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Effects of Step Training in Older Adults With Mild Dementia

Primary Purpose

Dementia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Step training program
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Step training, Falls, Dementia, Randomized controlled trial, Prefrontal cortex

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: at least 65 years old; have a physician's diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition; have mild dementia, indicated by a score of 10 or higher on the Montreal Cognitive Assessment Hong Kong version (HK-MoCA); able to walk 10 meters independently without a walking aid; receiving care by an unpaid "main caregiver" with at least 3.5 hours of face-to-face contact per week. Exclusion Criteria: unable to perform step training due to unstable or severe musculoskeletal, cardiorespiratory, or neurological conditions; have severe hearing and/or visual impairments that limit their ability to communicate; have been hospitalized within the past 30 days.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Step training group

Wait-list control group

Arm Description

The participants assigned to the ST condition will receive a 40-minute ST session twice a week for 12 weeks. The sessions will be delivered at community centers for older adults by an instructor with at least 5 years of experience in dementia care. Each session will consist of a 5-minute flexibility exercise warm-up, a 30-minute stepping exercise, and a 5-minute cool-down. A non-slip plastic mat marked with two standing panels and a number of removable stepping panels that can be secured to the plastic mat using hook-and-loop fasteners will be used as the exercise device. While standing on the standing panels, the participants will receive verbal instructions to (1) use one of their feet to step on a specific stepping panel and (2) return the stepping foot to the standing panel multiple times throughout every session.

The participants assigned to the WC condition will then receive usual care for 12 weeks. After completing the 12-week assessment, they will complete the ST program.

Outcomes

Primary Outcome Measures

Choice stepping reaction time test (CSRTT)
Participants will be asked to stand on a non-slip plastic mat marked with two standing panels and four stepping panels. The RA will provide verbal instructions to (1) use one foot to step on a stepping panel to the front or the side and (2) return the stepping foot to the standing panel. The participants will complete 20 stepping trials as quickly as possible based on a fixed pre-determined sequence. The first 8 trials will be regarded as practice trials. The total time to complete the last 12 trials will be measured in seconds using a stopwatch.

Secondary Outcome Measures

Prefrontal cortex (PFC) functioning during choice stepping
fNIRS will be used to measure PFC activity during stepping tasks. Participants will be asked to stand on the same plastic mat used in the CSRTT. They will be asked to finish 2 rounds of stepping tasks, with 8 stepping blocks in each round and 8 stepping trials per block (i.e., active periods). The stepping performance of the participants will be videotaped using a handheld camera, and the number of correct and incorrect steps taken according to the verbal cues provided will be counted. Each stepping round will consist of 4 simple and 4 choice stepping blocks. In the simple stepping block, the participants will be verbally instructed to use the same foot to repeatedly step on the same panel. In the choice stepping block, they will be asked to use either the left or right foot to step on different panels in each trial.
Maximum step length test (MSLT)
Participants will be asked to use their left or right foot to step 1) forward, (2) sideways, and (3) backward as far as they can without losing their balance. The mean distance covered in 5 stepping trials for each foot and direction will be recorded separately.
30-second sit-to-stand test (30STS)
Participants will be asked to repeatedly rise from a chair and sit down. The number of repetitions completed in 30 seconds will be recorded.
Berg Balance Scale (BBS)
The BBS consists of 14 items measuring the balance performance during daily functional activities, such as chair transfer, standing with eyes closed, turning 360 degrees, tandem standing, and single-leg standing. The total score ranges from 0 to 56, with a higher score indicating better balance.
Iconographical Fall Efficacy Scale - Chinese version (Icon-FES)
The Icon-FES uses a combination of illustrations to assess concerns about falling during 10 daily activities, such as changing clothes, taking a shower, and changing a light bulb. The total score ranges from 0 to 40, with a higher score indicating a greater fear of falling.
Timed Up and Go Single Task (TUG-S) and Timed Up and Go Dual Task (TUG-D)
In the TUG-S, the participants will be instructed to rise from an armchair, walk 3 meters, turn 180 degrees, walk back to the chair, and sit down at their own pace, and the time taken to complete the task will be recorded. For the TUG-D, the participants will be asked to perform the TUG-S while simultaneously naming as many animals as possible. The time used to complete the TUG-D and the dual-task cost (i.e., the time difference between the TUG-D and TUG-S) will be recorded.

