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Completed

NCT Number: NCT02774720

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

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.

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Key information

Conditions

Mild Cognitive Impairment Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Research Institute, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Centre-based exercise

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. Change in physical activity

    Time frame: baseline to 3 months

    Change in physical activity as objectively measured using an activity monitor.

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 3 months

    Cost of resource utilization per minute change in physical activity.

Other outcomes

  1. Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)

    Time frame: baseline to 3 months

    Change in continuous scores

  2. Change in cognitive function as characterized by the Stroop task

    Time frame: baseline to 3 months

    Change in continuous scores

  3. Change in cognitive function as characterized by the Trail making task

    Time frame: baseline to 3 months

    Change in continuous scores

  4. Change in cognitive function as characterized by the semantic fluency

    Time frame: baseline to 3 months

    Change in continuous scores

  5. Change in physical function as characterized by the Short Physical Performance Battery (SPPB) scores

    Time frame: baseline to 3 months

    Change in continuous scores

  6. Change in quality of life as measured with the EuroQol five dimensions questionnaire (EQ-5D)

    Time frame: baseline to 3 months

    Change in continuous scores

  7. Change in mood as measured with the Neuropsychiatric Inventory Questionnaire (NPI-Q) (depression/dysphoria, anxiety, apathy/indifference scales)

    Time frame: baseline to 3 months

    Change in scores, number meeting screening criteria for depression

  8. Change in daily function as characterized using the 6-item Disability Assessment for Dementia (DAD-6)

    Time frame: baseline to 3 months

    Change in score

  9. Change in body mass index (BMI)

    Time frame: baseline to 3 months

    Change in score

  10. Change in waist circumference

    Time frame: baseline to 3 months

    Change in score

  11. Change in blood pressure

    Time frame: baseline to 3 months

    Change in number with high blood pressure (>140 systolic blood pressure (SBP), >90 diastolic blood pressure (DBP))

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alzheimer's Association

Registry information

Official study title

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

Acronym: CHIME

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 17, 2016
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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