The Effect of Exercise on Cognition in Older Adults At-risk for Diabetes: A Feasibility Pilot Study

The Effect of Resistance Training on Cognitive Function and Brain Health in Older Adults At-risk for Diabetes: A Feasibility Pilot Study

Older adults with type 2 diabetes experience cognitive decline and are at higher risk for developing dementia. Consequently, older adults at-risk for developing type 2 diabetes (based on body mass, glucose levels) are at higher risk for cognitive decline, and intervening at this point may prevent or delay the onset of such decline. One promising lifestyle intervention that has been shown to improve cognitive function in other populations is exercise. However, before investigators can examine whether exercise will improve cognitive function and brain health (structure and function) in this at-risk population, a feasibility pilot study is needed to determine whether a larger-scale trial would be viable.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment
• Intervention / Treatment: Behavioral: Resistance Training; Behavioral: Balance and Tone Training

Detailed Description

Investigators will conduct a six-month randomized control trial (RCT) exercise intervention. Thirty older adults (aged 60-80) at-risk for diabetes will be randomly assigned into one of two groups: 1) Resistance training, or 2) Balance and Tone training (control). All participants will engage in three one-hour exercise classes per week. Once a month, a neutral assessor will visit the classes to evaluate the quality of the classes for participants. Assessments will be made at baseline, midpoint (three months) and trial completion (six months), and will include cognitive testing, health questionnaires, physical testing, and magnetic resonance imaging (MRI; to assess structural and functional brain changes). Throughout the study, investigators will examine data for trends in successful recruitment strategies and rates of recruitment and adherence to inform future clinical trials in this population. Research assistants (n = 30) in the study will complete an anonymous feedback survey upon completion of their volunteer term, to assist in improving the study for future participants and volunteers.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1) be community-dwelling 2) be aged 60-80 years 3) be "at-risk" for diabetes, where they have one of the following: i) blood glucose level of 6.1-7 mmol/L, ii) BMI > 25, or iii) score > 21 on the CANRISK diabetes questionnaire 4) score > 24/30 on MMSE 5) score > 6/8 on Lawton and Brody's Independent Activities of Daily Living (IADL) scale 6) have visual acuity of at least 20/40, with or without corrective lenses 7) speak and understand English fluently 8) complete the Physical Activity Readiness Questionnaire (PAR-Q) 9) obtain physician's clearance to start a supervised exercise program

Exclusion Criteria:

1) have a current medical condition for which exercise is contraindicated 2) have participated regularly in resistance or aerobic training in the last 6 months 3) have been diagnosed with neurodegenerative disease (including dementia, Alzheimer's disease, or Parkinson's disease) 4) have experienced a vascular incident (e.g., stroke, myocardial infarction) 5) have been diagnosed with a psychiatric condition 6) have untreated depression 7) are currently on hormone replacement therapy 8) have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease 9) are currently taking psychotropic medications 10) are unable to participate in MRI (have metal or electronic implants, or are claustrophobic)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance Training; Participants will use programmable weight machines along with free weights to target primary muscle groups. In addition, they will complete mini-squats, mini-lunges, and lunge walks. Participants will complete two sets of 6-8 reps. Training stimulus will be increased using the 7RM method - when 2 sets of 6-8 reps are completed with proper form and without discomfort. Investigators will record the number of sets completed and the load lifted for each exercise for each participant at every class.	Behavioral: Resistance Training; Six months of thrice-weekly resistance training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down). Classes will be group classes, with up to five participants in each.
Experimental: Balance and Tone Training (Control); Exercises will include stretching exercises, range of motion exercises, basic core-strength exercises, balance exercises, and relaxation techniques. Only bodyweight will be applied (i.e., no additional loading). This group controls for confounding variables such as physical training received by traveling to the training centres, social interaction, and changes in lifestyle secondary to study participation.	Behavioral: Balance and Tone Training; Six months of thrice-weekly stretching and relaxation exercises. Each session will be 60 minutes. Classes will be group classes, with up to five participants in each.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants recruited after 12 months	12 months
Number of exercise classes attended at trial completion (6 months)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive function as measured by Alzheimer's Disease Assessment Scale - Cog - Plus (ADAS-Cog-Plus)		Baseline, 3 months, and 6 months
Change in hippocampal volume as measured via high resolution T1 images collected during MRI scanning in both 3T and 7T machines.		Baseline and 6 months
Change in hippocampal functional activation as measured during performance on associative memory task during fMRI scanning	For this task, participants will be asked to encode and then recall items (face or places) and items in conjunction (faces matched with places)	Baseline and 6 months
Change in memory as measured by performance on associative memory task		Baseline, 3 months, and 6 months
Change in executive functions as measured by Stroop Test		Baseline, 3 months, and 6 months
Change in aerobic fitness as measured by six minute walk test		Baseline, 3 months, and 6 months
Change in mobility and balance as measured by Short Physical Performance Battery		Baseline, 3 months, and 6 months
Change in muscle strength as measured by one-repetition maximum test		Baseline, 3 months, and 6 months
Change in blood glucose levels as measured by finger prick glucose test		Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Lindsay S Nagamatsu, Western University

Publications and helpful links

General Publications

• Furlano JA, Nagamatsu LS. Feasibility of a 6-month pilot randomised controlled trial of resistance training on cognition and brain health in Canadian older adults at-risk for diabetes: study protocol. BMJ Open. 2019 Oct 3;9(10):e032047. doi: 10.1136/bmjopen-2019-032047.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): October 3, 2019
• Study Completion (Actual): October 3, 2019

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: exercise; cognitive function; pilot study; feasibility study; randomized control trial; pre-diabetes; cognitive assessment; community dwelling older people
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 109379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No