Pre-frail ElderlyNCT04605809
Effects of Combined Motor and Cognitive Training in Pre-frail Elderly
A study testing combined motor and cognitive training, motor training alone and cognitive training alone in people with Pre-frail Elderly, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of combined motor and cognitive training on physical fitness, brain fitness, and dual-task walking performance in pre-frail elderly. Specifically, we will investigate psychometric properties (i.e. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-frail Elderly
- What is being tested?
- combined motor and cognitive training, motor training alone and cognitive training alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2021to 31 Jul 2024
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age more than 65 years old
- fit one of the criteria for pre-frail definition: (1) body weight lost more than 3 kg or 5% as compared to last year; (2) unable to compete 5 times of Sit to Stand test within 15 seconds; (3 ) more than 3 days fatigue feeling or lack of motivation doing things.
- able to walk 10 meters
- no severe vision, hearing, cognition, and language problems.
- understand instruction (MoCA score>26)
Who cannot join
- neurological or musculoskeletal diagnosis that affects walking
- cognitive impairment (MoCA<26)
- unable to stand for at least 2 minutes
- moderate to severe high blood pressure (systolic blood pressure more than 160 mmHg and diastolic blood pressure more than 100 mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combined Motor and Cognitive Training on Physical Fitness and Brain Fitness in Pre-frail Elderly
The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of combined motor and cognitive training on physical fitness, brain fitness, and dual-task walking performance in pre-frail elderly. Specifically, we will investigate psychometric properties (i.e. reliability and validity) of dual-task walking assessments for pre-frail elderly (Aim 1). The second aim of this study is to compare the effects of combined motor and cognitive training vs. motor training alone vs. cognitive training alone vs. no intervention control on physical fitness, brain fitness, and dual-task walking performance in pre-frail elderly (Aim 2). The third aim of this study is to elucidate the effects of combined motor and cognitive training on patterns of cognitive motor interference in pre-frail elderly (Aim 3).
Read the detailed description
A metric analysis and comparative efficacy research will be conducted. Eighty-four pre-frail elderly will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the dual-task walking assessments will include walking at preferred speed and fast speed and simultaneously perform serial three subtractions and the Stroop task. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest), dual-task Timed-up-and-Go test (dual-TUG), and 6-min walk test obtain concurrently for assessing dual-task ability. A comparative efficacy research is a single-blind, randomized controlled trial, which will be conducted at medical centers. Pre-frail elderly will be randomized to combined motor and cognitive training, motor training alone, cognitive training alone, or no intervention control group. All three training groups will receive interventions 3 times a week for 4 weeks. The combined motor and cognitive training group will undertake physical fitness training under sitting and standing, walking training while sequentially or simultaneously perform cognitive training. The motor training alone group will train the same set of physical fitness training while sitting, standing, and walking as the combined motor and cognitive training group. The cognitive training alone group will train the same set of cognitive training while sitting as the combined motor and cognitive training group. No intervention control group will maintain habit and daily activity. A blinded assessor will administer three assessments. All participants will be examined physical fitness and brain fitness at baseline twice, and post intervention. The primary outcome measures will be components of physical fitness (cardiopulmonary fitness, muscle fitness, flexibility, body composition, and balance)and brain fitness (information processing speed, working memory, response inhibition, spatial memory, and selective attention). The secondary outcome measures will be gait and cognitive performance under dual-task conditions, dual-Timed Up and Go test, the Mini-BESTest, Functional Gait Assessment, and 6-minute Walk Test, Repeated measure ANOVA will be used to compare measurements at baseline and after training among the groups.
