Exercise in Older Adults at Risk for Type 2 Diabetes

NCT05229705 | Completed

• 1 other identifier: 120336
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Older adults with type 2 diabetes experience neurocognitive decline and are at higher risk for developing dementia. Consequently, older adults at-risk for developing type 2 diabetes (i.e., those who are overweight and/or prediabetic) are at higher risk for neurocognitive 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 and brain health in other populations is resistance exercise. We previously conducted a 6-month resistance training randomized controlled trial (RCT) pilot study that showed a large scale trial would be viable and feasible. Consequently, we would like to explore resistance exercise as a lifestyle intervention to improve cognition and brain structure in older adults at risk for diabetes.

Conditions

Cognitive Change

Keywords

resistance exercise; cognition; brain health; older adults; diabetes; obesity

Outcome Measures

Primary Outcomes (1)

• Trail Making Test

  Used to assess executive function in the areas of visual attention (Part A) and set-shifting (the ability to shift attention between one task and another; Part B). The time to complete this test is recorded in seconds.

  5 minutes

Secondary Outcomes (20)

• Paired Associative Learning (PAL) Touchscreen Task

  20 minutes

• Trail Unique-Non-Matching-Location (TUNL) Task

  20 minutes

• Progressive Ratio (PR) Touchscreen Task

  20 minutes

• Stroop Test

  5-10 minutes

• Digit Span Test

  5-10 minutes

Study Arms (2)

Resistance exercise

EXPERIMENTAL

Exercises will be completed in Kevin Shoemaker's (Co-I) exercise lab in the Health Sciences Building. Participants will use the programmable weight machines along with free weights to target the 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. We will record the number of sets completed and the load lifted for each exercise for each participant at every class.

Behavioral: Resistance exercise

Control (balance and tone exercise)

NO INTERVENTION

Exercises will be completed in the Health Science Exercise lab. These 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 (Liu-Ambrose et al., 2010; Liu-Ambrose et al., 2012; Nagamatsu et al., 2012; Nagamatsu et al., 2013).

Interventions

Resistance exercise BEHAVIORAL

Participants in this exercise group will receive progressive resistance training.

Resistance exercise

Eligibility Criteria

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

You may qualify if:

• Community-dwelling
• Aged 60-80 years
• "At-risk" for diabetes, where they have one of the following: i) blood glucose level of 6.1-7 mmol/L, ii) body mass index \> 25, or iii) score \> 21 on the CANRISK diabetes questionnaire
• Score \> 24/30 on MMSE
• Score \> 6/8 on the IADL scale
• Visual acuity of at least 20/40, with or without corrective lenses
• Speak and understand English fluently
• Complete the PAR-Q
• Obtain physician's clearance to start a supervised exercise program

You may not qualify if:

• Current medical condition for which exercise is contraindicated
• Participated regularly in resistance or aerobic training in the last 6 months
• Diagnosed with neurodegenerative disease (including dementia, Alzheimer's disease, or Parkinson's disease)
• Experienced a vascular incident (e.g., stroke, myocardial infarction)
• Diagnosed with a psychiatric condition
• Untreated depression and scored 5 or less on the Geriatric Depression Scale
• Currently on hormone replacement therapy
• Clinically significant peripheral neuropathy or severe musculoskeletal or joint disease
• Currently taking psychotropic medications
• Cannot blood draw

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Western University

London, Ontario, N6A 5B7, Canada

Location

Related Publications (4)

• Furlano JA, Nagamatsu LS. Feasibility of a 26-Week Exercise Program to Improve Brain Health in Older Adults at Risk for Type 2 Diabetes: A Pilot Study. Can J Diabetes. 2021 Aug;45(6):546-552. doi: 10.1016/j.jcjd.2020.11.001. Epub 2020 Nov 13.

  PMID: 33358932 BACKGROUND

• Liu-Ambrose T, Nagamatsu LS, Graf P, Beattie BL, Ashe MC, Handy TC. Resistance training and executive functions: a 12-month randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):170-8. doi: 10.1001/archinternmed.2009.494.

  PMID: 20101012 BACKGROUND

• Nagamatsu LS, Handy TC, Hsu CL, Voss M, Liu-Ambrose T. Resistance training promotes cognitive and functional brain plasticity in seniors with probable mild cognitive impairment. Arch Intern Med. 2012 Apr 23;172(8):666-8. doi: 10.1001/archinternmed.2012.379. No abstract available.

  PMID: 22529236 BACKGROUND

• Awad N, Gagnon M, Messier C. The relationship between impaired glucose tolerance, type 2 diabetes, and cognitive function. J Clin Exp Neuropsychol. 2004 Nov;26(8):1044-80. doi: 10.1080/13803390490514875.

  PMID: 15590460 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 Nagamatsu, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and accessors will be blinded to group allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Experimental group versus control group

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 8, 2022
• Study Start: September 23, 2022
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)