Mild Cognitive ImpairmentCHIMENCT02774720
Centre- Versus Home-based Exercise for MCI and Early Dementia
A study testing Centre-based exercise and Home-based exercise in people with Mild Cognitive Impairment and Dementia, run by University of Waterloo at 2 sites in Canada.
Trial summary
The study is a proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations. The primary outcome is achievement of physical activity recommendations. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dementia
- What is being tested?
- Centre-based exercise and Home-based exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2016to Mar 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MCI or mild dementia
- Mini-Mental State Examination (MMSE)>=23 or Montreal Cognitive Assessment (MoCA)>=18
- 50 years or older
- Stable pharmaceutical regimen >=2 months
- Be able to travel to centre
- Have a care partner or significant other to support home-based exercise
Show all 11Show fewer
- Ability to walk >=2 minutes
- Adequate English to understand exercise training
- Adequate hearing and vision for cognitive tests
- Able to comply with assessment and training schedule
- Be screened safe for exercise by a physician or certified exercise physiologist
Who cannot join
- Current moderate or high intensity exercise >=3 times per week
- Unstable cardiovascular disease that precludes exercise
- Musculoskeletal impairments that limit ability to walk
- Pain or other co-morbidities that would limit exercise
- Behavioural issues that would limit exercise training
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
University of Waterloo
Waterloo, Ontario, N2L3G1
About this study
Official title: How do we Get People With MCI and Dementia to be Physically Active?
The study is a proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations. The primary outcome is achievement of physical activity recommendations. Secondary outcomes include cost-effectiveness and improvements in health and function.
Read the detailed description
The aim of this trial is to compare the effectiveness of center-based versus home-based physical activity delivery among people with MCI and early dementia and to understand the influence of person and setting characteristics.
OBJECTIVES:
Primary: To compare the effectiveness of centre-based versus home-based physical activity delivery among people with MCI or early dementia, as measured by percent achievement of physical activity guidelines.
Secondary:
(i) To determine the influence of person- and setting-specific factors. (ii) To estimate the cost-effectiveness of centre-based and home-based physical activity.
Exploratory:
- To compare the effect of centre- and home-based physical activity on other outcomes. ii) To explore whether participants consider certain aspects of the program to be important to program effectiveness.
METHODS:
The investigators will conduct a 3-month proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations.
Participants will be randomized to one of two physical activity delivery options.The goal of both arms will be to have participants reach physical activity guidelines by the end of the 3-month intervention.
Participants who are randomized to centre-based physical activity will attend physical activity programming at a centre (University of Waterloo or Toronto Rehabilitation Institute) once per week for one hour. Additional physical activity will be prescribed at home.
Participants who are randomized to the home-based physical activity will received a physical activity prescription to be completed at home. They will also receive monthly support calls to assess achievements and barriers and to adjust the prescription.
All assessors will be blinded to group allocation.
- Conditions
- Mild Cognitive Impairment, Dementia
- Being tested
- Centre-based exercise, Home-based exercise
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centre-based exerciseBehavioural
Participants will come to a centre (University of Waterloo or Toronto Rehabilitation Institute) for a one-hour, small group exercise class each week. The classes will include progressive aerobic and resistance exercise. They will be prescribed additional exercise to be performed independently (either at home or in the community).
Home-based exerciseBehavioural
Participants will be prescribed aerobic and resistance exercise to be performed independently (either at home or in the community). They will receive monthly phone calls to discuss achievements and barriers and to tje adjust exercise prescription.
| Study group | Role | What they receive |
|---|---|---|
| Centre-based physical activity | Experimental | People with Mild Cognitive Impairment (MCI) and early dementia will receive centre-based physical activity for one hour each week for three months, plus at-home prescribed exercise. Receives: Behavioral: Centre-based exercise |
| Home-based exercise | Experimental | People with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls. Receives: Behavioral: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Physical Activity
Percent achievement of physical activity recommendations (150min/wk of moderate or high intensity physical activity) as objectively measured using an activity monitor.
Measured: 3 months
Change in physical activity
Change in physical activity as objectively measured using an activity monitor.
Measured: baseline to 3 months
Secondary outcomes (1)
Cost-effectiveness
Cost of resource utilization per minute change in physical activity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019
- Study completionMar 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 Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774720
- Sponsor's protocol ID
- 20687
- Acronym
- CHIME
- Status last verified
- Sep 2018
- First submitted
- 7 Apr 2016
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Middleton LE, Black SE, Herrmann N, Oh PI, Regan K, Lanctot KL. Centre- versus home-based exercise among people with mci and mild dementia: study protocol for a randomized parallel-group trial. BMC Geriatr. 2018 Jan 25;18(1):27. doi: 10.1186/s12877-017-0684-0.
