Lifestyle, Exercise and Diet: The LEAD Study

Summary

This study will explore the impact of an exercise and nutrition (EX+NUTR) , relative to exercise alone (EX) intervention, on brain structure and function as well as blood biomarkers in older adults with subjective cognitive decline (SCD) and vascular risk factors. The overall hypotheses are that a combined EX+NUTR, relative to EX, intervention will evoke more positive changes in brain structure (e.g. hippocampal volume), neural activity (e.g. task associated functional activations monitored through fMRI), and cognitive performance. These changes will be associated with an improved metabolic profile, reductions in inflammatory cytokines and oxidative burden, and greater intervention compliance.

Conditions

• Subjective Cognitive Decline
• Age-Related Cognitive Decline

Interventions

BEHAVIORAL

Exercise plus nutrition

On the same day as the exercise class, participants will also receive nutrition support. Participants will alter their overall diet to be consistent with recommendations outlined in our brain health food guide (BHFG) and receive diet counseling and strategy training to promote retention and enable this dietary change. For the first two months, diet group sessions will be held on a weekly basis. For the remaining four months, sessions will be divided between group sessions and individual meetings with study dietitians, on a predefined schedule. Participants will submit weekly logs outlining diet goals, plans, successes and obstacles to help direct identification of sequential goals.

BEHAVIORAL

Exercise

Supervised group exercise will be performed once per week (60 minutes) and self-directed exercise (4 additional aerobic and 2-3 resistance training sessions per week) will be monitored by an exercise diary. The initial walking prescription will be set at \~1.6 km and an intensity equivalent to the anaerobic threshold and/or 60% VO2-peak. Progressions will be made every 2 weeks, increasing distance to a maximum of 6.4 km and then increasing to a max intensity of 80% of VO2-peak and/or max duration of 60 minutes. Heart rate and perceived exertion will be monitored. The program will last 6 months.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Toronto Rehabilitation Institute

  collaborator OTHER

• The Centre for Memory and Aging

  collaborator UNKNOWN

• University of Waterloo

  collaborator OTHER

• Rotman Research Institute at Baycrest

  lead OTHER

Principal Investigators

• Carol E Greenwood, PhD · Rotman Research Institute Baycrest Health Sciences

• Nicole D Anderson, PhD · Rotman Research Institute Baycrest Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2020-10-08

Completion

2020-10-08

Countries

• Canada

Study Locations