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Trial record 1 of 1 for:    NCT02774720
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Centre- Versus Home-based Exercise for MCI and Early Dementia (CHIME)

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ClinicalTrials.gov Identifier: NCT02774720
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
University of Waterloo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dementia Behavioral: Centre-based exercise Behavioral: Home-based exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: How do we Get People With MCI and Dementia to be Physically Active?
Study Start Date : September 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 3 months ]
    Cost of resource utilization per minute change in physical activity.


Other Outcome Measures:
  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))


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774720


Locations
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Canada, Ontario
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
University of Waterloo
Waterloo, Ontario, Canada, N2L3G1
Sponsors and Collaborators
University of Waterloo
Alzheimer's Association
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT02774720    
Other Study ID Numbers: 20687
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders