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

NCT ID: NCT04605809

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2024-07-31

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

combined motor and cognitive training

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.

Group Type: EXPERIMENTAL

combined motor and cognitive training

Intervention Type: 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.

motor training alone

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.

Group Type: ACTIVE_COMPARATOR

motor training alone

Intervention Type: 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.

cognitive training alone

The cognitive training alone group will train the same set of cognitive training while sitting as the combined motor and cognitive training group.

Group Type: ACTIVE_COMPARATOR

cognitive training alone

Intervention Type: 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.

no intervention control group.

No intervention control group will maintain habit and daily activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung University

OTHER

Sponsor Role: lead

Responsible Party

Li-Ling Chuang

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LLi-Ling Chuang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

Mackay Memory Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

MOST 109-2314-B-182-030

Identifier Type: -

Identifier Source: org_study_id