- Conditions
- Pre-frail Elderly
- Being tested
- combined motor and cognitive training, motor training alone, cognitive training alone
- Keywords
- pre-frail, physical fitness, brain fitness, dual-task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined motor and cognitive trainingDevice
The combined motor and cognitive training group will receive physical fitness training under sitting and standing, walking training while sequentially or simultaneously perform cognitive training for 45 minutes per session, 3 times a week for 4 weeks.
motor training aloneDevice
The motor training alone group will receive the same set of physical fitness training while sitting, standing, and walking as the combined motor and cognitive training group for 45 minutes per session, 3 times a week for 4 weeks.
cognitive training aloneDevice
The cognitive training alone group will receive the same set of cognitive training while sitting as the combined motor and cognitive training group for 45 minutes per session, 3 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| combined motor and cognitive training | Experimental | The combined motor and cognitive training group will undertake physical fitness training under sitting and standing, walking training while sequentially or simultaneously perform cognitive training. Receives: Device: combined motor and cognitive training |
| motor training alone | Active comparator | The motor training alone group will train the same set of physical fitness training while sitting, standing, and walking as the combined motor and cognitive training group. Receives: Device: motor training alone |
| cognitive training alone | Active comparator | The cognitive training alone group will train the same set of cognitive training while sitting as the combined motor and cognitive training group. Receives: Device: cognitive training alone |
| no intervention control group. | No intervention | No intervention control group will maintain habit and daily activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
weight and height will be combined to report BMI in kg/m^2 measure body composition.
Measured: 1 minute
Waist to hip ratio
waist to hip ratio measure body composition.
Measured: 1 minute
2-Minute Step Test
This test measures aerobic endurance. It requires the subjects march in place as fast as possible for 2 minutes while lifting the knees to a height midway between their patella and iliac crests while standing. The score is the number of right-knee reaches the required height completed in 2 minutes.
Measured: 2 minutes
Chair Stand and Reach Test
This test measures lower body flexibility, especially hamstrings. The subject sits on the edge of a chair (placed against a wall for safety). One foot must remain flat on the floor. The other leg is extended forward with the knee straight, heel on the floot, and ankle bent at 90 degree. Place one hand on the top of the other with tips of the middle fingers even. Instruct the subject to inhale, and then as the exhale, reach forward toward the toes by bending at the hip. Knee the back straight and head up. Avoid bouncing or quick movements, and pain. Keep the knee straight , and hold the reach for 2 seconds. The distance is measured between the tip of the fingertips and the toes. If the fingertips touch toes then the score is zero. If they do not touch, measure the distance between the fingers and the toes as a negative score. If they overlap, measure by how much of the distance as a positive score.
Measured: 1 minutes
Back Scratch Test
This test measures upper body flexibility, especially shoulder movement. This test requires the subject in standing position. Place one hand behind the head and back over the shoulder, and reach as far as possible down the middle of his/her back, his/her psalm touching his/her body and the fingers directed downwards. Place the other arm behind his/her back, palsm facing outward and fingers upward and reach up as far as possible attempting to touch or overlap the middle fingers of both hands. The examiner measures the distance between the tips of the middle fingers. If the fingertips touch, the score is zero. If they do not touch, measure the distance between the fingertips as a negative score. If they overlap, measure by how much of the distance as a positive score.
Measured: 1 minutes
Arm Curl Test
This test measures upper body strength and endurance. The subject sits on a chair, holding the weight in the hand using a suitcase grip (palm facing towards the body) with the arm in a vertically down position beside the chair. Brace the upper arm against the body so that only the lower arm is moving (the examiner assists to hold the upper arm steady). Curl the arm up through a full range of motion, gradually turning the palm up (flexion with supination). As the arm is lowered through the full range of motion, gradually return to the starting position. The arm must be fully bent and then fully straightened at the elbow. Repeat this action as many times as possible within 30 seconds. The score is the numbers of the dominant arm curl within 30 seconds.
Measured: 1 minutes
Chair Stand Test
This test measures leg strength and endurance. The subject is seated in the middle of the chair, back straight, feet approximately a shoulder width apart and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and help against the chest. Have the subject complete as many full stands as possible within 30 seconds. The subject is instructed to fully sit between each stand. The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand).
Measured: 1 minutes
8-Foot Up and Go Test
This test measures mobility, balance, walking ability, and fall risk in older adults. The subject sits in the chair with his/her back against the chair back. On the command" Go" the subject rises from the chair, walk 2.44 meters at a fast and safe speed, turns, walk back to the chair and sit down. Timing begins at the instruction "Go" and stops when the subject is seated.
Measured: 1 minutes
One-leg Standing Test
This test measures static balance control and is performed with eyes open (focus on an object about 3 feet in front of the subject), arms on the hips. The subject must stand unassisted on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg ot an arm leaves the hips.
