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

Primary Purpose

Cognitive Impairment

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Resistance Training

Balance and Tone Training

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring cognitive assessment, cognitive function, community dwelling older people, pre-diabetes, randomized control trial, exercise, pilot study, feasibility study

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

CommunityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Resistance Training

Balance and Tone Training (Control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants recruited after 12 months

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

Secondary Outcome Measures

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

Change in hippocampal volume as measured via high resolution T1 images collected during MRI scanning in both 3T and 7T machines.

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)

Change in memory as measured by performance on associative memory task

Change in executive functions as measured by Stroop Test

Change in aerobic fitness as measured by six minute walk test

Change in mobility and balance as measured by Short Physical Performance Battery

Change in muscle strength as measured by one-repetition maximum test

Change in blood glucose levels as measured by finger prick glucose test

Full Information

NCT ID

NCT03254381

First Posted

August 3, 2017

Last Updated

January 16, 2019

Sponsor

Western University, Canada

1. Study Identification

Unique Protocol Identification Number

NCT03254381

Brief Title

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

Official Title

The Effect of Resistance Training on Cognitive Function and Brain Health in Older Adults At-risk for Diabetes: A Feasibility Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 2, 2017 (Actual)

Primary Completion Date

June 2019 (Anticipated)

Study Completion Date

February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Resistance Training

Arm Type

Experimental

Arm Description

Arm Title

Balance and Tone Training (Control)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Resistance Training

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Balance and Tone Training

Intervention Description

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 Measure Information:

Title

Number of participants recruited after 12 months

Time Frame

12 months

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Description

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

Title

Change in memory as measured by performance on associative memory task

Time Frame

Baseline, 3 months, and 6 months

Title

Change in executive functions as measured by Stroop Test

Time Frame

Baseline, 3 months, and 6 months

Title

Change in aerobic fitness as measured by six minute walk test

Time Frame

Baseline, 3 months, and 6 months

Title

Change in mobility and balance as measured by Short Physical Performance Battery

Time Frame

Baseline, 3 months, and 6 months

Title

Change in muscle strength as measured by one-repetition maximum test

Time Frame

Baseline, 3 months, and 6 months

Title

Change in blood glucose levels as measured by finger prick glucose test

Time Frame

Baseline, 3 months, and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lindsay S Nagamatsu, PhD

Phone

519-661-2111

Ext

88284

lnagamat@uwo.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lindsay S Nagamatsu

Organizational Affiliation

Western University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Community

City

London

State/Province

Ontario

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lindsay S Nagamatsu, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31585978

Citation

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.

Results Reference

derived

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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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