Effects of Combined Motor and Cognitive Training in Pre-frail Elderly

NCT04605809, Not applicable, Completed, Chang Gung University

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Effects of Combined Motor and Cognitive Training in Pre-frail Elderly	ClinicalTrials.gov
NCT number	NCT04605809	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	93 participants, actual	ClinicalTrials.gov
Lead sponsor	Chang Gung University	ClinicalTrials.gov
Conditions	Pre-frail Elderly	ClinicalTrials.gov
Interventions	combined motor and cognitive training, motor training alone, cognitive training alone	ClinicalTrials.gov
First posted	2020-10-28	ClinicalTrials.gov
Last updated	2025-01-13	ClinicalTrials.gov

Registered outcomes 20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Body Mass Index (BMI)	1 minute	weight and height will be combined to report BMI in kg/m\^2 measure body composition.	ClinicalTrials.gov
Primary	Waist to hip ratio	1 minute	waist to hip ratio measure body composition.	ClinicalTrials.gov
Primary	2-Minute Step Test	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.	ClinicalTrials.gov
Primary	Chair Stand and Reach Test	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.	ClinicalTrials.gov
Primary	Back Scratch Test	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.	ClinicalTrials.gov
Primary	Arm Curl Test	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.	ClinicalTrials.gov
Primary	Chair Stand Test	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).	ClinicalTrials.gov
Primary	8-Foot Up and Go Test	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.	ClinicalTrials.gov
Primary	One-leg Standing Test	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.	ClinicalTrials.gov
Primary	Simple Reaction Time Task (SRT)	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	ClinicalTrials.gov
Primary	Serial three subtraction task	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.	ClinicalTrials.gov
Primary	Stroop task	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.	ClinicalTrials.gov
Primary	Auditory Stroop task	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.	ClinicalTrials.gov
Primary	Spatial Memory Task (SM)	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.	ClinicalTrials.gov
Primary	Choice Reaction Time Task (CRT)	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).	ClinicalTrials.gov
Secondary	gait and cognitive performance under dual-task conditions	20 minutes	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.	ClinicalTrials.gov
Secondary	dual-task Timed Up and GoTest (dual-TUG Test)	2 minutes	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.	ClinicalTrials.gov
Secondary	Mini-Balance Evaluation System Test (Mini-BEST Test)	10 minutes	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.	ClinicalTrials.gov
Secondary	Functional Gait Assessment (FGA)	10 minutes	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.	ClinicalTrials.gov
Secondary	6-minute Walk Test	6 minutes	Participants walk for 6-minute at comfortable speed to examine their walking endurance.	ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units	Source

Participant flow 0

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted	Source

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source

Adverse event totals 0

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Choice Reaction Time	Primary outcome	ConductCognition
Simple Reaction Time	Primary outcome	ConductCognition
Stroop Color-Word Test	Primary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)