NCT02730013

Brief Summary

This is a 3 month cluster randomized controlled trial using a square-stepping exercise program (a.k.a. mind-motor exercise) in retirement and long-term care residences to improve global cognitive functioning in older adults with and without cognitive impairments. The investigators intend this project to be pragmatic and therefore will include residents with dementia and walking aids if the participants wish to participate. The primary outcome is global cognitive functioning, secondary outcomes include: single and dual task gait (only completed with those without dementia), oculomotor functioning, and functional fitness. The investigators hypothesize that there will be improvements in primary and secondary outcomes in the intervention group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

June 25, 2018

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

March 31, 2016

Last Update Submit

June 20, 2018

Conditions

Cognitive Decline

Keywords

Older adultsSquare stepping exerciseMind-motor exerciseLong-term careGlobal cognitive functioning

Outcome Measures

Primary Outcomes (1)

  • Composite score from Cambridge Brain Sciences Cognitive Battery

    To assess global cognitive function.

    Change from 0 to 12 weeks

Secondary Outcomes (12)

  • Gait variability (stride time) under dual-task conditions

    Change from 0 to 12 weeks

  • Gait variability (stride time) under single-task conditions

    Change from 0 to 12 weeks

  • Gait velocity (speed) under dual-task conditions

    Change from 0 to 12 weeks

  • Gait velocity (speed) under single-task conditions

    Change from 0 to 12 weeks

  • Step length (average) under dual-task conditions

    Change from 0 to 12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Square Stepping Exercise

EXPERIMENTAL

Square-Stepping Exercise (SSE) Intervention Participants in this group will attend a square-stepping exercise intervention 60 minutes: 5 minute for attendance, 5-10 minute warm-up 40-45 minute SSE and 5-10 minute cool-down, on two days a week for a duration of 12 weeks.

Behavioral: Square Stepping Exercise

Usual-care wait-list control

NO INTERVENTION

This group will receive standard care and be invited to partake in the intervention after all assessments have been completed.

Interventions

Square Stepping ExerciseBEHAVIORAL

Square Stepping Exercise involves mimicking a stepping pattern demonstrated by an instructor. The stepping patterns become progressively difficult and involve forward, backward, lateral and diagonal movements on a 250cm long mat with 25cm square grids. In a group setting, an instructor will demonstrate walking patterns on a gridded mat to the participants and the participants must memorize and repeat the patterns on their own. This program has over 200 patterns that increase in difficulty from beginner to advanced. Eighty percent of the group must successfully complete the patterns to move onto the next pattern. Social engagement is encouraged.

Also known as: Mind-motor exercise
Square Stepping Exercise

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All residents of the 4 Schlegel Villages: Glendale Crossing, St. Clair, Tansley Woods, Winston Park
  • Both males and females

You may not qualify if:

  • Wheelchair bound residents
  • Residents who are blind or deaf without aids
  • Any residents who may not be able to participate due to health or behaviours in collaboration and discretion of the Schlegel Villages staff.
  • Residents who have a diagnosis of dementia, have a score of greater than 3 on the Cognitive Performance Scale (determined by each Schlegel Village) and advice from Schlegel Villages staff will be excluded from specific assessments (dual-task gait; oculomotor function; global cognitive functioning outcomes; Montreal Cognitive Assessment; 2 cognitive questions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Centre for Public Health and Family Medicine, Western University

London, Ontario, N6G 2M1, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Robert Petrella, MD, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

June 25, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)