Full Information

First Posted
December 2, 2022
Last Updated
December 15, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
University Grants Committee, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05655403
Brief Title
Effects of Step Training in Older Adults With Mild Dementia
Official Title
Investigating the Effects of Step Training and the Mediating Effects of Prefrontal Cortex Functioning in Older Adults With Mild Dementia: a Randomized Wait-list Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
University Grants Committee, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Step training has been shown to be effective at reducing the incidence of falls and improving related risk factors, including choice stepping, in healthy older adults. However, the effects of step training have not been investigated in OWMD. The primary objective of the proposed project will be to assess the effects of a step-training program involving concurrent stepping and visuospatial tasks on choice stepping, prefrontal cortex functioning during choice stepping, and fall-related outcomes (i.e., step length, lower-limb muscle strength, balance, mobility, dual-task ability, and fear of falling) in OWMD. The prefrontal cortex is responsible for the executive functions such as attention and inhibitory function, which are integral to choice stepping reaction time tasks. However, the effects of step training on prefrontal cortex functioning during choice stepping in OWMD remain unclear. The neural mechanisms underlying the potential effects of step training on choice stepping have never been investigated in this population. Therefore, the secondary objective of the proposed project will be to evaluate the mediating effects of changes in the prefrontal cortex functioning during choice stepping on the potential benefits of a step-training program for choice stepping in OWMD. The proposed project will provide robust evidence to support the use of step training to improve choice stepping and reduce the risk of falls in OWMD. Disentangling the neural mechanisms underlying the effects of step training will be crucial to the development of the most effective interventions to target these mechanisms.
Detailed Description
Falls are common in older adults with mild dementia (OWMD), and they are the leading cause of functional dependence, morbidity, and mortality in this population. The ability to take rapid, accurate, and effective steps in varied environmental conditions, such as walking on a wet floor or rough terrain, is crucial to ensuring safety and avoiding falls. OWMD often have difficulties in choice stepping (i.e., stepping on a specific target, while avoiding irrelevant distractions), which requires high levels of sensorimotor and cognitive function. As impaired choice stepping has been shown to predict falls in the general older population, improving choice stepping is expected to reduce the risk of falls in OWMD. Step training has been shown to be effective at reducing the incidence of falls and improving related risk factors, including choice stepping, in healthy older adults. However, the effects of step training have not been investigated in OWMD. The primary objective of the proposed project will be to assess the effects of a step-training program involving concurrent stepping and visuospatial tasks on choice stepping, prefrontal cortex functioning during choice stepping, and fall-related outcomes (i.e., step length, lower-limb muscle strength, balance, mobility, dual-task ability, and fear of falling) in OWMD. The prefrontal cortex is responsible for the executive functions such as attention and inhibitory function, which are integral to choice stepping reaction time tasks. However, the effects of step training on prefrontal cortex functioning during choice stepping in OWMD remain unclear. The neural mechanisms underlying the potential effects of step training on choice stepping have never been investigated in this population. Therefore, the secondary objective of the proposed project will be to evaluate the mediating effects of changes in the prefrontal cortex functioning during choice stepping on the potential benefits of a step-training program for choice stepping in OWMD. The proposed project will provide robust evidence to support the use of step training to improve choice stepping and reduce the risk of falls in OWMD. Disentangling the neural mechanisms underlying the effects of step training will be crucial to the development of the most effective interventions to target these mechanisms. Furthermore, the scientific evidence derived from the proposed project will motivate patients, caregivers, and clinicians to participate in such programs, and subsequently, relieve the fall-related burdens on multiple stakeholders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Step training, Falls, Dementia, Randomized controlled trial, Prefrontal cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Step training group
Arm Type
Experimental
Arm Description
The participants assigned to the ST condition will receive a 40-minute ST session twice a week for 12 weeks. The sessions will be delivered at community centers for older adults by an instructor with at least 5 years of experience in dementia care. Each session will consist of a 5-minute flexibility exercise warm-up, a 30-minute stepping exercise, and a 5-minute cool-down. A non-slip plastic mat marked with two standing panels and a number of removable stepping panels that can be secured to the plastic mat using hook-and-loop fasteners will be used as the exercise device. While standing on the standing panels, the participants will receive verbal instructions to (1) use one of their feet to step on a specific stepping panel and (2) return the stepping foot to the standing panel multiple times throughout every session.
