Cognitive ImpairmentNCT03254381
The Effect of Exercise on Cognition in Older Adults At-risk for Diabetes: A Feasibility Pilot Study
A study testing Resistance Training and Balance and Tone Training in people with Cognitive Impairment, run by Western University, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Resistance Training and Balance and Tone Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 2 Nov 2017to 3 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Cognitive Impairment
- Being tested
- Resistance Training, Balance and Tone Training
- Keywords
- cognitive assessment, cognitive function, community dwelling older people, pre-diabetes, randomized control trial, exercise, pilot study, feasibility study
- Medical subject headings
- Cognitive Dysfunction, Glucose Intolerance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
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.
Balance and Tone TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Balance and Tone Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited after 12 months
Measured: 12 months
Number of exercise classes attended at trial completion (6 months)
Measured: 6 months
Secondary outcomes (9)
Change in cognitive function as measured by Alzheimer's Disease Assessment Scale - Cog - Plus (ADAS-Cog-Plus)
Measured: 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.
Measured: Baseline and 6 months
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)
Measured: Baseline and 6 months
Change in memory as measured by performance on associative memory task
Measured: Baseline, 3 months, and 6 months
Change in executive functions as measured by Stroop Test
Measured: Baseline, 3 months, and 6 months
Change in aerobic fitness as measured by six minute walk test
Measured: Baseline, 3 months, and 6 months
Change in mobility and balance as measured by Short Physical Performance Battery
Measured: Baseline, 3 months, and 6 months
Change in muscle strength as measured by one-repetition maximum test
Measured: Baseline, 3 months, and 6 months
Change in blood glucose levels as measured by finger prick glucose test
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start2 Nov 2017
- Primary completion3 Oct 2019
- Study completion3 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Nagamatsu, Western University, Canada
- Investigators
- Lindsay S Nagamatsu, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254381
- Sponsor's protocol ID
- 109379
- Status last verified
- Dec 2023
- First submitted
- 3 Aug 2017
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31585978
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistance Training on Cognitive Function and Brain Health in Older Adults At-risk for Diabetes: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT03254381
- Acronym / sponsor ID
- 109379
- Conditions
- Cognitive Impairment
- Keywords
- cognitive assessment, cognitive function, community dwelling older people, pre-diabetes, randomized control trial, exercise, pilot study, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training | Experimental | Behavioral: Resistance TrainingParticipants 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. |
| Balance and Tone Training (Control) | Experimental | Behavioral: Balance and Tone TrainingExercises 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingSix 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. | Behavioural | Resistance Training |
| Balance and Tone TrainingSix 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. | Behavioural | Balance and Tone Training (Control) |
Primary outcome
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
9 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 31585978Furlano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay S Nagamatsu principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training and Balance and Tone Training in people with Cognitive Impairment, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited after 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03254381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.