Lifestyle, Exercise and Diet: The LEAD Study

NCT03056508 | Terminated

• 1 other identifier: CCNA-NELT
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

diet; nutrition; aerobic exercise; cognition; grey matter; cerebral blood flow; neural activity; resting state connectivity

Outcome Measures

Primary Outcomes (1)

• Changes from baseline brain structure at 6 months and 12 months.

  Cortical and subcortical grey matter density using MRI three-dimensional T1 weighted structural scan (MPRAGE)

  6 months plus 6 month follow-up

Secondary Outcomes (20)

• Changes from baseline cerebral blood flow at 6 months and 12 months.

  6 months plus 6 month follow-up

• Changes from baseline cognition at 6 months and 12 months

  6 months plus 6 month follow-up

• Changes from baseline brain activity related to attention at 6 months and 12 months

  6 months plus 6 month follow-up

• Changes from baseline resting state connectivity at 6 months and 12 months

  6 months plus 6 month follow-up

• Changes from baseline diet quality at 6 months and 12 months

  6 months plus 6 month follow-up

Study Arms (2)

Exercise plus Nutrition

EXPERIMENTAL

6 months of supervised group exercise plus education and strategy training to alter diet to be consistent with recommendations outlined in our brain health food guide (BHFG).

Behavioral: Exercise plus nutrition

Exercise

ACTIVE COMPARATOR

Identical exercise to the experimental plus education and passive discussion about brain health and healthy lifestyle to control for experimental group nutrition sessions.

Behavioral: Exercise

Interventions

Exercise plus nutrition BEHAVIORAL

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.

Exercise plus Nutrition

Exercise BEHAVIORAL

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.

Exercise

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meeting criteria for subjective cognitive impairment (1 through 5 below)
• Answer Yes to both following questions:
• Do you feel like your memory or thinking is becoming worse?
• Does this concern you?
• Have a delayed recall score on 1 paragraph of the Logical Memory test (Wechsler Memory Scale, maximum score 25) above the education-adjusted cut-offs:
• ≥9 for 16+ years of education;
• ≥5 for 8-15 years of education;
• ≥3 for 0-7 years of education.
• Have a Montreal Cognitive Assessment (MoCA) total score of 20 and over (≥20/30).
• Have a delayed recall score on the CERAD word list of 5 and over (≥5).
• Have a global Clinical Dementia Rating score (CDR) equal to 0.5 or less (≤0.5).
• ≥2 vascular risk factors (overweight (BMI\>25), T2DM, hypercholesterolemia or hypertension),
• Consuming a poor quality diet (at least median or below on number of servings of vegetable, fruit, fish and nuts based on Canadian consumption patterns in older adults)
• Reasonably sedentary (less than 75min per week of moderate - vigorous intensity physical activity)
• Be available for the whole intervention (6 months) and a 12- month follow-up visit

You may not qualify if:

• The presence of significant known chronic brain disease such as: moderate to severe chronic static leukoencephalopathy (including previous traumatic injury), multiple sclerosis, a serious developmental handicap, malignant tumors, Parkinson's disease, and other rarer brain illnesses.
• 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.
• Subject does not have a study partner who can provide corroborative information.
• Symptomatic stroke within the previous year.
• Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure.
• Major surgery within last 2 months.
• History of intracranial surgery
• Serious comorbid condition that, in the opinion of the study investigator, is likely to result in death within a year.
• High performance athletes

Sponsors & Collaborators

• Rotman Research Institute at Baycrest: lead
• Sunnybrook Health Sciences Centre: collaborator
• Toronto Rehabilitation Institute: collaborator
• The Centre for Memory and Aging: collaborator
• University of Waterloo: collaborator

Study Sites (4)

Toronto Rehabilitation Institute Rumsey Centre

Toronto, Ontario, M4G 2V6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Rotman Research Institute

Toronto, Ontario, M6A 2E1, Canada

Location

Centre for Community, Clinical Applied Research Excellence (CCCARE) at the University of Waterloo

Waterloo, Ontario, Canada

Location

Related Publications (1)

• Koblinsky ND, Anderson ND, Ajwani F, Parrott MD, Dawson D, Marzolini S, Oh P, MacIntosh B, Middleton L, Ferland G, Greenwood CE. Feasibility and preliminary efficacy of the LEAD trial: a cluster randomized controlled lifestyle intervention to improve hippocampal volume in older adults at-risk for dementia. Pilot Feasibility Stud. 2022 Feb 9;8(1):37. doi: 10.1186/s40814-022-00977-6.

  PMID: 35139918 DERIVED

MeSH Terms

Interventions

Exercise; Nutritional Status

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Carol E Greenwood, PhD

  Rotman Research Institute Baycrest Health Sciences

  PRINCIPAL INVESTIGATOR

• Nicole D Anderson, PhD

  Rotman Research Institute Baycrest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 17, 2017
• Study Start: July 1, 2018
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (4)