The Effect of Exercise on Cognition in Older Adults At-risk for Diabetes: A Feasibility Pilot Study
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|ClinicalTrials.gov Identifier: NCT03254381|
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment||Behavioral: Resistance Training Behavioral: Balance and Tone Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Resistance Training on Cognitive Function and Brain Health in Older Adults At-risk for Diabetes: A Feasibility Pilot Study|
|Actual Study Start Date :||November 2, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||February 2020|
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.
- 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 [ Time Frame: Baseline and 6 months ]For this task, participants will be asked to encode and then recall items (face or places) and items in conjunction (faces matched with places)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254381
|Contact: Lindsay S Nagamatsu, PhD||519-661-2111 ext email@example.com|
|London, Ontario, Canada|
|Contact: Lindsay S Nagamatsu, PhD|
|Principal Investigator:||Lindsay S Nagamatsu||Western University|