Measured: 1 minutes
Simple Reaction Time Task (SRT)
It measures information processing speed.In a sitting position, participants will hear a sequential 5 low pitch (500Hz) that are played by a custom-written MatLab program and present stimuli through a wireless headphone. Participants are instructed to respond verbally the pitch of the sound (low) as quickly and as accurately as possible. Before actual measurements, a series of ten auditory stimuli will be practiced. The number of correct responses and reaction time of correct responses provided within testing will be calculated
Measured: 1 minute
Serial three subtraction task
It measures working memory. In this task targeting working memory, participant will be instructed to count backwards by 3s from a two-digit number (eg, subtract 3 from 99 five times as fast as you can). After 2 trials of practice, another 2 trials will be conducted using 2 new number sets. In addition to accuracy and reaction time, the number of correct responses within the given time period of each trial will be calculated.
Measured: 1 minute
Stroop task
It measures response inhibition.The assessment involves showing the participants words written using inks of various colors, and having the participants state the color of the ink. Participants will be asked to name the color with which a color word will be printed, for instance, if the word "blue" is printed in "red" ink, the participant will need to respond "red" to be correct. The words will be displayed on computer screen in front of participants. Participants will be instructed to name colors of a set of words as accurately and as fast as possible. Before actual measurements, a series of five Stroop stimuli will be practiced. The number of correct responses and reaction time of correct responses provided within testing will be recorded. To account for possible speed-accuracy trade-off, a composite score will be calculated by dividing accuracy (% correct responses) by verbal reaction time to indicate cognitive performance.
Measured: 1 minute
Auditory Stroop task
The Auditory Stroop task measures response inhibition (executive function).Inhibitory assessment of auditory Stroop task will include ignoring the distracter stimuli. Participants hear the words "papa" and "mama," spoken in either a male voice or a female voice; participants are instructed to report the voice of the word (papa/mama) as quickly and as accurately as possible, ignoring the actual word presented.
Measured: 1 minute
Spatial Memory Task (SM)
The SM measures spatial memory. A visuospatial cognition task will consist of visualizing and reciting directions. Two visual yellow stimuli on a 3 by 3 grid will be sequentially presented approximately 0.5 second each and then faded. Then participants have to identify the location of the two stimuli and respond verbally the corresponding numbers on a 3 by 3 grid based on the positions.
Measured: 1 minute
Choice Reaction Time Task (CRT)
The CRT measures selective attention. Participants hear either a high pitch (2500 Hz) or a low pitch (500 Hz) and are instructed to verbal report the pitch of the sound (high or low).
Measured: 1 minute
Secondary outcomes (5)
gait and cognitive performance under dual-task conditions
Participants will walk 10 meters at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In oder to allow the participants to have enough distance to accelerate and decelerate, only the time taken to walk in the middle 10 meters will be recorded by a stopwatch or Physilog sensors (Gait up, Switzerland). The primary gait parameter is gait speed (cm/sec) under dual-task walking conditions using the 10 Meter Walking Test plus the Stroop task. For walking while performing the Stroop task, we will calculate the composite score for the Stroop task under dual-task walking condition by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds) which accounts for speed-accuracy tradeoffs.
Measured: 20 minutes
dual-task Timed Up and GoTest (dual-TUG Test)
The dual-TUG Test is to perform the TUG Test under dual-task conditions (tray carrying and counting backward by 3s). Participants will be asked to perform the TUG test while carrying a tray with glasses (dual-TUG manual) or counting backward by 3s (dual-TUG cognition). The instruction for dual-TUG tests is to walk with your comfortable speed and concurrently perform a secondary task (carry the tray in front of you with both hands without dropping glasses on the tray or counting backward by 3s). The TUG test is often used as an index of dynamic balance of the elderly. At the signal, participants stand up, walk 3 meter, turn, walk back, and sit down again. The score is the time to complete the test measured using a stopwatch.
Measured: 2 minutes
Mini-Balance Evaluation System Test (Mini-BEST Test)
The Mini-BEST test consists of 14 items and includes four subscales: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is rated on a three-point ordinal scale (0=severe, 1=moderate, and 2=normal), with a maximum score of 28 points.
Measured: 10 minutes
Functional Gait Assessment (FGA)
The FGA is comprised of 10-item that contains 7 of 8 items (except walking around obstacles) from the Dynamic Gait Index and 3 additional tasks, including walking with a narrow base of support, walking with the eyes closed, and walking backward. Subjects' perfromance of each test item was rated on a 4-point scale (0-3), with the total score ranging between 0 and 30.
Measured: 10 minutes
6-minute Walk Test
Participants walk for 6-minute at comfortable speed to examine their walking endurance.
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start8 Mar 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-frail ElderlyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Ling Chuang, Chang Gung University
- Investigators
- LLi-Ling Chuang, Ph.D., Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605809
- Sponsor's protocol ID
- MOST 109-2314-B-182-030
- Status last verified
- Jan 2025
- First submitted
- 15 Oct 2020
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Motor and Cognitive Training on Physical Fitness and Brain Fitness in Pre-frail Elderly
- ClinicalTrials.gov ID
- NCT04605809
- Acronym / sponsor ID
- MOST 109-2314-B-182-030
- Conditions
- Pre-frail Elderly
- Keywords
- pre-frail, physical fitness, brain fitness, dual-task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Oct 2020 (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 objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of combined motor and cognitive training on physical fitness, brain fitness, and dual-task walking performance in pre-frail elderly. Specifically, we will investigate psychometric properties (i.e. reliability and validity) of dual-task walking assessments for pre-frail elderly (Aim 1). The second aim of this study is to compare the effects of combined motor and cognitive training vs. motor training alone vs. cognitive training alone vs. no intervention control on physical fitness, brain fitness, and dual-task walking performance in pre-frail elderly (Aim 2). The third aim of this study is to elucidate the effects of combined motor and cognitive training on patterns of cognitive motor interference in pre-frail elderly (Aim 3).
Detailed description
A metric analysis and comparative efficacy research will be conducted. Eighty-four pre-frail elderly will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the dual-task walking assessments will include walking at preferred speed and fast speed and simultaneously perform serial three subtractions and the Stroop task. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest), dual-task Timed-up-and-Go test (dual-TUG), and 6-min walk test obtain concurrently for assessing dual-task ability. A comparative efficacy research is a single-blind, randomized controlled trial, which will be conducted at medical centers. Pre-frail elderly will be randomized to combined motor and cognitive training, motor training alone, cognitive training alone, or no intervention control group. All three training groups will receive interventions 3 times a week for 4 weeks. The combined motor and cognitive training group will undertake physical fitness training under sitting and standing, walking training while sequentially or simultaneously perform cognitive training. The motor training alone group will train the same set of physical fitness training while sitting, standing, and walking as the combined motor and cognitive training group. The cognitive training alone group will train the same set of cognitive training while sitting as the combined motor and cognitive training group. No intervention control group will maintain habit and daily activity. A blinded assessor will administer three assessments. All participants will be examined physical fitness and brain fitness at baseline twice, and post intervention. The primary outcome measures will be components of physical fitness (cardiopulmonary fitness, muscle fitness, flexibility, body composition, and balance)and brain fitness (information processing speed, working memory, response inhibition, spatial memory, and selective attention). The secondary outcome measures will be gait and cognitive performance under dual-task conditions, dual-Timed Up and Go test, the Mini-BESTest, Functional Gait Assessment, and 6-minute Walk Test, Repeated measure ANOVA will be used to compare measurements at baseline and after training among the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| combined motor and cognitive training | Experimental | Device: combined motor and cognitive trainingThe combined motor and cognitive training group will undertake physical fitness training under sitting and standing, walking training while sequentially or simultaneously perform cognitive training. |
| motor training alone | Active comparator | Device: motor training aloneThe motor training alone group will train the same set of physical fitness training while sitting, standing, and walking as the combined motor and cognitive training group. |
| cognitive training alone | Active comparator | Device: cognitive training aloneThe cognitive training alone group will train the same set of cognitive training while sitting as the combined motor and cognitive training group. |
| no intervention control group. | No intervention | –No intervention control group will maintain habit and daily activity. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- age more than 65 years old
- fit one of the criteria for pre-frail definition: (1) body weight lost more than 3 kg or 5% as compared to last year; (2) unable to compete 5 times of Sit to Stand test within 15 seconds; (3 ) more than 3 days fatigue feeling or lack of motivation doing things.
