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

NCT04605809 | Completed

• 1 other identifier: MOST 109-2314-B-182-030
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pre-frail Elderly

Keywords

pre-frail, physical fitness, brain fitness, dual-task

Outcome Measures

Primary Outcomes (15)

• Body Mass Index (BMI)

  weight and height will be combined to report BMI in kg/m\^2 measure body composition.

  1 minute

• Waist to hip ratio

  waist to hip ratio measure body composition.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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).

  1 minute

Secondary Outcomes (5)

• gait and cognitive performance under dual-task conditions

  20 minutes

• dual-task Timed Up and GoTest (dual-TUG Test)

  2 minutes

• Mini-Balance Evaluation System Test (Mini-BEST Test)

  10 minutes

• Functional Gait Assessment (FGA)

  10 minutes

• 6-minute Walk Test

  6 minutes

Study Arms (4)

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.

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.

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.

Device: cognitive training alone

no intervention control group.

NO INTERVENTION

No intervention control group will maintain habit and daily activity.

Interventions

combined motor and cognitive training DEVICE

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.

combined motor and cognitive training

motor training alone DEVICE

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.

motor training alone

cognitive training alone DEVICE

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.

cognitive training alone

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Mackay Memory Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• LLi-Ling Chuang, Ph.D.

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 28, 2020
• Study Start: March 8, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)