Clinical trial NCT02774720: Centre- Versus Home-based Exercise for MCI and Early Dementia
Official title: How do we Get People With MCI and Dementia to be Physically Active?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2016-05-17
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Achievement of Physical Activity
timeFrame: 3 months
measure: Change in physical activity
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 3 months
Other outcomes:
measure: Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)
timeFrame: baseline to 3 months
measure: Change in cognitive function as characterized by the Stroop task
timeFrame: baseline to 3 months
measure: Change in cognitive function as characterized by the Trail making task
timeFrame: baseline to 3 months
measure: Change in cognitive function as characterized by the semantic fluency
timeFrame: baseline to 3 months
measure: Change in physical function as characterized by the Short Physical Performance Battery (SPPB) scores
timeFrame: baseline to 3 months
measure: Change in quality of life as measured with the EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: baseline to 3 months
measure: Change in mood as measured with the Neuropsychiatric Inventory Questionnaire (NPI-Q) (depression/dysphoria, anxiety, apathy/indifference scales)
timeFrame: baseline to 3 months
measure: Change in daily function as characterized using the 6-item Disability Assessment for Dementia (DAD-6)
timeFrame: baseline to 3 months
measure: Change in body mass index (BMI)
timeFrame: baseline to 3 months
measure: Change in waist circumference
timeFrame: baseline to 3 months
measure: Change in blood pressure
timeFrame: baseline to 3 months
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
References:
citation: 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.