Centre- Versus Home-based Exercise for MCI and Early Dementia (CHIME)

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Centre-based exercise; Behavioral: Home-based exercise

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:

i) 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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
    • Waterloo, Ontario, Canada, N2L3G1
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Centre-based physical activity; 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.	Behavioral: Centre-based exercise; 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).
Experimental: Home-based exercise; People with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls.	Behavioral: Home-based exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
Change in physical activity	Change in physical activity as objectively measured using an activity monitor.	baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness	Cost of resource utilization per minute change in physical activity.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)	Change in continuous scores	baseline to 3 months
Change in cognitive function as characterized by the Stroop task	Change in continuous scores	baseline to 3 months
Change in cognitive function as characterized by the Trail making task	Change in continuous scores	baseline to 3 months
Change in cognitive function as characterized by the semantic fluency	Change in continuous scores	baseline to 3 months
Change in physical function as characterized by the Short Physical Performance Battery (SPPB) scores	Change in continuous scores	baseline to 3 months
Change in quality of life as measured with the EuroQol five dimensions questionnaire (EQ-5D)	Change in continuous scores	baseline to 3 months
Change in mood as measured with the Neuropsychiatric Inventory Questionnaire (NPI-Q) (depression/dysphoria, anxiety, apathy/indifference scales)	Change in scores, number meeting screening criteria for depression	baseline to 3 months
Change in daily function as characterized using the 6-item Disability Assessment for Dementia (DAD-6)	Change in score	baseline to 3 months
Change in body mass index (BMI)	Change in score	baseline to 3 months
Change in waist circumference	Change in score	baseline to 3 months
Change in blood pressure	Change in number with high blood pressure (>140 systolic blood pressure (SBP), >90 diastolic blood pressure (DBP))	baseline to 3 months

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Alzheimer's Association

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 27, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: 20687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided