Status:
ACTIVE_NOT_RECRUITING
The Lifestyle Exercise and Diet Trial (LEAD) 2.0
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Baycrest
Université de Montréal
Conditions:
Subjective Cognitive Decline
Eligibility:
All Genders
65-80 years
Phase:
NA
Brief Summary
The objective of this study is to investigate the feasibility of a virtually-delivered 6-month exercise and nutrition intervention in older adults with executive subjective cognitive decline (SCD). Fe...
Detailed Description
The study will be a randomized control trial examining the feasibility of a 6-month virtually delivered exercise and nutrition intervention in older adults with executive SCD. The study aims to recrui...
Eligibility Criteria
Inclusion
- 65-80 years old
- Meet criteria for executive SCD
- Answer Yes to both following questions:
- Do you feel like your memory or thinking is becoming worse?
- Does this worry you?
- ≥1SD above age and sex-based means on any of the sub scales of the Comprehensive Executive Function Inventory (CEFI) - Adult Version, indicative of concerns about executive function.
- No objective cognitive impairment as indicated by:
- A global Clinical Dementia Rating (CDR) of ≤ 0.5
- A Blind Montreal Cognitive Assessment (MoCA) total score of \>17
- Able to communicate in English
- Residents of Quebec, Ontario, Manitoba, and Saskatchewan to facilitate concurrent intervention delivery
- Low physical activity levels (\<75min/week of moderate/vigorous physical activity on the Get Active Questionnaire)
- Screened safe to participate in moderate exercise using the Get Active Questionnaire or physician approval to engage in moderate intensity exercise without in-person supervision
- Poor diet quality (below Canadian older adults' median intake of fruits, vegetables, nuts and fish, reported using our Diet Screening Questionnaire)
- Able to participate remotely (i.e., availability of, or ability/willingness to adopt, a computer or tablet alongside high speed internet/data networks)
Exclusion
- Dementia, stroke, or other chronic brain disease
- Chemotherapy or radiation to the head/neck in the past year
- Sensory impairments that would impede participation in the intervention or assessments
- Major psychiatric disorder
- Ongoing alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
- Contraindications for exercise as determined by the American College of Sports Medicine criteria
Key Trial Info
Start Date :
October 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06078748
Start Date
October 3 2023
End Date
December 1 2025
Last Update
April 4 2025
Active Locations (1)
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1
University of Waterloo
Waterloo, Ontario, Canada, 41080