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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
Sponsor:
Information provided by (Responsible Party):
Lindsay Nagamatsu, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Behavioral: Resistance Training Behavioral: Balance and Tone Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of participants recruited after 12 months [ Time Frame: 12 months ]
  2. Number of exercise classes attended at trial completion (6 months) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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)

  4. Change in memory as measured by performance on associative memory task [ Time Frame: Baseline, 3 months, and 6 months ]
  5. Change in executive functions as measured by Stroop Test [ Time Frame: Baseline, 3 months, and 6 months ]
  6. Change in aerobic fitness as measured by six minute walk test [ Time Frame: Baseline, 3 months, and 6 months ]
  7. Change in mobility and balance as measured by Short Physical Performance Battery [ Time Frame: Baseline, 3 months, and 6 months ]
  8. Change in muscle strength as measured by one-repetition maximum test [ Time Frame: Baseline, 3 months, and 6 months ]
  9. Change in blood glucose levels as measured by finger prick glucose test [ Time Frame: Baseline, 3 months, and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

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


Contacts
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Contact: Lindsay S Nagamatsu, PhD 519-661-2111 ext 88284 lnagamat@uwo.ca

Locations
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Canada, Ontario
Community Recruiting
London, Ontario, Canada
Contact: Lindsay S Nagamatsu, PhD         
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Lindsay S Nagamatsu Western University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lindsay Nagamatsu, Assistant Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT03254381     History of Changes
Other Study ID Numbers: 109379
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lindsay Nagamatsu, Western University, Canada:
cognitive assessment
cognitive function
community dwelling older people
pre-diabetes
randomized control trial
exercise
pilot study
feasibility study
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders