The Effect of Exercise on Cognition in Older Adults At-risk for Diabetes: A Feasibility Pilot Study

NCT03254381 | Completed

• 1 other identifier: 109379
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Keywords

cognitive assessment; cognitive function; community dwelling older people; pre-diabetes; randomized control trial; exercise; pilot study; feasibility study

Outcome Measures

Primary Outcomes (2)

• Number of participants recruited after 12 months

  12 months

• Number of exercise classes attended at trial completion (6 months)

  6 months

Secondary Outcomes (9)

• Change in cognitive function as measured by Alzheimer's Disease Assessment Scale - Cog - Plus (ADAS-Cog-Plus)

  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.

  Baseline and 6 months

• Change in hippocampal functional activation as measured during performance on associative memory task during fMRI scanning

  Baseline and 6 months

• Change in memory as measured by performance on associative memory task

  Baseline, 3 months, and 6 months

• Change in executive functions as measured by Stroop Test

  Baseline, 3 months, and 6 months

Study Arms (2)

Resistance Training

EXPERIMENTAL

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

Balance and Tone Training (Control)

EXPERIMENTAL

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

Interventions

Resistance Training BEHAVIORAL

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.

Resistance Training

Balance and Tone Training BEHAVIORAL

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.

Balance and Tone Training (Control)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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)

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Community

London, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 31585978 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Glucose Intolerance; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lindsay S Nagamatsu

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 18, 2017
• Study Start: November 2, 2017
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)