months)
- Can ambulate independently
- Has mild cognitive impairment
Key exclusion criteria (4 listed)
- Do not live in a community setting
- Cannot ambulate independently and communicate with researchers
- Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
- Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)
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 |
|---|---|---|
| ExerciseEach session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down. | Behavioural | Conventional exercise, Tai chi chuan |
Primary outcome
Gait characteristics
Time frame: 12 months
Performance on six gait characteristics (velocity, cadence, stride length, swing time, stride length variability, and swing time variability) will be measured with a 6-m electronic walkway of GAITRite.
Global cognition
Time frame: 12 months
Global cognition will be assessed using the Mini-Mental State Examination (MMSE). The MMSE comprises 11 questions, and the score ranges 0~30, with lower scores indicating poorer global cognition.
Serum levels of BDNF
Time frame: 12 months
Serum BDNF concentrations will be assessed.
Serum levels of IGF-1
Time frame: 12 months
Serum IGF-1 concentrations will be assessed.
Serum levels of VEGF
Time frame: 12 months
Serum VEGF concentrations will be assessed.
6 secondary outcomes
Tinetti balance
Time frame: 12 months
Mobility
Time frame: 12 months
Muscle strength
Time frame: 12 months
Falls
Time frame: 12 months
Depressive symptoms
Time frame: 12 months
Fear of falling
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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Changes in Spatiotemporal Gait Parameters During a Digitally Assisted Self-rehabilitation Program for Elderly Fallers ( DigiWalk )
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Follow-up of Elderly Subjects With Falls Recruited in the Geriatric Departments of Several French Hospitals
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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.
Mau-Roung Lin, Professor principal investigator
Taipei Medical 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 Exercise in people with Fallers and Mild Cognitive Impairment, 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 4 inclusion and 4 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 29 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mau-Roung Lin, Professor (886-2-27361661 ext. 6572, mrlin@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait characteristics (time frame: 12 months). The study lists 5 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 29 Sep 2022.