Clinical trial NCT03254381: The Effect of Exercise on Cognition in Older Adults At-risk for Diabetes: A Feasibility Pilot Study
Official title: The Effect of Resistance Training on Cognitive Function and Brain Health in Older Adults At-risk for Diabetes: A Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: cognitive assessment
cognitive function
community dwelling older people
pre-diabetes
randomized control trial
exercise
pilot study
feasibility study
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants recruited after 12 months
timeFrame: 12 months
measure: Number of exercise classes attended at trial completion (6 months)
timeFrame: 6 months
Secondary outcomes:
measure: Change in cognitive function as measured by Alzheimer's Disease Assessment Scale - Cog - Plus (ADAS-Cog-Plus)
timeFrame: Baseline, 3 months, and 6 months
measure: Change in hippocampal volume as measured via high resolution T1 images collected during MRI scanning in both 3T and 7T machines.
timeFrame: Baseline and 6 months
measure: Change in hippocampal functional activation as measured during performance on associative memory task during fMRI scanning
timeFrame: Baseline and 6 months
measure: Change in memory as measured by performance on associative memory task
timeFrame: Baseline, 3 months, and 6 months
measure: Change in executive functions as measured by Stroop Test
timeFrame: Baseline, 3 months, and 6 months
measure: Change in aerobic fitness as measured by six minute walk test
timeFrame: Baseline, 3 months, and 6 months
measure: Change in mobility and balance as measured by Short Physical Performance Battery
timeFrame: Baseline, 3 months, and 6 months
measure: Change in muscle strength as measured by one-repetition maximum test
timeFrame: Baseline, 3 months, and 6 months
measure: Change in blood glucose levels as measured by finger prick glucose test
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Community
state: Ontario
Study officials:
affiliation: Western University
name: Lindsay S Nagamatsu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.