Centre- Versus Home-based Exercise for MCI and Early Dementia

Dementia Clinical Trial

— CHIME  

Official title:

How do we Get People With MCI and Dementia to be Physically Active?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774720
• Other study ID #: 20687
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: September 2018
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Secondary outcomes include cost-effectiveness and improvements in health and function.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

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).
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Research Institute	Toronto	Ontario
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Alzheimer's Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)	Change in continuous scores	baseline to 3 months
Other	Change in cognitive function as characterized by the Stroop task	Change in continuous scores	baseline to 3 months
Other	Change in cognitive function as characterized by the Trail making task	Change in continuous scores	baseline to 3 months
Other	Change in cognitive function as characterized by the semantic fluency	Change in continuous scores	baseline to 3 months
Other	Change in physical function as characterized by the Short Physical Performance Battery (SPPB) scores	Change in continuous scores	baseline to 3 months
Other	Change in quality of life as measured with the EuroQol five dimensions questionnaire (EQ-5D)	Change in continuous scores	baseline to 3 months
Other	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
Other	Change in daily function as characterized using the 6-item Disability Assessment for Dementia (DAD-6)	Change in score	baseline to 3 months
Other	Change in body mass index (BMI)	Change in score	baseline to 3 months
Other	Change in waist circumference	Change in score	baseline to 3 months
Other	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
Primary	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
Primary	Change in physical activity	Change in physical activity as objectively measured using an activity monitor.	baseline to 3 months
Secondary	Cost-effectiveness	Cost of resource utilization per minute change in physical activity.	3 months