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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03254381
Other study ID # 109379
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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