- able to walk 10 meters
- no severe vision, hearing, cognition, and language problems.
- understand instruction (MoCA score>26)
Key exclusion criteria (4 listed)
- neurological or musculoskeletal diagnosis that affects walking
- cognitive impairment (MoCA<26)
- unable to stand for at least 2 minutes
- moderate to severe high blood pressure (systolic blood pressure more than 160 mmHg and diastolic blood pressure more than 100 mmHg)
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 |
|---|---|---|
| combined motor and cognitive trainingThe combined motor and cognitive training group will receive physical fitness training under sitting and standing, walking training while sequentially or simultaneously perform cognitive training for 45 minutes per session, 3 times a week for 4 weeks. | Device | combined motor and cognitive training |
| motor training aloneThe motor training alone group will receive the same set of physical fitness training while sitting, standing, and walking as the combined motor and cognitive training group for 45 minutes per session, 3 times a week for 4 weeks. | Device | motor training alone |
| cognitive training aloneThe cognitive training alone group will receive the same set of cognitive training while sitting as the combined motor and cognitive training group for 45 minutes per session, 3 times a week for 4 weeks. | Device | cognitive training alone |
Primary outcome
Body Mass Index (BMI)
Time frame: 1 minute
weight and height will be combined to report BMI in kg/m^2 measure body composition.
Waist to hip ratio
Time frame: 1 minute
waist to hip ratio measure body composition.
2-Minute Step Test
Time frame: 2 minutes
This test measures aerobic endurance. It requires the subjects march in place as fast as possible for 2 minutes while lifting the knees to a height midway between their patella and iliac crests while standing. The score is the number of right-knee reaches the required height completed in 2 minutes.
Chair Stand and Reach Test
Time frame: 1 minutes
This test measures lower body flexibility, especially hamstrings. The subject sits on the edge of a chair (placed against a wall for safety). One foot must remain flat on the floor. The other leg is extended forward with the knee straight, heel on the floot, and ankle bent at 90 degree. Place one hand on the top of the other with tips of the middle fingers even. Instruct the subject to inhale, and then as the exhale, reach forward toward the toes by bending at the hip. Knee the back straight and head up. Avoid bouncing or quick movements, and pain. Keep the knee straight , and hold the reach for 2 seconds. The distance is measured between the tip of the fingertips and the toes. If the fingertips touch toes then the score is zero. If they do not touch, measure the distance between the fingers and the toes as a negative score. If they overlap, measure by how much of the distance as a positive score.
Back Scratch Test
Time frame: 1 minutes
This test measures upper body flexibility, especially shoulder movement. This test requires the subject in standing position. Place one hand behind the head and back over the shoulder, and reach as far as possible down the middle of his/her back, his/her psalm touching his/her body and the fingers directed downwards. Place the other arm behind his/her back, palsm facing outward and fingers upward and reach up as far as possible attempting to touch or overlap the middle fingers of both hands. The examiner measures the distance between the tips of the middle fingers. If the fingertips touch, the score is zero. If they do not touch, measure the distance between the fingertips as a negative score. If they overlap, measure by how much of the distance as a positive score.
Arm Curl Test
Time frame: 1 minutes
This test measures upper body strength and endurance. The subject sits on a chair, holding the weight in the hand using a suitcase grip (palm facing towards the body) with the arm in a vertically down position beside the chair. Brace the upper arm against the body so that only the lower arm is moving (the examiner assists to hold the upper arm steady). Curl the arm up through a full range of motion, gradually turning the palm up (flexion with supination). As the arm is lowered through the full range of motion, gradually return to the starting position. The arm must be fully bent and then fully straightened at the elbow. Repeat this action as many times as possible within 30 seconds. The score is the numbers of the dominant arm curl within 30 seconds.
Chair Stand Test
Time frame: 1 minutes
This test measures leg strength and endurance. The subject is seated in the middle of the chair, back straight, feet approximately a shoulder width apart and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and help against the chest. Have the subject complete as many full stands as possible within 30 seconds. The subject is instructed to fully sit between each stand. The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand).
