Effects of Step Training in Older Adults with Mild Dementia

NCT05655403 | Recruiting

• 1 other identifier: 20221201007
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Step training; Falls; Dementia; Randomized controlled trial; Prefrontal cortex

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-intervention (week 12)

Secondary Outcomes (6)

• Prefrontal cortex (PFC) functioning during choice stepping

  Post-intervention (week 12)

• Maximum step length test (MSLT)

  Post-intervention (week 12)

• 30-second sit-to-stand test (30STS)

  Post-intervention (week 12)

• Berg Balance Scale (BBS)

  Post-intervention (week 12)

• Iconographical Fall Efficacy Scale - Chinese version (Icon-FES)

  Post-intervention (week 12)

Study Arms (2)

Step training group

EXPERIMENTAL

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.

Behavioral: Step training program

Wait-list control group

ACTIVE COMPARATOR

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.

Behavioral: Step training program

Interventions

Step training program BEHAVIORAL

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.

Step training group; Wait-list control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• University Grants Committee, Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Wayne LS Chan, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wayne LS Chan, PhD

CONTACT

+852 27666742; wayne.ls.chan@polyu.edu.hk

Study Design

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

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 19, 2022
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)