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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254381
• Other study ID #: 109379
• Status: Completed
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: October 3, 2019

Study information

• Verified date: December 2023
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 3, 2019
• Est. primary completion date: October 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Community	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited after 12 months		12 months
Primary	Number of exercise classes attended at trial completion (6 months)		6 months
Secondary	Change in cognitive function as measured by Alzheimer's Disease Assessment Scale - Cog - Plus (ADAS-Cog-Plus)		Baseline, 3 months, and 6 months
Secondary	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
Secondary	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
Secondary	Change in memory as measured by performance on associative memory task		Baseline, 3 months, and 6 months
Secondary	Change in executive functions as measured by Stroop Test		Baseline, 3 months, and 6 months
Secondary	Change in aerobic fitness as measured by six minute walk test		Baseline, 3 months, and 6 months
Secondary	Change in mobility and balance as measured by Short Physical Performance Battery		Baseline, 3 months, and 6 months
Secondary	Change in muscle strength as measured by one-repetition maximum test		Baseline, 3 months, and 6 months
Secondary	Change in blood glucose levels as measured by finger prick glucose test		Baseline, 3 months, and 6 months