Centre- versus home-based exercise among people with mci and mild dementia: study protocol for a randomized parallel-group trial

Laura E Middleton, Sandra E Black, Nathan Herrmann, Paul I Oh, Kayla Regan, Krista L Lanctot, Laura E Middleton, Sandra E Black, Nathan Herrmann, Paul I Oh, Kayla Regan, Krista L Lanctot

Abstract

Background: Worldwide, almost 50million people lived with dementia in 2016. A cure or disease modifying pharmaceutical treatment for dementia remains elusive so alternative therapies are of critical importance. Mounting evidence supports exercise in the prevention and therapy of dementia. However, the cognitive, physical, and psychological challenges common to dementia along with a poor understanding and accommodation of dementia in the community are major barriers to exercise. Consequently, effective delivery options need to be identified. The primary objective of this study is to compare the effectiveness of center-based (CB) exercise versus home-based (HB) exercise for achievement of physical activity guidelines among people with MCI or mild dementia.

Methods: This is a randomized parallel-group trial comparing the effects of CB and HB exercise adherence among community-dwelling adults ≥50 years with a clinical diagnosis of MCI or mild dementia. Participants will be randomized to either CB or HB exercise. The CB group will meet weekly for small group exercise and will be prescribed additional exercise to be completed independently. Participants in the HB group will be given a physical activity prescription to be completed independently in the community. Participants in HB will also be contacted by phone monthly to adjust exercise prescriptions. The primary outcome will be achievement of exercise guidelines (150 min/wk. of moderate activity) assessed using an activity monitor. Secondary objectives will evaluate cost-effectiveness and the influence of individual and environmental factors on the primary outcome. Tertiary outcomes include physical function, cognition, mood, and quality of life.

Discussion: There is scant research to indicate the most effective way to deliver exercise to people with MCI and mild dementia, which is needed specifically because these groups face significant barriers to exercise. To capitalize on the benefits of exercise, feasible exercise delivery options need to be identified. The results of this study will directly complement ongoing clinical trials and will be essential to implementing exercise recommendations specific to the prevention and therapy of dementia in a feasible and cost-effective manner when they emerge.

Trial registration: Clinicatrials.gov ; Identifier: NCT02774720 (version updated December 12, 2016).

Keywords: Clinical trial; Delivery of health care; Dementia; Exercise; Mild cognitive impairment.

Conflict of interest statement

Ethics approval and consent to participate

This study has received ethics clearance through a University of Waterloo Research Ethics Committee, the Tri-Hospital Research Ethics Board, the Sunnybrook Research Ethics Board, and the University Health Network Research Ethics Board. All participants will either provide written informed consent to participate in the study or provide assent to have a substitution decision maker provide informed consent on their behalf.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow of study participants

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