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

University of Waterloo

Status: Completed

Conditions: Mild Cognitive Impairment; Dementia

Treatments: Behavioral: Centre-based exercise; Behavioral: Home-based exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02774720

20687

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 2 patient groups

Centre-based physical activity

Experimental group

Description:

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.

Treatment:

Behavioral: Centre-based exercise

Home-based exercise

Experimental group

Description:

People with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls.

Treatment:

Behavioral: Home-based exercise