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

Pre-frail Elderly Clinical Trial

Official title:

Effects of Combined Motor and Cognitive Training on Physical Fitness and Brain Fitness in Pre-frail Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04605809
• Other study ID #: MOST 109-2314-B-182-030
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Chang Gung University
• Contact: Li-Ling Chuang, Ph.D.
• Phone: 886-3-2118800
• Email: lchuang[@]gap.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Pre-frail Elderly

Intervention

Device:
• combined motor and cognitive training
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 alone
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 alone
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.

Locations

Country	Name	City	State
Taiwan	Mackay Memory Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	weight and height will be combined to report BMI in kg/m^2 measure body composition.	1 minute
Primary	Waist to hip ratio	waist to hip ratio measure body composition.	1 minute
Primary	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.	2 minutes
Primary	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.	1 minutes
Primary	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.	1 minutes
Primary	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.	1 minutes
Primary	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).	1 minutes
Primary	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.	1 minutes
Primary	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.	1 minutes
Primary	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	1 minute
Primary	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.	1 minute
Primary	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.	1 minute
Primary	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.	1 minute
Primary	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.	1 minute
Primary	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).	1 minute
Secondary	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.	20 minutes
Secondary	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.	2 minutes
Secondary	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.	10 minutes
Secondary	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.	10 minutes
Secondary	6-minute Walk Test	Participants walk for 6-minute at comfortable speed to examine their walking endurance.	6 minutes