8-Foot Up and Go Test
Time frame: 1 minutes
This test measures mobility, balance, walking ability, and fall risk in older adults. The subject sits in the chair with his/her back against the chair back. On the command" Go" the subject rises from the chair, walk 2.44 meters at a fast and safe speed, turns, walk back to the chair and sit down. Timing begins at the instruction "Go" and stops when the subject is seated.
One-leg Standing Test
Time frame: 1 minutes
This test measures static balance control and is performed with eyes open (focus on an object about 3 feet in front of the subject), arms on the hips. The subject must stand unassisted on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg ot an arm leaves the hips.
Simple Reaction Time Task (SRT)
Time frame: 1 minute
It measures information processing speed.In a sitting position, participants will hear a sequential 5 low pitch (500Hz) that are played by a custom-written MatLab program and present stimuli through a wireless headphone. Participants are instructed to respond verbally the pitch of the sound (low) as quickly and as accurately as possible. Before actual measurements, a series of ten auditory stimuli will be practiced. The number of correct responses and reaction time of correct responses provided within testing will be calculated
Serial three subtraction task
Time frame: 1 minute
It measures working memory. In this task targeting working memory, participant will be instructed to count backwards by 3s from a two-digit number (eg, subtract 3 from 99 five times as fast as you can). After 2 trials of practice, another 2 trials will be conducted using 2 new number sets. In addition to accuracy and reaction time, the number of correct responses within the given time period of each trial will be calculated.
Stroop task
Time frame: 1 minute
It measures response inhibition.The assessment involves showing the participants words written using inks of various colors, and having the participants state the color of the ink. Participants will be asked to name the color with which a color word will be printed, for instance, if the word "blue" is printed in "red" ink, the participant will need to respond "red" to be correct. The words will be displayed on computer screen in front of participants. Participants will be instructed to name colors of a set of words as accurately and as fast as possible. Before actual measurements, a series of five Stroop stimuli will be practiced. The number of correct responses and reaction time of correct responses provided within testing will be recorded. To account for possible speed-accuracy trade-off, a composite score will be calculated by dividing accuracy (% correct responses) by verbal reaction time to indicate cognitive performance.
Auditory Stroop task
Time frame: 1 minute
The Auditory Stroop task measures response inhibition (executive function).Inhibitory assessment of auditory Stroop task will include ignoring the distracter stimuli. Participants hear the words "papa" and "mama," spoken in either a male voice or a female voice; participants are instructed to report the voice of the word (papa/mama) as quickly and as accurately as possible, ignoring the actual word presented.
Spatial Memory Task (SM)
Time frame: 1 minute
The SM measures spatial memory. A visuospatial cognition task will consist of visualizing and reciting directions. Two visual yellow stimuli on a 3 by 3 grid will be sequentially presented approximately 0.5 second each and then faded. Then participants have to identify the location of the two stimuli and respond verbally the corresponding numbers on a 3 by 3 grid based on the positions.
Choice Reaction Time Task (CRT)
Time frame: 1 minute
The CRT measures selective attention. Participants hear either a high pitch (2500 Hz) or a low pitch (500 Hz) and are instructed to verbal report the pitch of the sound (high or low).
5 secondary outcomes
gait and cognitive performance under dual-task conditions
Time frame: 20 minutes
dual-task Timed Up and GoTest (dual-TUG Test)
Time frame: 2 minutes
Mini-Balance Evaluation System Test (Mini-BEST Test)
Time frame: 10 minutes
Functional Gait Assessment (FGA)
Time frame: 10 minutes
6-minute Walk Test
Time frame: 6 minutes
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 13 Jan 2025.
- Individual participant dataSharing planned: No
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Spine Degeneration, Lumbar Degenerative Disease
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.
LLi-Ling Chuang, Ph.D. principal investigator
Chang Gung 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 combined motor and cognitive training, motor training alone and cognitive training alone in people with Pre-frail Elderly, run by Chang Gung 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 5 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: finished, as of the sponsor's last update on 13 Jan 2025. 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?
Body Mass Index (BMI) (time frame: 1 minute). The study lists 15 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 13 Jan 2025.