Mind-motor Exercise in Older Adults With Type 2 Diabetes and Self-reported Cognitive Complaints

NCT02292511 | Completed

• 1 other identifier: D-SSE-123
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a 6 month mind-motor intervention will help to improve overall brain health in adults over the age of 55 with type 2 diabetes and a self-reported complaint about memory or thinking skills. It is hypothesized that the intervention group will show improvements in their overall brain health after 6 months of mind-motor training compared to the control group.

Conditions

Type 2 Diabetes Mellitus

Keywords

subjective cognitive impairment; mind-motor intervention; square-stepping exercise; older adults

Outcome Measures

Primary Outcomes (1)

• Global Cognitive Functioning

  measured by Cambridge Brain Sciences - composite score from 12 tasks

  Change from 0 to 24 weeks

Secondary Outcomes (10)

• Global Cognitive Functioning

  Change from 0 to 12 weeks

• Memory composite score

  Change from 0 to 12 & 24 weeks

• Reasoning composite score

  Change from 0 to 12 & 24 weeks

• Concentration composite score

  Change from 0 to 12 & 24 weeks

• Planning (executive functioning) composite score

  Change from 0 to 12 & 24 weeks

Study Arms (2)

Square-Stepping Exercise Intervention

EXPERIMENTAL

Participants in this group will attend a square-stepping exercise intervention 60 minutes on two days a week at a community location.

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 exercise BEHAVIORAL

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 Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 years of age or older
• Stable type 2 diabetes (i.e. A1c \<9.0 for at least 6 months)
• Self report a cognitive complaint (i.e answer yes to: do you feel your memory and/or thinking skills have gotten worse recently?)

You may not qualify if:

• Participants must be able to comprehend the letter of information and provide consent.
• Participants cannot have
• major depression, measured by Center of Epidemiologic Studies Depression Scale (CES-D) and study physician consult,
• diagnosis of dementia, or score \<24 on mini-mental state examination (MMSE)
• other significant neurological disorder or psychiatric conditions
• severe history of cardiovascular events
• severe orthopedic limitations
• uncontrolled diabetes (i.e A1c \<4.0mmol/L or \>9.0mmol/L)
• unstable angina
• untreated retinopathy
• foot ulcers with or without severe peripheral neuropathy
• severe sensory impairment (i.e. blind).
• Finally, participants must plan to attend at least 75% of the sessions over the 24-week period; this is to ensure adequate compliance of the program.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Primary Care Diabetes Support Program

London, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Robert J Petrella, MD, PhD

  University of Western Ontario, Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 17, 2014
• Study Start: February 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)