An interventional study of Resistance Training and Balance and Tone Training in Cognitive Impairment, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Western University, Canada · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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 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.
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.
Number of participants recruited after 12 months
Time frame: 12 months
Number of exercise classes attended at trial completion (6 months)
Time frame: 6 months
Change in cognitive function as measured by Alzheimer's Disease Assessment Scale - Cog - Plus (ADAS-Cog-Plus)
Time frame: 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.
Time frame: 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)
Time frame: Baseline and 6 months
Change in memory as measured by performance on associative memory task
Time frame: Baseline, 3 months, and 6 months
Change in executive functions as measured by Stroop Test
Time frame: Baseline, 3 months, and 6 months
Change in aerobic fitness as measured by six minute walk test
Time frame: Baseline, 3 months, and 6 months
Change in mobility and balance as measured by Short Physical Performance Battery
Time frame: Baseline, 3 months, and 6 months
Change in muscle strength as measured by one-repetition maximum test
Time frame: Baseline, 3 months, and 6 months
Change in blood glucose levels as measured by finger prick glucose test
Time frame: Baseline, 3 months, and 6 months
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Western University, Canada