PubMed 29370756
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do we Get People With MCI and Dementia to be Physically Active?
- ClinicalTrials.gov ID
- NCT02774720
- Acronym / sponsor ID
- CHIME / 20687
- Conditions
- Mild Cognitive Impairment, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 17 May 2016 (estimated)
- 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.
The study is a proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations. The primary outcome is achievement of physical activity recommendations. Secondary outcomes include cost-effectiveness and improvements in health and function.
Detailed description
The aim of this trial is to compare the effectiveness of center-based versus home-based physical activity delivery among people with MCI and early dementia and to understand the influence of person and setting characteristics.
OBJECTIVES:
Primary: To compare the effectiveness of centre-based versus home-based physical activity delivery among people with MCI or early dementia, as measured by percent achievement of physical activity guidelines.
Secondary:
(i) To determine the influence of person- and setting-specific factors. (ii) To estimate the cost-effectiveness of centre-based and home-based physical activity.
Exploratory:
- To compare the effect of centre- and home-based physical activity on other outcomes. ii) To explore whether participants consider certain aspects of the program to be important to program effectiveness.
METHODS:
The investigators will conduct a 3-month proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations.
Participants will be randomized to one of two physical activity delivery options.The goal of both arms will be to have participants reach physical activity guidelines by the end of the 3-month intervention.
Participants who are randomized to centre-based physical activity will attend physical activity programming at a centre (University of Waterloo or Toronto Rehabilitation Institute) once per week for one hour. Additional physical activity will be prescribed at home.
Participants who are randomized to the home-based physical activity will received a physical activity prescription to be completed at home. They will also receive monthly support calls to assess achievements and barriers and to adjust the prescription.
All assessors will be blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Centre-based physical activity | Experimental | Behavioral: Centre-based exercisePeople with Mild Cognitive Impairment (MCI) and early dementia will receive centre-based physical activity for one hour each week for three months, plus at-home prescribed exercise. |
| Home-based exercise | Experimental | Behavioral: Home-based exercisePeople with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of MCI or mild dementia
- Mini-Mental State Examination (MMSE)>=23 or Montreal Cognitive Assessment (MoCA)>=18
- 50 years or older
- Stable pharmaceutical regimen >=2 months
- Be able to travel to centre
Key exclusion criteria (5 listed)
- Current moderate or high intensity exercise >=3 times per week
- Unstable cardiovascular disease that precludes exercise
- Musculoskeletal impairments that limit ability to walk
- Pain or other co-morbidities that would limit exercise
- Behavioural issues that would limit exercise training
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 |
|---|---|---|
| Centre-based exerciseParticipants will come to a centre (University of Waterloo or Toronto Rehabilitation Institute) for a one-hour, small group exercise class each week. The classes will include progressive aerobic and resistance exercise. They will be prescribed additional exercise to be performed independently (either at home or in the community). | Behavioural | Centre-based physical activity |
| Home-based exerciseParticipants will be prescribed aerobic and resistance exercise to be performed independently (either at home or in the community). They will receive monthly phone calls to discuss achievements and barriers and to tje adjust exercise prescription. | Behavioural | Home-based exercise |
Primary outcome
Achievement of Physical Activity
Time frame: 3 months
Percent achievement of physical activity recommendations (150min/wk of moderate or high intensity physical activity) as objectively measured using an activity monitor.
Change in physical activity
Time frame: baseline to 3 months
Change in physical activity as objectively measured using an activity monitor.
1 secondary outcome
Cost-effectiveness
Time frame: 3 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 29 May 2019.
- Derived from this study: PubMed 29370756Middleton LE, Black SE, Herrmann N, Oh PI, Regan K, Lanctot KL. Centre- versus home-based exercise among people with mci and mild dementia: study protocol for a randomized parallel-group trial. BMC Geriatr. 2018 Jan 25;18(1):27. doi: 10.1186/s12877-017-0684-0.
- Individual participant dataSharing planned: Undecided
Related trials for Mild Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Recruiting
Combating Alzheimer's Through Sleep and Exercise
Dementia, Mild Cognitive Impairment (MCI)
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centre-based exercise and Home-based exercise in people with Mild Cognitive Impairment and Dementia, run by University of Waterloo at 2 sites 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 11 inclusion and 5 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 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Achievement of Physical Activity (time frame: 3 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 NCT02774720, 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 29 May 2019; AzTrials last refreshed its copy on 1 Nov 2026.