Arm Title
Wait-list control group
Arm Type
Active Comparator
Arm Description
The participants assigned to the WC condition will then receive usual care for 12 weeks. After completing the 12-week assessment, they will complete the ST program.
Intervention Type
Behavioral
Intervention Name(s)
Step training program
Intervention Description
The program will consist of 3 phases: (1) getting familiar, (2) increasing complexity, and (3) consolidating skills. In Phase 1, the participants will be asked to use one foot to step on single-colored stepping panels located in a specific region of the plastic mat (e.g., upper quadrant). In Phase 2, the exercise will progress by introducing the following 4 cognitively challenging stepping tasks. After finishing the 4 stepping tasks in Phase 2, the exercises will progress to Phase 3, which will consolidate the participants' stepping and cognitive skills. The following 4 additional stepping tasks will be introduced. The instructor will tailor the exercises for each participant, based on their training performance.
Primary Outcome Measure Information:
Title
Choice stepping reaction time test (CSRTT)
Description
Participants will be asked to stand on a non-slip plastic mat marked with two standing panels and four stepping panels. The RA will provide verbal instructions to (1) use one foot to step on a stepping panel to the front or the side and (2) return the stepping foot to the standing panel. The participants will complete 20 stepping trials as quickly as possible based on a fixed pre-determined sequence. The first 8 trials will be regarded as practice trials. The total time to complete the last 12 trials will be measured in seconds using a stopwatch.
Time Frame
Post-intervention (week 12)
Secondary Outcome Measure Information:
Title
Prefrontal cortex (PFC) functioning during choice stepping
Description
fNIRS will be used to measure PFC activity during stepping tasks. Participants will be asked to stand on the same plastic mat used in the CSRTT. They will be asked to finish 2 rounds of stepping tasks, with 8 stepping blocks in each round and 8 stepping trials per block (i.e., active periods). The stepping performance of the participants will be videotaped using a handheld camera, and the number of correct and incorrect steps taken according to the verbal cues provided will be counted. Each stepping round will consist of 4 simple and 4 choice stepping blocks. In the simple stepping block, the participants will be verbally instructed to use the same foot to repeatedly step on the same panel. In the choice stepping block, they will be asked to use either the left or right foot to step on different panels in each trial.
Time Frame
Post-intervention (week 12)
Title
Maximum step length test (MSLT)
Description
Participants will be asked to use their left or right foot to step 1) forward, (2) sideways, and (3) backward as far as they can without losing their balance. The mean distance covered in 5 stepping trials for each foot and direction will be recorded separately.
Time Frame
Post-intervention (week 12)
Title
30-second sit-to-stand test (30STS)
Description
Participants will be asked to repeatedly rise from a chair and sit down. The number of repetitions completed in 30 seconds will be recorded.
Time Frame
Post-intervention (week 12)
Title
Berg Balance Scale (BBS)
Description
The BBS consists of 14 items measuring the balance performance during daily functional activities, such as chair transfer, standing with eyes closed, turning 360 degrees, tandem standing, and single-leg standing. The total score ranges from 0 to 56, with a higher score indicating better balance.
Time Frame
Post-intervention (week 12)
Title
Iconographical Fall Efficacy Scale - Chinese version (Icon-FES)
Description
The Icon-FES uses a combination of illustrations to assess concerns about falling during 10 daily activities, such as changing clothes, taking a shower, and changing a light bulb. The total score ranges from 0 to 40, with a higher score indicating a greater fear of falling.
Time Frame
Post-intervention (week 12)
Title
Timed Up and Go Single Task (TUG-S) and Timed Up and Go Dual Task (TUG-D)
Description
In the TUG-S, the participants will be instructed to rise from an armchair, walk 3 meters, turn 180 degrees, walk back to the chair, and sit down at their own pace, and the time taken to complete the task will be recorded. For the TUG-D, the participants will be asked to perform the TUG-S while simultaneously naming as many animals as possible. The time used to complete the TUG-D and the dual-task cost (i.e., the time difference between the TUG-D and TUG-S) will be recorded.
Time Frame
Post-intervention (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least 65 years old; have a physician's diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition; have mild dementia, indicated by a score of 10 or higher on the Montreal Cognitive Assessment Hong Kong version (HK-MoCA); able to walk 10 meters independently without a walking aid; receiving care by an unpaid "main caregiver" with at least 3.5 hours of face-to-face contact per week. Exclusion Criteria: unable to perform step training due to unstable or severe musculoskeletal, cardiorespiratory, or neurological conditions; have severe hearing and/or visual impairments that limit their ability to communicate; have been hospitalized within the past 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wayne LS Chan, PhD
Phone
+852 27666742
Email
wayne.ls.chan@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne LS Chan, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Step Training in Older Adults With Mild Dementia

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