Clinical trial NCT04605809: Effects of Combined Motor and Cognitive Training in Pre-frail Elderly
Official title: Effects of Combined Motor and Cognitive Training on Physical Fitness and Brain Fitness in Pre-frail Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-frail Elderly
Keywords: pre-frail, physical fitness, brain fitness, dual-task
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 93
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 1 minute
measure: Waist to hip ratio
timeFrame: 1 minute
measure: 2-Minute Step Test
timeFrame: 2 minutes
measure: Chair Stand and Reach Test
timeFrame: 1 minutes
measure: Back Scratch Test
timeFrame: 1 minutes
measure: Arm Curl Test
timeFrame: 1 minutes
measure: Chair Stand Test
timeFrame: 1 minutes
measure: 8-Foot Up and Go Test
timeFrame: 1 minutes
measure: One-leg Standing Test
timeFrame: 1 minutes
measure: Simple Reaction Time Task (SRT)
timeFrame: 1 minute
measure: Serial three subtraction task
timeFrame: 1 minute
measure: Stroop task
timeFrame: 1 minute
measure: Auditory Stroop task
timeFrame: 1 minute
measure: Spatial Memory Task (SM)
timeFrame: 1 minute
measure: Choice Reaction Time Task (CRT)
timeFrame: 1 minute
Secondary outcomes:
measure: gait and cognitive performance under dual-task conditions
timeFrame: 20 minutes
measure: dual-task Timed Up and GoTest (dual-TUG Test)
timeFrame: 2 minutes
measure: Mini-Balance Evaluation System Test (Mini-BEST Test)
timeFrame: 10 minutes
measure: Functional Gait Assessment (FGA)
timeFrame: 10 minutes
measure: 6-minute Walk Test
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memory Hospital
Study officials:
affiliation: Chang Gung University
name: LLi-Ling Chuang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: